Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
double-blind, PI3Kdelta, GSK2269557, exacerbation, Chronic Obstructive Pulmonary Disease, randomised, placebo-controlled
Brief summary
The purpose of this study is to evaluate specific alterations in immune cell mechanisms related to neutrophil function as detected by PI3Kdelta-dependent changes in messenger ribonucleic acid (mRNA) extracted from induced sputum in patients experiencing an exacerbation of COPD, with or without treatment with GSK2269557. The efficacy of treatment with GSK2269557 will also be measured using functional respiratory imaging (FRI) and spirometry. This is a randomised, double-blind, placebo-controlled, parallel-group study. The study consisted of Screening Phase (up to 3 days prior to Day 1), Treatment Phase (Days 1 to 84) and Follow phase (7 to 14 days after last dose). The total duration of the study is 13-14 weeks including the screening visit. DISKUS TM and ELLIPTA TM are registered trademark of GSK group of companies.
Interventions
DRUGGSK2269557
GSK2269557 500 mcg blended with lactose per blister and will be administered using a DISKUS dry powder inhaler device. Since GSK2269557 will no longer be manufactured for use with the DISKUS device, it will be replaced with ELLIPTA Device. Subjects will receive GSK2269557 700 mcg once daily for 84 consecutive days via ELLIPTA.
DRUGPlacebo
Lactose will be administered using a DISKUS and ELLIPTA dry powder inhaler device
DEVICEDISKUS
It is multi-dose dry powder inhaler containing one foil strip of drug with 60 blisters
DEVICEELLIPTA
It is multi-dose dry powder inhaler containing one foil strip of drug with 30 blisters
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Between 40 and 80 years of age inclusive, at the time of signing the informed consent. * The subject has a confirmed and established diagnosis of COPD, as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for at least 6 months prior to entry. * The subject is able to produce \>100 milligram (mg) of sputum at screening for processing, (ie, total weight of sputum plugs). * The subject has a post-bronchodilator FEV1/FVC \<0.7 and FEV1 \<=80 % of predicted. * Disease severity: Acute exacerbation of COPD requiring an escalation in therapy to include both corticosteroid and antibiotics. Acute exacerbation to be confirmed by an experienced physician and represent a recent change in at least two major and one minor symptoms, one major and two minor symptoms, or all 3 major symptoms. Major symptoms: Subjective increase in dyspnea; Increase in sputum volume; Change in sputum colour. Minor symptoms: Cough; Wheeze; Sore throat * The subject is a smoker or an ex-smoker with a smoking history of at least 10 pack years (pack years = \[cigarettes per day smoked/20 x number of years smoked\]). * Body weight \>= 45 kilogram (kg) and body mass index (BMI) within the range 16 to 35 kilogram per meter square (kg/m\^2) (inclusive) * Male * Female subject: is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin \[hCG\] test), not lactating, and at least one of the following conditions applies: (1)Non-reproductive potential defined as: Pre-menopausal females with one of the following: Documented tubal ligation; Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; Hysterectomy; Documented Bilateral Oophorectomy. Postmenopausal defined as 12 months of spontaneous amenorrhea. Females whose menopausal status is in doubt will be required to use, or have been using, one of the highly effective contraception methods as specified below from 30 days prior to the first dose of study medication and until completion of the follow-up visit. 2)Reproductive potential and agrees to follow one of the options listed below in the GlaxoSmithKline (GSK) Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) requirements from 30 days prior to the first dose of study medication and until completion of the follow-up visit. GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in FRP. This list does not apply to FRP with same sex partners, when this is their preferred and usual lifestyle or for subjects who are and will continue to be abstinent from penile-vaginal intercourse on a long term and persistent basis. 1) Contraceptive subdermal implant that meets GSK standard criteria including a \<1% rate of failure per year, as stated in the product label. 2) Intrauterine device or intrauterine system that meets GSK standard criteria including a \<1% rate of failure per year, as stated in the product label. 3) Oral Contraceptive, either combined or progestogen alone. 4) Injectable progestogen. 5) Contraceptive vaginal ring. 6) Percutaneous contraceptive patches. 7) Male partner sterilization with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject. 8) Male condom combined with a vaginal spermicide (foam, gel, film, cream, or suppository). These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. Specific inclusion criteria for Male subjects with female partners of reproductive potential is outlined below: Male subjects with female partners of child bearing potential must comply with the following contraception requirements from the time of first dose of study medication until after the completion of the follow up visit. 1) Vasectomy with documentation of azoospermia. 2) Male condom plus partner use of one of the contraceptive options below: Contraceptive subdermal implant that meets GSK standard criteria including a \<1% rate of failure per year, as stated in the product label. Intrauterine device or intrauterine system that meets GSK standard criteria including a \<1% rate of failure per year, as stated in the product label. Oral Contraceptive, either combined or progestogen alone. Injectable progestogen. Contraceptive vaginal ring. Percutaneous contraceptive patches. These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
Exclusion criteria
* To avoid recruitment of subjects with a severe COPD exacerbation, the presence of any one of the following severity criteria will render the subject ineligible for inclusion in the study: Need for invasive mechanical ventilation (short term \[\<48 hour\] Non-invasive ventilation \[NIV\] or continuous positive airway pressure \[CPAP\] is acceptable); Haemodynamic instability or clinically significant heart failure; Confusion; Clinically significant pneumonia, identified by chest X-ray at screening, and as judged by the Investigator. * Subjects who have current medical conditions or diseases that are not well controlled and, which as judged by the Investigator, may affect subject safety or influence the outcome of the study. (Note: Patients with adequately treated and well controlled concurrent medical conditions (e.g. hypertension or noninsulin-dependent diabetes mellitus \[NIDDM\]) are permitted to be entered into the study). * Subject has a diagnosis of active tuberculosis, lung cancer, clinically overt bronchiectasis, pulmonary fibrosis, asthma or any other respiratory condition that might, in the opinion of the investigator, compromise the safety of the subject or affect the interpretation of the results. * ALT \>2xupper limit of normal (ULN) and bilirubin \>1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Baseline (Screening) and Days 12, 28 and 84 | Saline-induced sputum samples were collected at the indicated time-points to determine the alterations in previously identified immune cell mechanisms specifically related to neutrophil function by identifying the changes in mRNA transcriptome in induced sputum. Baseline was defined as screening visit. The log2 transformed mRNA intensities for each probe set were analyzed in a separate repeated measures model. Back transformed baseline-adjusted ratios and two-sided unadjusted p-values were calculated for each visit as the specified time-point value/baseline value. These ratios were converted to fold change values; if ratio \>= 1 then fold change=ratio or if ratio \< 1 then fold change = -1/ratio. Data for pre-specified probe sets that meet the criteria fold change \>1.5 or \<-1.5 and p\<0.05 for All NEMI, All Placebo and All NEMI/All Placebo group is presented in outcome measure 1, 2 and 3 respectively. In the categories column we have included time-point, Probe ID and Gene label. |
| Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Baseline (Screening) and Days 12, 28 and 84 | Saline-induced sputum samples were collected at the indicated time-points to determine the alterations in previously identified immune cell mechanisms specifically related to neutrophil function by identifying the changes in mRNA transcriptome in induced sputum. Baseline was defined as screening visit. The log2 transformed mRNA intensities for each probe set were analysed in a separate repeated measures model. Back transformed baseline-adjusted ratios and two-sided unadjusted p-values were calculated for each visit as the specified time-point value/baseline value. These ratios were converted to fold change values; if ratio \>= 1 then fold change=ratio or if ratio \< 1 then fold change = -1/ratio. Data for pre-specified probe sets that meet the criteria fold change \>1.5 or \<-1.5 and p\<0.05 for All NEMI, All Placebo and All NEMI/All Placebo group is presented in outcome measure 1, 2 and 3 respectively. In the categories column we have included time-point, Probe ID and Gene label. |
| Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Baseline (Screening) and Days 12, 28 and 84 | Saline-induced sputum samples were collected at the indicated time-points to determine the alterations in previously identified immune cell mechanisms specifically related to neutrophil function by identifying the changes in mRNA transcriptome in induced sputum. For each probe set, the log2 transformed mRNA intensities were analyzed in separate repeated measures models. The models included a Treatment, Visit and Treatment\*Visit term. The Visit consisted of 4 levels: Screening (Baseline), Day 12, Day 28 and Day 84, and the Treatment consisted of three levels: Null (when Visit = Screening), All Placebo and All NEMI. The fold changes were derived from the back transformed ratio from Baselines as fold change = ratio if ratio is \>=1, else if ratio \<1 then fold change = -1/ratio. Data for pre-specified probe sets that meet the criteria fold change \>1.5 and p\<0.05 for All NEMI, All Placebo and All NEMI/All Placebo group is presented in outcome measure 1, 2 and 3 respectively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28 | Baseline (Day 12) and Day 28 | siVaw is a measure of the volume in an individual's airway corrected for their lobar volume derived from the high resolution computed tomography (HRCT). It was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Baseline (Screening), Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For Untrimmed data and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only. |
| Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | Baseline (Screening) and Days 12 and 28 | iVaw was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Screening, Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For Untrimmed data and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (n=X1, X2 in the category title). This table presents the untrimmed data (in rows with categories containing untrimmed), SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only. |
| Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28 | Baseline (Day 12) and Day 28 | iVaw is a measure of the volume in an individual's airway derived from the HRCT. It was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Screening, Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For Untrimmed data and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only. |
| Change From Baseline in iVaw at FRC and TLC for Individual Regions | Baseline (Screening) and Days 12 and 28 | iVaw was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Screening, Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For Untrimmed data and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (n=X1, X2 in the category title). This table presents the untrimmed data (in rows with categories containing untrimmed), SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only. |
| Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28 | Baseline (Day 12) and Day 28 | iVaw is a measure of the volume in an individual's airway derived from the HRCT. It was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Screening, Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For Untrimmed data and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only. |
| Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | Baseline (Screening) and Days 12 and 28 | iRaw is a measure of the resistance in an individual's airway derived from HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). • This table presents the SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only. |
| Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28 | Baseline (Day 12) and Day 28 | iRaw is a measure of the resistance in an individual's airway derived from HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only. |
| Change From Baseline in iRaw at FRC and TLC for Individual Regions | Baseline (Screening) and Days 12 and 28 | iRaw is a measure of the resistance in an individual's airway derived from HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (n=X1, X2 in the category title). This table presents the SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only. |
| Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28 | Baseline (Day 12) and Day 28 | iRaw is a measure of the resistance in an individual's airway derived from HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only. |
| Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | Baseline (Screening) and Days 12 and 28 | siRaw is a measure of the resistance in an individual's airway corrected for their lobar volume derived from the HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analysed (represented by n=X1, X2 in the category title). This table presents the SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only. |
| Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28 | Baseline (Day 12) and Day 28 | siRaw is a measure of the resistance in an individual's airway corrected for their lobar volume derived from the HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analysed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only. |
| Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | Baseline (Screening) and Days 12 and 28 | siRaw is a measure of the resistance in an individual's airway corrected for their lobar volume derived from the HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analysed (represented by n=X1, X2 in the category title). This table presents the SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only. |
| Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28 | Baseline (Day 12) and Day 28 | siRaw is a measure of the resistance in an individual's airway corrected for their lobar volume derived from the HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analysed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only. |
| Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | Baseline (Screening), Days 12 and 28 | siVaw was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Baseline (Screening), Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For Untrimmed data and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (n=X1, X2 in the category title). This table presents the untrimmed data (in rows with categories containing untrimmed), SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only. |
| Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions | Baseline (Screening) and Days 12 and 28 | Change from Baseline in lung lobar volumes was measured at FRC and TLC scan conditions. Data was collected at longitudinal time points: Baseline (Screening), Day 12 and Day 28. At each time point it was measure at 5 Regions (Upper, Lower, Central, Distal & Total). The value at Screening was considered as Baseline. Change from Baseline is the post-Baseline value minus the Baseline value. The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI.There was no intent to compare two devices. |
| Change From Baseline in Trachea Length and Diameter at FRC and TLC | Baseline (Screening) and Days 12 and 28 | Trachea length and diameter was derived from HRCT. It was measured at both FRC and TLC scan conditions. The value at Screening was considered as Baseline. Change from Baseline is the post-Baseline value minus the Baseline value. The change from Baseline data is presented for Day 12 and Day 28 for trachea length and diameter. The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI.There was no intent to compare two devices. |
| Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Baseline and up to Day 84 | PEF measurements were taken (in triplicate) daily in the morning before dose administration, as soon as it is safe for the participant to do so. The best/highest result was recorded. Participants were provided with a handheld device. Baseline here is defined as average of Day 1 to Day 3. Change from Baseline is the post-Baseline value minus the Baseline value. The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI. There was no intent to compare two devices. |
| Mean Number of Occasions of Rescue Usage Per Day | Weeks 1 to 4; Weeks 5 to 8 and Weeks 9 to 12 | For reliever/rescue use, bronchodilator use recorded in the diary was summarized as the mean number of occasions of rescue use per day.where a rescue-free day was defined as a 24-hour period in which the number of occasions of bronchodilator use was zero. Number of occasions bronchodilator taken in the last 24 hours were collected in the daily diary. The mean number of occasions of rescue use per day, were calculated for each participant during the four weekly periods (Weeks 1 to 4; Weeks 5-8 and Weeks 9-12). The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI.There was no intent to compare two devices. |
| Mean Rescue Medication Free Days | Weeks 1 to 4; Weeks 5 to 8 and Weeks 9 to 12 | For reliever/rescue use, bronchodilator use recorded in the diary was summarized as the mean number of occasions of rescue use per day, where a rescue-free day was defined as a 24-hour period in which the number of occasions of bronchodilator use was zero. Number of occasions bronchodilator taken in the last 24 hours were collected in the daily diary. The mean number of rescue free days were calculated for each participant during the four weekly periods (Weeks 1 to 4; Weeks 5-8 and Weeks 9-12). The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI. There was no intent to compare two devices. |
| Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) | Baseline and Days 12, 28, 56, 84 | FEV1 is the volume of air that can forcibly be blown out in one second. A triplicate FEV1 measurement were taken daily in the morning before dose administration using the site's spirometer as soon as it was safe to do so. FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. Baseline is the latest available measurement from Day 2 Within 48 hours /discharge (On Treatment) and Day 1 (Pre-Treatment). Change from Baseline is the post-Baseline value minus Baseline value. The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI.There was no intent to compare two devices. |
| Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Baseline (Screening) and up to 14 weeks | Blood samples were collected to analyze the following s hematology parameters: Hemoglobin, Hematocrit, Mean Corpuscle Hemoglobin (MCH), Mean Corpuscle Volume (MCV), Platelet count, Red Blood Cell (RBC) count, White Blood Cell (WBC) count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils. Participants were counted in the worst case category that their value changes to (low or high), unless there is no change in their category. Participants whose lab value category was unchanged (example given \[e.g.\],High to High), or whose value became normal, were not recorded. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. The value at Screening was considered as Baseline. Data for Worst Case Laboratory Hematology values Post-Baseline Relative to Baseline has been presented. |
| Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Baseline (Screening) and up to 14 weeks | Blood samples were collected to analyze the following Chemistry parameters: Albumin, Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Direct Bilirubin, Total Bilirubin, Calcium, C-Reactive protein, Creatinine, Glucose, Potassium, Sodium, Total Protein and Urea/Blood urea nitrogen. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose lab value category was unchanged e.g. High to High), or whose value became normal, were not recorded. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. The value at Screening was considered as Baseline. Data for Worst Case Laboratory chemistry values Post-Baseline Relative to Baseline has been presented. |
| Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | Baseline (Screening) and up to 14 weeks | Vital signs were measured in semi-supine position after 5 minutes rest and included Systolic blood pressure (SBP), Diastolic blood pressure (DBP), Heart rate (HR). Data for number of participants with Post-Baseline worst case Vital Sign results relative to PCI Criteria relative to Baseline was presented. PCI ranges were: SBP (lower: \<85 and upper: \>160 mmHg), DBP (lower: \<45 and upper: \>100 mmHg), and HR (lower: \<40 and upper: \>110 bpm). The value at Screening was considered as Baseline. |
| Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Up to 14 weeks | A Single 12-lead ECGs was obtained at screening and at each other timepoint during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF) intervals. Data for number of participants with worst case post-Baseline abnormal ECG findings was reported. The value at Screening was considered as Baseline. |
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Up to 14 weeks | An AE is any untoward medical occurrence in a clinical investigation participant, or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward medical occurrence that at any dose, resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, is associated with liver injury and impaired liver function or any other situation according to medical or scientific judgment was categorized as SAE. Number of participants with AEs and SAEs have been reported. |
| Maximum Plasma Concentration (Cmax) Following Administration of NEMI | Day 1: 5 minutes Post-dose on Day 1 | Blood samples for pharmacokinetic (PK) analysis was collected at the indicated time points following administration of NEMI via DISKUS and ELLIPTA. |
| Trough Concentration Following Administration of NEMI | Day 1: 24 Hours post-dose; Days 12, 28, 56, 84: Pre-dose | Blood samples for pharmacokinetic (PK) analysis was collected at the indicated time points following administration of NEMI via DISKUS and ELLIPTA. |
| Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | Baseline (Screening) and Days 12 and 28 | Change from Baseline in lung lobar volumes was measured at FRC and TLC scan conditions. Data was collected at longitudinal time points: Baseline (Screening), Day 12 and Day 28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe). The value at Screening was considered as Baseline. Change from baseline is the post-Baseline value minus the Baseline value. The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI.There was no intent to compare two devices. |
| Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28 | Baseline (Day 12) and Day 28 | siVaw is a measure of the volume in an individual's airway corrected for their lobar volume derived from the high resolution computed tomography (HRCT). It was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Baseline (Screening), Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For Untrimmed data and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only. |
| Change From Baseline in siVaw at FRC and TLC for Individual Regions | Baseline (Screening), Days 12 and 28 | siVaw was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Baseline (Screening), Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For Untrimmed data and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (n=X1, X2 in the category title).This table presents the untrimmed data (in rows with categories containing untrimmed), SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only. |
Countries
Canada, Denmark
Participant flow
Recruitment details
A total 44 participants with Chronic obstructive pulmonary disease (COPD) were enrolled in this study. The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA.but the 2 treatment arms remained the same i.e. Placebo and GSK2269557 (Nemiralisib \[NEMI\]).There was no intent to compare two devices.
Pre-assignment details
As the switch to the ELLIPTA device was intended to be a comparable treatment, the treatment groups Placebo DISKUS and Placebo ELLIPTA were combined as All Placebo treatment group. Similarly, the treatment groups NEMI DISKUS and NEMI ELLIPTA were combined as All NEMI treatment group.
Participants by arm
| Arm | Count |
|---|---|
| All Placebo Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI). | 22 |
| All NEMI Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days | 22 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | All Placebo | All NEMI | Total |
|---|---|---|---|
| Age, Continuous | 64.0 Years STANDARD_DEVIATION 8.2 | 66.1 Years STANDARD_DEVIATION 7.32 | 65.1 Years STANDARD_DEVIATION 7.75 |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 22 Participants | 22 Participants | 44 Participants |
| Sex: Female, Male Female | 10 Participants | 11 Participants | 21 Participants |
| Sex: Female, Male Male | 12 Participants | 11 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 10 / 14 | 10 / 14 | 5 / 8 | 5 / 8 |
| serious Total, serious adverse events | 2 / 14 | 3 / 14 | 4 / 8 | 0 / 8 |
Outcome results
Primary
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Saline-induced sputum samples were collected at the indicated time-points to determine the alterations in previously identified immune cell mechanisms specifically related to neutrophil function by identifying the changes in mRNA transcriptome in induced sputum. For each probe set, the log2 transformed mRNA intensities were analyzed in separate repeated measures models. The models included a Treatment, Visit and Treatment\*Visit term. The Visit consisted of 4 levels: Screening (Baseline), Day 12, Day 28 and Day 84, and the Treatment consisted of three levels: Null (when Visit = Screening), All Placebo and All NEMI. The fold changes were derived from the back transformed ratio from Baselines as fold change = ratio if ratio is \>=1, else if ratio \<1 then fold change = -1/ratio. Data for pre-specified probe sets that meet the criteria fold change \>1.5 and p\<0.05 for All NEMI, All Placebo and All NEMI/All Placebo group is presented in outcome measure 1, 2 and 3 respectively.
Time frame: Baseline (Screening) and Days 12, 28 and 84
Population: All Subjects Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 12,200671_s_at,SPTBN1 | -1.74 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 12,226342_at,SPTBN1 | -1.89 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 12,200672_x_at,SPTBN1 | -1.60 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 12,209576_at,GNAI1 | -1.62 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 12,202178_at,PRKCZ | -1.55 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 28,244313_at,CR1 | 2.75 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 28,223750_s_at,TLR10 | 2.66 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 28,217552_x_at,CR1 | 2.25 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 28,206244_at,CR1 | 2.01 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 28,208488_s_at,CR1 | 1.95 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 28,232068_s_at,TLR4 | 1.71 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 28,1553297_a_at,CSF3R | 1.71 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 28,1552798_a_at,TLR4 | 1.68 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 28,223943_s_at,GNG2 | 1.63 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 28,221060_s_at,TLR4 | 1.58 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 28,239695_at,JAK1 | 1.52 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 28,234290_x_at,MYH14 | -1.52 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 28,1568377_x_at,DEFB124 | -1.52 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 28,1555765_a_at,GNG4 | -1.53 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 28,201464_x_at,JUN | -1.57 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 28,201465_s_at,JUN | -1.68 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 28,239381_at,KLK7 | -1.69 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 28,205778_at,KLK7 | -1.71 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 28,213281_at,JUN | -1.72 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 84,208304_at,CCR3 | 2.52 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 84,1553297_a_at,CSF3R | 2.25 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 84,203591_s_at,CSF3R | 1.98 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 84,221060_s_at,TLR4 | 1.83 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 84,202530_at,MAPK14 | 1.77 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 84,244313_at,CR1 | 1.60 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 84,203872_at,ACTA1 | 1.53 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 84,216944_s_at,ITPR1 | -1.51 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 84,215195_at,PRKCA | -1.66 Fold Change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group | Day 84,226498_at,FLT1 | -5.18 Fold Change |
Primary
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Saline-induced sputum samples were collected at the indicated time-points to determine the alterations in previously identified immune cell mechanisms specifically related to neutrophil function by identifying the changes in mRNA transcriptome in induced sputum. Baseline was defined as screening visit. The log2 transformed mRNA intensities for each probe set were analyzed in a separate repeated measures model. Back transformed baseline-adjusted ratios and two-sided unadjusted p-values were calculated for each visit as the specified time-point value/baseline value. These ratios were converted to fold change values; if ratio \>= 1 then fold change=ratio or if ratio \< 1 then fold change = -1/ratio. Data for pre-specified probe sets that meet the criteria fold change \>1.5 or \<-1.5 and p\<0.05 for All NEMI, All Placebo and All NEMI/All Placebo group is presented in outcome measure 1, 2 and 3 respectively. In the categories column we have included time-point, Probe ID and Gene label.
Time frame: Baseline (Screening) and Days 12, 28 and 84
Population: All Subjects Population comprised of all randomized participants who received at least one dose of the study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 12, 219748_at, TREML2 | -1.51 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 12, 204563_at, SELL | -1.87 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 12, 205118_at, FPR1 | -1.93 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 12, 236172_at, LTB4R | -1.96 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 12, 212372_at, MYH10 | -2.12 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 28, 244313_at, CR1 | 1.99 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 28, 213093_at, PRKCA | 1.53 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 28, 205778_at, KLK7 | -1.54 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 84, 233694_at, HSPA1L | 1.88 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 84, 208304_at, CCR3 | 1.83 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 84, 215101_s_at, CXCL5 | 1.82 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 84,214974_x_at ,CXCL5 | 1.80 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 84, 207852_at, CXCL5 | 1.63 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 84, 1555759_a_at, CCL5 | -1.51 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 84, 207535_s_at, NFKB2 | -1.53 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 84, 234212_at, ACTR2 | -1.57 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 84, 207794_at, CCR2 | -1.58 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 84, 206978_at, CCR2 | -1.64 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 84, 211889_x_at, CEACAM1 | -1.69 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 84, 206219_s_at, VAV1 | -1.71 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 84, 209498_at, CEACAM1 | -1.72 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 84, 206576_s_at, CEACAM1 | -1.75 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 84, 211883_x_at, CEACAM1 | -1.76 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 12,222834_s_at, GNG12 | 1.78 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 12,210390_s_at, CCL15 | 1.72 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 12,212294_at, GNG12 | 1.67 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 12,226497_s_at, FLT1 | 1.57 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 12, 204356_at, LIMK1 | 1.54 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 12, 203923_s_at, CYBB | 1.51 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 12, 1555086_at, STAT5B | -1.51 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 12, 211883_x_at, CEACAM1 | -1.51 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 12, 224909_s_at, PREX1 | -1.51 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 12, 239170_at, ACTR3 | -1.51 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 12, 212550_at, STAT5B | -1.52 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 12, 202178_at, PRKCZ | -1.52 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 12, 219633_at, TTPAL | -1.53 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 12, 204285_s_at, PMAIP1 | -1.56 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 12, 1555088_x_at, STAT5B | -1.56 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 12, 227817_at, PRKCB | -1.57 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 12, 205632_s_at, PIP5K1B | -1.58 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 12, 202018_s_at, LTF | -1.59 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 12, 232763_at, TLN1 | -1.59 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 12, 202948_at, IL1R1 | -1.60 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 12, 1569830_at, PTPRC | -1.63 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 12, 215561_s_at, IL1R1 | -1.69 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 12, 228031_at, TTPAL | -1.71 Fold change |
| All NEMI | Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group | Day 12, 209498_at, CEACAM1 | -1.75 Fold change |
Primary
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Saline-induced sputum samples were collected at the indicated time-points to determine the alterations in previously identified immune cell mechanisms specifically related to neutrophil function by identifying the changes in mRNA transcriptome in induced sputum. Baseline was defined as screening visit. The log2 transformed mRNA intensities for each probe set were analysed in a separate repeated measures model. Back transformed baseline-adjusted ratios and two-sided unadjusted p-values were calculated for each visit as the specified time-point value/baseline value. These ratios were converted to fold change values; if ratio \>= 1 then fold change=ratio or if ratio \< 1 then fold change = -1/ratio. Data for pre-specified probe sets that meet the criteria fold change \>1.5 or \<-1.5 and p\<0.05 for All NEMI, All Placebo and All NEMI/All Placebo group is presented in outcome measure 1, 2 and 3 respectively. In the categories column we have included time-point, Probe ID and Gene label.
Time frame: Baseline (Screening) and Days 12, 28 and 84
Population: All Subjects Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12, 222834_s_at, GNG12 | 2.29 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12, 207852_at, CXCL5 | 1.81 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12, 212294_at, GNG12 | 1.79 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12, 209576_at, GNAI1 | 1.61 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12, 201783_s_at, RELA | -1.50 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12, 213281_at, JUN | 1.51 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12, 222880_at, AKT3 | 1.51 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12, 205026_at, STAT5B | -1.50 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12, 227404_s_at, EGR1 | -1.51 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12, 1552552_s_at,CLEC4C | -1.54 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12, 211823_s_at,PXN | -1.55 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12,206978_at,CCR2 | -1.55 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12,206219_s_at,VAV1 | -1.56 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12,219748_at,TREML2 | -1.56 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12,207794_at,CCR2 | -1.58 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12,211561_x_at,MAPK14 | -1.59 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12,226507_at,PAK1 | -1.59 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12,232068_s_at,TLR4 | -1.60 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12,209282_at,PRKD2 | -1.60 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12,226080_at,SSH2 | -1.61 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12,212550_at,STAT5B | -1.64 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12,212372_at,MYH10 | -1.64 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12,214022_s_at,IFITM1 | -1.66 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12,217484_at,CR1 | -1.67 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12,206244_at,CR1 | -1.68 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12,1552480_s_at,PTPRC | -1.68 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12,1554114_s_at,SSH2 | -1.69 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12,201601_x_at,IFITM1 | -1.75 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12,205842_s_at,JAK2 | -1.75 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12,228603_at, ACTR3 | -1.75 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12,230100_x_at,PAK1 | -1.77 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12,239307_at,MYH11 | -1.88 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12,223750_s_at,TLR10 | -1.88 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12,208488_s_at,CR1 | -1.92 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 12,204563_at,SELL | -2.70 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 28, 222834_s_at,GNG12 | 1.91 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 84,226498_at,FLT1 | 4.10 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 84,216598_s_at,CCL2 | 1.75 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 84,1562439_at,NCOA3 | 1.52 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 84,201087_at,PXN | -1.52 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 84,224909_s_at,PREX1 | -1.52 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 84,211823_s_at,PXN | -1.53 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 84,209615_s_at,PAK1 | -1.54 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 84,211561_x_at,MAPK14 | -1.59 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 84,203749_s_at,RARA | -1.60 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 84,219748_at,TREML2 | -1.61 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 84,207008_at,CXCR2 | -1.66 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 84,244313_at,CR1 | -1.67 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 84,202530_at,MAPK14 | -1.69 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 84,228648_at,LRG1 | -1.71 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 84,208488_s_at,CR1 | -1.71 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 84,228795_at,PRKCB | -1.73 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 84,1552480_s_at,PTPRC | -1.76 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 84,232068_s_at,TLR4 | -1.77 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 84,221060_s_at,TLR4 | -1.78 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 84,201601_x_at,IFITM1 | -1.79 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 84,202018_s_at,LTF | -1.82 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 84,217209_at,CEACAM3 | -1.85 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 84,214022_s_at,IFITM1 | -1.89 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 84,217552_x_at,CR1 | -1.89 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 84,203591_s_at,CSF3R | -1.91 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 84,205118_at,FPR1 | -1.92 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 84,1553297_a_at,CSF3R | -1.96 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 84,204563_at,SELL | -2.23 Fold Change |
| All NEMI | Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group | Day 84,219669_at,CD177 | -2.47 Fold Change |
Secondary
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
PEF measurements were taken (in triplicate) daily in the morning before dose administration, as soon as it is safe for the participant to do so. The best/highest result was recorded. Participants were provided with a handheld device. Baseline here is defined as average of Day 1 to Day 3. Change from Baseline is the post-Baseline value minus the Baseline value. The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI. There was no intent to compare two devices.
Time frame: Baseline and up to Day 84
Population: All Subjects Population.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 15 | 17.7 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 21 | 20.1 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 31 | 9.5 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 61 | 18.9 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 80 | 18.1 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 58 | 14.2 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 57 | 16.2 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 59 | 15.1 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 60 | 16.4 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 4 | 2.5 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 5 | -3.0 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 6 | 7.3 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 62 | 16.9 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 8 | 0.8 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 9 | 10.0 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 10 | 12.9 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 11 | 14.1 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 12 | 6.2 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 13 | 21.0 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 14 | 9.4 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 7 | 8.1 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 16 | 14.1 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 17 | 17.6 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 18 | 11.8 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 19 | 12.9 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 20 | 6.4 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 22 | 10.7 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 23 | 16.0 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 24 | 19.0 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 25 | 23.8 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 26 | 20.8 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 27 | 29.1 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 28 | 19.3 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 29 | 20.8 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 30 | 9.5 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 32 | 5.9 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 33 | 9.5 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 34 | 6.4 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 35 | 17.0 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 36 | 16.7 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 37 | 13.4 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 38 | 12.6 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 39 | 13.4 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 63 | 22.4 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 64 | 7.9 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 65 | 12.9 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 66 | 10.0 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 67 | 12.7 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 68 | 14.3 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 69 | 11.9 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 70 | 10.8 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 71 | 7.9 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 72 | 7.9 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 73 | 3.2 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 74 | 6.2 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 75 | 7.13 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 76 | 12.1 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 77 | 12.3 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 78 | 10.4 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 79 | 21.2 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 81 | 7.3 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 82 | 5.6 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 83 | 21.1 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 84 | 12.9 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 40 | 13.7 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 41 | 16.7 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 42 | 16.7 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 43 | 16.4 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 44 | 12.6 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 45 | 14.5 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 46 | 9.7 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 47 | 12.3 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 48 | 13.4 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 49 | 14.5 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 50 | 20.1 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 51 | 18.9 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 52 | 14.5 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 53 | 8.9 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 54 | 10.6 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 55 | 21.0 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 56 | 12.5 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 36 | 3 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 46 | 5 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 37 | 9.2 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 41 | 8 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 42 | 10.2 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 81 | 7 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 61 | 5.7 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 63 | 7.2 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 70 | 11.2 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 38 | 5.5 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 54 | 14.4 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 62 | 10.2 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 57 | 32.3 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 58 | 10.4 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 82 | 10 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 59 | 11.2 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 47 | 7.2 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 60 | 1.2 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 64 | 9.5 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 4 | 4.1 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 83 | 13.0 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 5 | 6.3 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 65 | 15 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 6 | 7.5 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 52 | 21.5 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 7 | 11.3 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 66 | 10 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 8 | 8.2 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 84 | 11.6 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 9 | 17.7 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 67 | 15.2 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 10 | 15.2 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 39 | 9.5 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 11 | 21.1 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 68 | 11 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 12 | 20.4 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 48 | 6.2 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 13 | 18.8 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 69 | 11.5 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 14 | 15.3 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 40 | 10 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 15 | 10.8 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 56 | 26.5 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 16 | 12.5 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 71 | 11 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 17 | 11.5 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 49 | 12.8 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 18 | 11.9 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 72 | 14.9 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 19 | 7.1 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 53 | 17.3 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 20 | 3.3 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 21 | 4.1 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 73 | 14.3 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 22 | 6.2 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 43 | 15 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 23 | 2.8 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 74 | 10.7 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 24 | 6.9 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 50 | 9.7 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 25 | 11.6 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 75 | 13 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 26 | 14.4 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 44 | 9.5 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 27 | 17.6 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 76 | 11.2 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 28 | 11.2 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 55 | 18.7 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 29 | 13.8 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 77 | 16.5 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 30 | 17.2 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 31 | 11.5 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 45 | 7.5 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 32 | 17.2 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 78 | 12 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 33 | 7.3 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 51 | 13.2 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 34 | 6 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 79 | 9.7 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 35 | 7 Liters per minute |
| All NEMI | Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF) | Day 80 | 10 Liters per minute |
Secondary
Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28
iRaw is a measure of the resistance in an individual's airway derived from HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only.
Time frame: Baseline (Day 12) and Day 28
Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Right Upper,Day 28,n=16,18 | 1.082 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28 | TLC,Scan Trimmed,Right Upper,Day 28,n=17,19 | 1.133 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Right Lower,Day 28,n=16,18 | 1.269 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28 | TLC,Scan Trimmed,Left Upper,Day 28,n=17,19 | 1.000 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Right Middle,Day 28,n=16,18 | 1.149 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28 | TLC,Scan Trimmed,Right Middle,Day 28,n=17,19 | 1.971 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28 | TLC,Scan Trimmed,Right Lower,Day 28,n=17,19 | 1.408 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Left Lower,Day 28,n=16,18 | 1.768 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28 | TLC,Scan Trimmed,Left Lower,Day 28,n=17,19 | 1.486 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Left Upper,Day 28,n=16,18 | 1.266 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28 | TLC,Scan Trimmed,Left Lower,Day 28,n=17,19 | 1.056 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28 | TLC,Scan Trimmed,Right Middle,Day 28,n=17,19 | 1.537 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Right Upper,Day 28,n=16,18 | 1.152 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Left Upper,Day 28,n=16,18 | 1.008 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Right Middle,Day 28,n=16,18 | 1.477 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Right Lower,Day 28,n=16,18 | 1.276 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Left Lower,Day 28,n=16,18 | 1.185 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28 | TLC,Scan Trimmed,Right Upper,Day 28,n=17,19 | 1.143 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28 | TLC,Scan Trimmed,Left Upper,Day 28,n=17,19 | 1.093 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28 | TLC,Scan Trimmed,Right Lower,Day 28,n=17,19 | 1.073 kPa*s/L |
Secondary
Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28
iRaw is a measure of the resistance in an individual's airway derived from HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only.
Time frame: Baseline (Day 12) and Day 28
Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Upper,Day 28,n=16,18 | 1.221 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Lower,Day 28,n=16,18 | 1.531 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Central,Day 28,n=16,18 | 0.989 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Distal,Day 28,n=16,18 | 1.373 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Total,Day 28,n=16,18 | 1.157 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Upper,Day 28,n=17,19 | 1.473 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Lower,Day 28,n=17,19 | 1.422 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Central,Day 28,n=17,19 | 0.986 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Distal,Day 28,n=17,19 | 1.712 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Total,Day 28,n=17,19 | 1.321 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Central,Day 28,n=17,19 | 1.044 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Upper,Day 28,n=16,18 | 1.266 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Upper,Day 28,n=17,19 | 1.172 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Lower,Day 28,n=16,18 | 1.278 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Total,Day 28,n=17,19 | 1.085 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Central,Day 28,n=16,18 | 0.926 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Lower,Day 28,n=17,19 | 1.089 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Distal,Day 28,n=16,18 | 1.235 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Distal,Day 28,n=17,19 | 1.079 kPa*s/L |
| All NEMI | Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Total,Day 28,n=16,18 | 1.001 kPa*s/L |
Secondary
Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28
iVaw is a measure of the volume in an individual's airway derived from the HRCT. It was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Screening, Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For Untrimmed data and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only.
Time frame: Baseline (Day 12) and Day 28
Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Right Upper,Day 28,n=16,18 | 0.995 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Left Upper,Day 28,n=16,18 | 0.973 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Right Middle,Day 28,n=16,18 | 0.958 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Right Lower,Day 28,n=16,18 | 0.918 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Left Lower,Day 28,n=16,18 | 0.943 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28 | TLC,Scan Trimmed,Right Upper,Day 28,n=17,19 | 0.963 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28 | TLC,Scan Trimmed,Left Upper,Day 28,n=17,19 | 0.976 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28 | TLC,Right Middle,Day 28,n=17,19 | 0.784 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28 | TLC,Scan Trimmed,Right Lower,Day 28,n=17,19 | 0.926 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28 | TLC,Scan Trimmed,Left Lower,Day 28,n=17,19 | 0.928 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28 | TLC,Right Middle,Day 28,n=17,19 | 0.904 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Right Upper,Day 28,n=16,18 | 0.977 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28 | TLC,Scan Trimmed,Right Upper,Day 28,n=17,19 | 0.966 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Left Upper,Day 28,n=16,18 | 1.016 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28 | TLC,Scan Trimmed,Left Lower,Day 28,n=17,19 | 0.951 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Right Middle,Day 28,n=16,18 | 0.943 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28 | TLC,Scan Trimmed,Left Upper,Day 28,n=17,19 | 0.996 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Right Lower,Day 28,n=16,18 | 1.008 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28 | TLC,Scan Trimmed,Right Lower,Day 28,n=17,19 | 0.935 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Left Lower,Day 28,n=16,18 | 1.024 Milliliters |
Secondary
Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28
iVaw is a measure of the volume in an individual's airway derived from the HRCT. It was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Screening, Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For Untrimmed data and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only.
Time frame: Baseline (Day 12) and Day 28
Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Upper,Day 28,n=16,18 | 0.988 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Lower,Day 28,n=16,18 | 0.934 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Central,Day 28,n=16,18 | 0.985 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Distal,Day 28,n=16,18 | 0.966 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Total,Day 28,n=16,18 | 0.985 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Upper,Day 28,n=17,19 | 0.968 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Lower,Day 28,n=17,19 | 0.933 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Central,Day 28,n=17,19 | 0.996 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Distal,Day 28,n=17,19 | 0.954 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Total,Day 28,n=17,19 | 0.989 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Central,Day 28,n=17,19 | 0.972 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Upper,Day 28,n=16,18 | 0.985 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Upper,Day 28,n=17,19 | 0.968 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Lower,Day 28,n=16,18 | 1.010 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Total,Day 28,n=17,19 | 0.966 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Central,Day 28,n=16,18 | 1.008 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Lower,Day 28,n=17,19 | 0.942 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Distal,Day 28,n=16,18 | 0.990 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Distal,Day 28,n=17,19 | 0.954 Milliliters |
| All NEMI | Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Total,Day 28,n=16,18 | 1.006 Milliliters |
Secondary
Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28
siVaw is a measure of the volume in an individual's airway corrected for their lobar volume derived from the high resolution computed tomography (HRCT). It was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Baseline (Screening), Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For Untrimmed data and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only.
Time frame: Baseline (Day 12) and Day 28
Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Right Upper,Day 28,n=16,17 | 0.998 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Left Upper,Day 28,n=16,18 | 0.987 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Right Middle,Day 28,n=16,17 | 1.003 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Right Lower,Day 28,n=16,18 | 0.938 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Left Lower,Day 28,n=16,18 | 0.947 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28 | TLC, Scan Trimmed,Right Upper,Day 28,n=17,18 | 0.963 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28 | TLC, Scan Trimmed,Left Upper,Day 28,n=17,19 | 0.984 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28 | TLC, Scan Trimmed,Right Middle,Day 28,n=17,18 | 0.807 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28 | TLC, Scan Trimmed,Right Lower,Day 28,n=17,19 | 0.945 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28 | TLC, Scan Trimmed,Left Lower,Day 28,n=17,19 | 0.950 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28 | TLC, Scan Trimmed,Right Middle,Day 28,n=17,18 | 0.897 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Right Upper,Day 28,n=16,17 | 0.988 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28 | TLC, Scan Trimmed,Right Upper,Day 28,n=17,18 | 0.965 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Left Upper,Day 28,n=16,18 | 1.014 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28 | TLC, Scan Trimmed,Left Lower,Day 28,n=17,19 | 0.963 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Right Middle,Day 28,n=16,17 | 0.930 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28 | TLC, Scan Trimmed,Left Upper,Day 28,n=17,19 | 0.999 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Right Lower,Day 28,n=16,18 | 1.020 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28 | TLC, Scan Trimmed,Right Lower,Day 28,n=17,19 | 0.943 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Left Lower,Day 28,n=16,18 | 1.042 Milliliters per Liter |
Secondary
Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28
siVaw is a measure of the volume in an individual's airway corrected for their lobar volume derived from the high resolution computed tomography (HRCT). It was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Baseline (Screening), Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For Untrimmed data and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only.
Time frame: Baseline (Day 12) and Day 28
Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Upper,Day 28,n=16,18 | 0.996 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Lower,Day 28,n=16,18 | 0.948 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Central,Day 28,n=16,18 | 0.997 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Distal,Day 28,n=16,18 | 0.977 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Total,Day 28,n=16, 18 | 0.997 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Upper,Day 28,n=17,19 | 0.973 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Lower,Day 28,n=17, 19 | 0.954 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Central,Day 28,n=17,19 | 1.009 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Distal,Day 28,n=17,19 | 0.967 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Total,Day 28,n=17,19 | 1.003 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Central,Day 28,n=17,19 | 0.977 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Upper,Day 28,n=16,18 | 0.986 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Upper,Day 28,n=17,19 | 0.970 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Lower,Day 28,n=16,18 | 1.025 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Total,Day 28,n=17,19 | 0.972 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Central,Day 28,n=16,18 | 1.014 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Lower,Day 28,n=17, 19 | 0.952 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Distal,Day 28,n=16,18 | 0.996 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Distal,Day 28,n=17,19 | 0.960 Milliliters per Liter |
| All NEMI | Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Total,Day 28,n=16, 18 | 1.012 Milliliters per Liter |
Secondary
Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28
siRaw is a measure of the resistance in an individual's airway corrected for their lobar volume derived from the HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analysed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only.
Time frame: Baseline (Day 12) and Day 28
Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Right Middle,Day 28,n=16,17 | 1.097 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28 | TLC,Scan Trimmed,Right Upper,Day 28,n=17,18 | 1.132 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Left Upper,Day 28,n=16,18 | 1.249 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28 | TLC,Scan Trimmed,Left Upper,Day 28,n=17,19 | 0.992 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Right Lower,Day 28,n=16,18 | 1.241 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28 | TLC,Scan Trimmed,Right Middle,Day 28,n=17,18 | 1.915 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Right Upper,Day 28,n=16,17 | 1.079 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28 | TLC,Scan Trimmed,Right Lower,Day 28,n=17,19 | 1.380 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Left Lower,Day 28,n=16,18 | 1.760 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28 | TLC,Scan Trimmed,Left Lower,Day 28,n=17,19 | 1.453 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Left Lower,Day 28,n=16,18 | 1.165 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Right Upper,Day 28,n=16,17 | 1.073 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Left Upper,Day 28,n=16,18 | 1.011 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Right Middle,Day 28,n=16,17 | 1.354 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28 | FRC,Scan Trimmed,Right Lower,Day 28,n=16,18 | 1.261 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28 | TLC,Scan Trimmed,Left Lower,Day 28,n=17,19 | 1.042 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28 | TLC,Scan Trimmed,Right Upper,Day 28,n=17,18 | 1.142 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28 | TLC,Scan Trimmed,Left Upper,Day 28,n=17,19 | 1.089 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28 | TLC,Scan Trimmed,Right Middle,Day 28,n=17,18 | 1.564 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28 | TLC,Scan Trimmed,Right Lower,Day 28,n=17,19 | 1.064 kPa*s |
Secondary
Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28
siRaw is a measure of the resistance in an individual's airway corrected for their lobar volume derived from the HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analysed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only.
Time frame: Baseline (Day 12) and Day 28
Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Upper,Day 28,n=16,18 | 1.211 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Lower,Day 28,n=16,18 | 1.508 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Central,Day 28,n=16,18 | 0.977 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Distal,Day 28,n=16,18 | 1.356 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Total,Day 28,n=16,18 | 1.144 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Upper,Day 28,n=17,19 | 1.465 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Lower,Day 28,n=17,19 | 1.392 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Central,Day 28,n=17,19 | 0.973 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Distal,Day 28,n=17,19 | 1.689 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Total,Day 28,n=17,19 | 1.303 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Central,Day 28,n=17,19 | 1.038 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Upper,Day 28,n=16,18 | 1.265 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Upper,Day 28,n=17,19 | 1.169 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Lower,Day 28,n=16,18 | 1.260 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Total,Day 28,n=17,19 | 1.079 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Central,Day 28,n=16,18 | 0.921 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Lower,Day 28,n=17,19 | 1.079 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Distal,Day 28,n=16,18 | 1.227 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28 | TLC,Scan Trimmed,Distal,Day 28,n=17,19 | 1.073 kPa*s |
| All NEMI | Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28 | FRC,Scan Trimmed,Total,Day 28,n=16,18 | 0.995 kPa*s |
Secondary
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC)
FEV1 is the volume of air that can forcibly be blown out in one second. A triplicate FEV1 measurement were taken daily in the morning before dose administration using the site's spirometer as soon as it was safe to do so. FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. Baseline is the latest available measurement from Day 2 Within 48 hours /discharge (On Treatment) and Day 1 (Pre-Treatment). Change from Baseline is the post-Baseline value minus Baseline value. The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI.There was no intent to compare two devices.
Time frame: Baseline and Days 12, 28, 56, 84
Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All NEMI | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) | FEV1,Day 12,n=20,18 | -0.001 Liters | Standard Deviation 0.1681 |
| All NEMI | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) | FEV1,Day 28,n=19,20 | 0.005 Liters | Standard Deviation 0.2227 |
| All NEMI | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) | FEV1,Day 56,n=19,20 | -0.014 Liters | Standard Deviation 0.1783 |
| All NEMI | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) | FEV1,Day 84,n=17,20 | -0.029 Liters | Standard Deviation 0.1281 |
| All NEMI | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) | FVC,Day 12,n=20,18 | -0.024 Liters | Standard Deviation 0.4723 |
| All NEMI | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) | FVC,Day 28,n=19,20 | 0.024 Liters | Standard Deviation 0.4159 |
| All NEMI | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) | FVC,Day 56,n=19,20 | -0.078 Liters | Standard Deviation 0.4106 |
| All NEMI | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) | FVC,Day 84,n=17,20 | -0.104 Liters | Standard Deviation 0.3786 |
| All NEMI | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) | FVC,Day 84,n=17,20 | 0.123 Liters | Standard Deviation 0.4579 |
| All NEMI | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) | FEV1,Day 12,n=20,18 | 0.084 Liters | Standard Deviation 0.1879 |
| All NEMI | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) | FVC,Day 12,n=20,18 | 0.062 Liters | Standard Deviation 0.377 |
| All NEMI | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) | FEV1,Day 28,n=19,20 | 0.094 Liters | Standard Deviation 0.2035 |
| All NEMI | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) | FVC,Day 56,n=19,20 | 0.212 Liters | Standard Deviation 0.4827 |
| All NEMI | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) | FEV1,Day 56,n=19,20 | 0.112 Liters | Standard Deviation 0.2613 |
| All NEMI | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) | FVC,Day 28,n=19,20 | 0.231 Liters | Standard Deviation 0.427 |
| All NEMI | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) | FEV1,Day 84,n=17,20 | 0.077 Liters | Standard Deviation 0.2747 |
Secondary
Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes
iRaw is a measure of the resistance in an individual's airway derived from HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). • This table presents the SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only.
Time frame: Baseline (Screening) and Days 12 and 28
Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Right Upper,Day 28,n=16,19 | 1.213 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Left Lower,Day 28,n=16,19 | 1.576 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Right Middle,Day 12,n=18,17 | 0.559 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Upper,Day 12,n=20,18 | 1.058 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Right Upper,Day 12,n=18,17 | 1.129 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Upper,Day 28,n=18,20 | 1.307 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Right Middle,Day 28,n=16,19 | 1.420 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Left Upper,Day 12,n=20,18 | 1.129 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Left Upper,Day 12,n=18,17 | 1.058 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Left Upper,Day 28,n=18,20 | 1.212 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Right Lower,Day 12,n=17,17 | 0.903 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Middle,Day 12,n=19,18 | 1.190 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Left Lower,Day 28,n=18,20 | 1.259 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Middle,Day 28,n=18,20 | 1.749 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Right Lower,Day 28,n=16,19 | 0.681 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Lower,Day 12,n=20,18 | 0.727 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Left Upper,Day 28,n=16,19 | 1.151 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Lower,Day 28,n=18,20 | 1.143 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Left Lower,Day 12,n=17,17 | 1.084 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Left Lower,Day 12,n=20,18 | 1.003 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Left Lower,Day 12,n=17,17 | 0.902 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Left Lower,Day 28,n=18,20 | 1.213 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Right Upper,Day 12,n=18,17 | 0.876 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Right Upper,Day 28,n=16,19 | 0.884 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Left Upper,Day 12,n=18,17 | 0.951 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Left Upper,Day 28,n=16,19 | 0.681 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Right Middle,Day 12,n=18,17 | 0.970 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Right Middle,Day 28,n=16,19 | 1.275 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Right Lower,Day 12,n=17,17 | 1.149 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Right Lower,Day 28,n=16,19 | 0.935 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Left Lower,Day 12,n=20,18 | 1.144 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Left Lower,Day 28,n=16,19 | 0.904 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Upper,Day 12,n=20,18 | 1.057 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Upper,Day 28,n=18,20 | 1.292 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Left Upper,Day 12,n=20,18 | 1.075 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Left Upper,Day 28,n=18,20 | 1.160 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Middle,Day 12,n=19,18 | 1.148 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Middle,Day 28,n=18,20 | 1.583 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Lower,Day 12,n=20,18 | 1.325 Kilopascal* seconds per liter (kPa*s/L) |
| All NEMI | Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Lower,Day 28,n=18,20 | 1.463 Kilopascal* seconds per liter (kPa*s/L) |
Secondary
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
iVaw was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Screening, Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For Untrimmed data and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (n=X1, X2 in the category title). This table presents the untrimmed data (in rows with categories containing untrimmed), SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only.
Time frame: Baseline (Screening) and Days 12 and 28
Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Upper,Day 12,n=20,18 | 0.976 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Right Upper,Day 28,n=16,19 | 1.016 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Left Upper,Day 12,n=18,17 | 0.965 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Left Upper,Day 28,n=16,19 | 0.998 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Right Middle,Day 12,n=18,17 | 1.129 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Right Middle,Day 28,n=16,19 | 0.950 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Right Lower,Day 12,n=17,17 | 1.046 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Right Lower,Day 28,n=16,19 | 1.042 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Left Lower,Day 12,n=17,17 | 1.003 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Left Lower,Day 28,n=16,19 | 0.971 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Right Upper,Day 12,n=18,17 | 1.007 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Upper,Day 28,n=18,20 | 0.941 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Left Upper,Day 12,n=20,18 | 0.957 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Left Upper,Day 28,n=18,20 | 0.928 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Middle,Day 12,n=19,18 | 0.882 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Middle,Day 28,n=18,20 | 0.873 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Lower,Day 12,n=20,18 | 1.083 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Lower,Day 28,n=18,20 | 0.967 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Left Lower,Day 12,n=20,18 | 0.981 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Left Lower,Day 28,n=18,20 | 0.939 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Untrimmed,Right Upper,Day 12,n= 18,17 | 0.886 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Untrimmed,Right Upper, Day 28,n=16,19 | 0.990 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Untrimmed,Left Upper, Day 12,n=18,17 | 0.996 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Untrimmed,Left Upper, Day 28,n=16,19 | 1.071 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Untrimmed,Right Middle, Day 12,n=18,17 | 1.167 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Untrimmed,Right Middle, Day 28,n=16,19 | 0.991 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Untrimmed,Right Lower, Day 12,n=17,17 | 1.262 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Untrimmed,Right Lower, Day 28,n=16,19 | 1.253 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Untrimmed,Left Lower, Day 12,n=17,17 | 0.959 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Untrimmed,Left Lower, Day 28,n=16,19 | 0.813 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Untrimmed,Right Upper,Day 12,n=20,18 | 0.960 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Untrimmed,Right Upper, Day 28,n=18,20 | 0.874 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Untrimmed,Left Upper, Day 12,n=20,18 | 0.958 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Untrimmed,Left Upper, Day 28,n=18,20 | 0.942 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Untrimmed,Right Middle, Day 12,n=19,18 | 0.872 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Untrimmed,Right Middle, Day 28,n=18,20 | 0.622 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Untrimmed,Right Lower, Day 12,n=20,18 | 1.162 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Untrimmed,Right Lower, Day 28,n=18,20 | 0.963 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Untrimmed,Left Lower, Day 12,n=20,18 | 0.996 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Untrimmed,Left Lower, Day 28,n=18,20 | 0.881 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Untrimmed,Right Lower, Day 28,n=18,20 | 0.843 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Right Upper,Day 12,n=18,17 | 1.044 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Untrimmed,Right Upper,Day 12,n= 18,17 | 1.095 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Right Upper,Day 28,n=16,19 | 1.037 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Untrimmed,Right Upper,Day 12,n=20,18 | 0.984 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Left Upper,Day 12,n=18,17 | 0.987 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Untrimmed,Right Upper, Day 28,n=16,19 | 1.083 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Left Upper,Day 28,n=16,19 | 1.062 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Untrimmed,Right Middle, Day 28,n=18,20 | 0.886 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Right Middle,Day 12,n=18,17 | 1.014 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Untrimmed,Left Upper, Day 12,n=18,17 | 0.950 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Right Middle,Day 28,n=16,19 | 1.018 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Untrimmed,Right Upper, Day 28,n=18,20 | 0.923 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Right Lower,Day 12,n=17,17 | 1.005 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Untrimmed,Left Upper, Day 28,n=16,19 | 1.074 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Right Lower,Day 28,n=16,19 | 1.025 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Untrimmed,Left Lower, Day 28,n=18,20 | 0.940 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Left Lower,Day 12,n=17,17 | 1.010 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Untrimmed,Right Middle, Day 12,n=18,17 | 1.157 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Left Lower,Day 28,n=16,19 | 1.029 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Untrimmed,Left Upper, Day 12,n=20,18 | 0.932 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Upper,Day 12,n=20,18 | 0.982 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Untrimmed,Right Middle, Day 28,n=16,19 | 1.155 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Upper,Day 28,n=18,20 | 0.946 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Untrimmed,Right Lower, Day 12,n=20,18 | 0.871 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Left Upper,Day 12,n=20,18 | 0.958 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Untrimmed,Right Lower, Day 12,n=17,17 | 0.990 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Left Upper,Day 28,n=18,20 | 0.938 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Untrimmed,Left Upper, Day 28,n=18,20 | 0.914 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Middle,Day 12,n=19,18 | 0.988 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Untrimmed,Right Lower, Day 28,n=16,19 | 1.014 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Middle,Day 28,n=18,20 | 0.895 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Untrimmed,Left Lower, Day 12,n=20,18 | 0.967 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Lower,Day 12,n=20,18 | 0.937 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Untrimmed,Left Lower, Day 12,n=17,17 | 0.981 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Lower,Day 28,n=18,20 | 0.877 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Untrimmed,Right Middle, Day 12,n=19,18 | 0.952 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Left Lower,Day 12,n=20,18 | 0.981 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | FRC,Untrimmed,Left Lower, Day 28,n=16,19 | 1.107 Milliliters |
| All NEMI | Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Left Lower,Day 28,n=18,20 | 0.923 Milliliters |
Secondary
Change From Baseline in iRaw at FRC and TLC for Individual Regions
iRaw is a measure of the resistance in an individual's airway derived from HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (n=X1, X2 in the category title). This table presents the SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only.
Time frame: Baseline (Screening) and Days 12 and 28
Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Lower,Day 28,n=16,19 | 1.071 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Upper,Day 12,n=18,17 | 0.827 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Upper,Day 28,n=16,19 | 1.395 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Lower,Day 12,n=17,17 | 1.112 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Central,Day 12,n=18,17 | 0.932 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Central,Day 28,n=16,19 | 0.876 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Distal,Day 12,n=18,17 | 1.001 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Distal,Day 28,n=16,19 | 1.169 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Total,Day 12,n=18,17 | 0.985 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Total,Day 28,n=16,19 | 1.045 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Upper,Day 12,n=20,18 | 1.142 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Upper,Day 28,n=18,20 | 1.540 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Lower,Day 12,n=20,18 | 0.860 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Lower,Day 28,n=18,20 | 1.142 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Central,Day 12,n=20,18 | 0.987 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Central,Day 28,n=18,20 | 0.985 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Distal,Day 12,n=20,18 | 0.959 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Distal,Day 28,n=18,20 | 1.332 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Total,Day 12,n=20,18 | 0.993 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Total,Day 28,n=18,20 | 1.196 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Distal,Day 28,n=18,20 | 1.288 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Upper,Day 12,n=20,18 | 1.167 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Upper,Day 12,n=18,17 | 0.831 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Central,Day 28,n=18,20 | 1.057 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Upper,Day 28,n=16,19 | 0.776 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Upper,Day 28,n=18,20 | 1.271 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Lower,Day 12,n=17,17 | 1.066 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Lower,Day 28,n=16,19 | 0.912 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Total,Day 28,n=18,20 | 1.202 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Central,Day 12,n=18,17 | 0.888 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Lower,Day 12,n=20,18 | 1.206 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Central,Day 28,n=16,19 | 0.871 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Distal,Day 12,n=20,18 | 1.278 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Distal,Day 12,n=18,17 | 1.098 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Lower,Day 28,n=18,20 | 1.315 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Distal,Day 28,n=16,19 | 0.857 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Total,Day 12,n=20,18 | 1.109 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Total,Day 12,n=18,17 | 0.972 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Central,Day 12,n=20,18 | 1.005 kPa*s/L |
| All NEMI | Change From Baseline in iRaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Total,Day 28,n=16,19 | 0.913 kPa*s/L |
Secondary
Change From Baseline in iVaw at FRC and TLC for Individual Regions
iVaw was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Screening, Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For Untrimmed data and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (n=X1, X2 in the category title). This table presents the untrimmed data (in rows with categories containing untrimmed), SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only.
Time frame: Baseline (Screening) and Days 12 and 28
Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Upper,Day 12,n=20,18 | 0.959 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Upper,Day 28,n=16,19 | 0.999 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Lower,Day 12,n=17,17 | 1.009 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Lower,Day 28,n=16,19 | 0.993 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Central,Day 12,n=18,17 | 1.025 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Central,Day 28,n=16,19 | 1.040 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Distal,Day 12,n=18,17 | 0.969 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Distal,Day 28,n=16,19 | 0.973 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Total,Day 12,n=18,17 | 1.021 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Total,Day 28,n=16,19 | 1.034 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Upper,Day 12,n=18,17 | 0.987 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Upper,Day 28,n=18,20 | 0.930 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Lower,Day 12,n=20,18 | 1.017 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Lower,Day 28,n=18,20 | 0.958 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Central,Day 12,n=20,18 | 1.019 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Central,Day 28,n=18,20 | 1.006 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Distal,Day 12,n=20,18 | 0.986 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Distal,Day 28,n=18,20 | 0.941 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Total,Day 12,n=20,18 | 1.011 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Total,Day 28,n=18,20 | 0.994 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Upper,Day 12,n= 18,17 | 0.959 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Upper, Day 28,n=16,19 | 1.014 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Lower, Day 12,n=17,17 | 1.060 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Untrimmed, Lower, Day 28,n=16,19 | 0.993 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Central, Day 12,n=18,17 | 1.033 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Central, Day 28,n=16,19 | 1.046 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Distal, Day 12,n=18,17 | 0.924 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Distal, Day 28,n=16,19 | 0.974 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Total, Day 12,n=18,17 | 1.023 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Total, Day 28,n=16,19 | 1.037 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Upper, Day 28,n=18,20 | 0.897 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Upper,Day 12,n= 20,18 | 0.957 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Lower, Day 12,n=20,18 | 1.057 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Untrimmed, Lower, Day 28,n=18,20 | 0.933 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Central, Day 12,n=20,18 | 1.020 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Central, Day 28,n=18,20 | 1.003 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Distal, Day 12,n=20,18 | 1.003 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Distal, Day 28,n=18,20 | 0.916 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Total, Day 12,n=20,18 | 1.008 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Total, Day 28,n=18,20 | 0.986 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Distal, Day 28,n=18,20 | 0.902 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Upper,Day 12,n=18,17 | 1.021 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Upper,Day 12,n= 18,17 | 1.047 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Upper,Day 28,n=16,19 | 1.039 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Central, Day 28,n=18,20 | 0.985 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Lower,Day 12,n=17,17 | 1.017 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Upper, Day 28,n=16,19 | 1.076 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Lower,Day 28,n=16,19 | 1.018 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Upper,Day 12,n= 20,18 | 0.950 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Central,Day 12,n=18,17 | 1.040 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Lower, Day 12,n=17,17 | 1.004 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Central,Day 28,n=16,19 | 1.040 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Upper, Day 28,n=18,20 | 0.912 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Distal,Day 12,n=18,17 | 1.017 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Untrimmed, Lower, Day 28,n=16,19 | 1.052 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Distal,Day 28,n=16,19 | 1.032 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Total, Day 28,n=18,20 | 0.965 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Total,Day 12,n=18,17 | 1.034 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Central, Day 12,n=18,17 | 1.047 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Total,Day 28,n=16,19 | 1.037 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Lower, Day 12,n=20,18 | 0.917 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Upper,Day 12,n=20,18 | 0.973 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Central, Day 28,n=16,19 | 1.043 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Upper,Day 28,n=18,20 | 0.935 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Distal, Day 12,n=20,18 | 0.932 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Lower,Day 12,n=20,18 | 0.960 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Distal, Day 12,n=18,17 | 1.025 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Lower,Day 28,n=18,20 | 0.902 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Untrimmed, Lower, Day 28,n=18,20 | 0.893 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Central,Day 12,n=20,18 | 1.013 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Distal, Day 28,n=16,19 | 1.066 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Central,Day 28,n=18,20 | 0.989 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Total, Day 12,n=20,18 | 0.994 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Distal,Day 12,n=20,18 | 0.966 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Total, Day 12,n=18,17 | 1.038 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Distal,Day 28,n=18,20 | 0.918 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Central, Day 12,n=20,18 | 1.012 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Total,Day 12,n=20,18 | 1.005 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Total, Day 28,n=16,19 | 1.041 Milliliters |
| All NEMI | Change From Baseline in iVaw at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Total,Day 28,n=18,20 | 0.973 Milliliters |
Secondary
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes
Change from Baseline in lung lobar volumes was measured at FRC and TLC scan conditions. Data was collected at longitudinal time points: Baseline (Screening), Day 12 and Day 28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe). The value at Screening was considered as Baseline. Change from baseline is the post-Baseline value minus the Baseline value. The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI.There was no intent to compare two devices.
Time frame: Baseline (Screening) and Days 12 and 28
Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | FRC,Right Upper,Day 12,n=17,16 | 0.989 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | FRC,Right Upper,Day 28,n=16,18 | 0.989 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | FRC,Left Upper,Day 12,n=18,17 | 0.995 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | FRC,Left Upper,Day 28,n=16,19 | 0.990 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | FRC,Right Middle,Day 12,n=17,16 | 0.931 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | FRC,Right Middle,Day 28,n=16,18 | 0.887 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | FRC,Right Lower,Day 12,n=18,17 | 1.021 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | FRC,Right Lower,Day 28,n=16,19 | 1.009 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | FRC,Left Lower,Day 12,n=18,17 | 0.996 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | FRC,Left Lower,Day 28,n=16,19 | 0.998 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | TLC,Right Upper,Day 12,n=19,17 | 0.991 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | TLC,Right Upper,Day 28,n=18,19 | 0.989 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | TLC,Left Upper,Day 12,n=20,18 | 1.003 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | TLC,Left Upper,Day 28,n=18,20 | 0.992 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | TLC,Right Middle,Day 12,n=19,17 | 0.935 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | TLC,Right Middle,Day 28,n=18,19 | 0.900 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | TLC,Right Lower,Day 12,n=20,18 | 1.027 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | TLC,Right Lower,Day 28,n=18,20 | 1.016 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | TLC,Left Lower,Day 12,n=20,18 | 1.015 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | TLC,Left Lower,Day 28,n=18,20 | 0.985 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | TLC,Right Lower,Day 28,n=18,20 | 0.975 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | FRC,Right Upper,Day 12,n=17,16 | 0.971 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | TLC,Right Upper,Day 12,n=19,17 | 0.992 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | FRC,Right Upper,Day 28,n=16,18 | 0.999 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | TLC,Right Middle,Day 28,n=18,19 | 0.998 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | FRC,Left Upper,Day 12,n=18,17 | 0.993 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | TLC,Right Upper,Day 28,n=18,19 | 0.984 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | FRC,Left Upper,Day 28,n=16,19 | 1.008 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | TLC,Left Lower,Day 28,n=18,20 | 0.971 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | FRC,Right Middle,Day 12,n=17,16 | 0.979 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | TLC,Left Upper,Day 12,n=20,18 | 0.990 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | FRC,Right Middle,Day 28,n=16,18 | 1.010 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | TLC,Right Lower,Day 12,n=20,18 | 0.973 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | FRC,Right Lower,Day 12,n=18,17 | 0.976 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | TLC,Left Upper,Day 28,n=18,20 | 0.987 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | FRC,Right Lower,Day 28,n=16,19 | 0.984 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | TLC,Left Lower,Day 12,n=20,18 | 0.977 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | FRC,Left Lower,Day 12,n=18,17 | 0.979 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | TLC,Right Middle,Day 12,n=19,17 | 0.990 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes | FRC,Left Lower,Day 28,n=16,19 | 0.969 Liters |
Secondary
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions
Change from Baseline in lung lobar volumes was measured at FRC and TLC scan conditions. Data was collected at longitudinal time points: Baseline (Screening), Day 12 and Day 28. At each time point it was measure at 5 Regions (Upper, Lower, Central, Distal & Total). The value at Screening was considered as Baseline. Change from Baseline is the post-Baseline value minus the Baseline value. The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI.There was no intent to compare two devices.
Time frame: Baseline (Screening) and Days 12 and 28
Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions | FRC,Upper,Day 28,n=16,19 | 0.987 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions | TLC,Upper,Day 12,n=20,18 | 0.997 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions | FRC,Lower,Day 28,n=16,19 | 1.002 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions | TLC,Upper,Day 28,n=18,20 | 0.990 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions | FRC,Upper,Day 12,n=18,17 | 0.991 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions | TLC,Lower,Day 12,n=20,18 | 1.021 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions | FRC,Total,Day 12,n=18,17 | 0.998 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions | TLC,Lower,Day 28,n=18,20 | 1.000 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions | FRC,Lower,Day 12,n=18,17 | 1.008 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions | TLC,Total,Day 12,n=20,18 | 1.008 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions | FRC,Total,Day 28,n=16,19 | 0.993 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions | TLC,Total,Day 28,n=18,20 | 0.993 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions | FRC,Total,Day 28,n=16,19 | 0.995 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions | FRC,Upper,Day 12,n=18,17 | 0.997 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions | FRC,Upper,Day 28,n=16,19 | 1.010 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions | FRC,Lower,Day 12,n=18,17 | 0.979 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions | FRC,Lower,Day 28,n=16,19 | 0.978 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions | FRC,Total,Day 12,n=18,17 | 0.988 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions | TLC,Total,Day 28,n=18,20 | 0.983 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions | TLC,Upper,Day 12,n=20,18 | 0.991 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions | TLC,Upper,Day 28,n=18,20 | 0.989 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions | TLC,Lower,Day 12,n=20,18 | 0.977 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions | TLC,Lower,Day 28,n=18,20 | 0.975 Liters |
| All NEMI | Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions | TLC,Total,Day 12,n=20,18 | 0.985 Liters |
Secondary
Change From Baseline in siVaw at FRC and TLC for Individual Regions
siVaw was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Baseline (Screening), Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For Untrimmed data and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (n=X1, X2 in the category title).This table presents the untrimmed data (in rows with categories containing untrimmed), SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only.
Time frame: Baseline (Screening), Days 12 and 28
Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Distal,Day 28,n=16,19 | 0.980 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Central, Day 28,n=16,19 | 1.054 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC, Scan Trimmed,Central,Day 28,n=18,20 | 1.013 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Distal, Day 12,n=18,17 | 0.926 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC, Scan Trimmed,Upper,Day 12,n=20,18 | 0.963 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Distal, Day 28,n=16,19 | 0.981 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC, Scan Trimmed,Distal,Day 12,n=20,18 | 0.979 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Total, Day 12,n=18,17 | 1.025 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Total,Day 28,n=16,19 | 1.041 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Total, Day 28,n=16,19 | 1.045 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC, Scan Trimmed,Distal,Day 28,n=18,20 | 0.948 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Upper,Day 12,n= 20,18 | 0.961 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC, Scan Trimmed,Upper,Day 28,n=18,20 | 0.939 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Upper, Day 28,n=18,20 | 0.906 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC, Scan Trimmed,Total,Day 12,n=20,18 | 1.004 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Lower, Day 12,n=20,18 | 1.035 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Distal,Day 12,n=18,17 | 0.970 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC,Untrimmed, Lower, Day 28,n=18,20 | 0.933 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC, Scan Trimmed,Total,Day 28,n=18,20 | 1.001 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Central, Day 12,n=20,18 | 1.012 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC, Scan Trimmed,Lower,Day 12,n=20,18 | 0.996 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Central, Day 28,n=18,20 | 1.010 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Upper,Day 12,n= 18,17 | 0.967 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Distal, Day 12,n=20,18 | 0.996 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Total,Day 12,n=18,17 | 1.023 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Distal, Day 28,n=18,20 | 0.922 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Upper, Day 28,n=16,19 | 1.027 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Total, Day 12,n=20,18 | 1.000 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC, Scan Trimmed,Lower,Day 28,n=18,20 | 0.958 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Total, Day 28,n=18,20 | 0.993 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Lower, Day 12,n=17,17 | 1.055 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Upper,Day 12,n=18,17 | 0.996 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Central,Day 28,n=16,19 | 1.048 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Upper,Day 28,n=16,19 | 1.011 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Untrimmed, Lower, Day 28,n=16,19 | 0.991 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Lower,Day 12,n=17,17 | 1.003 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC, Scan Trimmed,Central,Day 12,n=20,18 | 1.011 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Lower,Day 28,n=16,19 | 0.991 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Central, Day 12,n=18,17 | 1.035 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Central,Day 12,n=18,17 | 1.027 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Total, Day 28,n=16,19 | 1.046 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Central,Day 28,n=16,19 | 1.045 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Distal,Day 12,n=18,17 | 1.029 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Distal,Day 28,n=16,19 | 1.037 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Total,Day 12,n=18,17 | 1.046 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Total,Day 28,n=16,19 | 1.042 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC, Scan Trimmed,Upper,Day 12,n=20,18 | 0.982 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC, Scan Trimmed,Upper,Day 28,n=18,20 | 0.945 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC, Scan Trimmed,Lower,Day 12,n=20,18 | 0.982 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC, Scan Trimmed,Lower,Day 28,n=18,20 | 0.925 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC, Scan Trimmed,Central,Day 12,n=20,18 | 1.029 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC, Scan Trimmed,Central,Day 28,n=18,20 | 1.006 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC, Scan Trimmed,Distal,Day 12,n=20,18 | 0.981 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC, Scan Trimmed,Distal,Day 28,n=18,20 | 0.934 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC, Scan Trimmed,Total,Day 12,n=20,18 | 1.020 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC, Scan Trimmed,Total,Day 28,n=18,20 | 0.990 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Upper,Day 12,n= 18,17 | 1.050 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Upper, Day 28,n=16,19 | 1.066 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Lower, Day 12,n=17,17 | 1.026 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Untrimmed, Lower, Day 28,n=16,19 | 1.077 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Central, Day 12,n=18,17 | 1.059 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Central, Day 28,n=16,19 | 1.048 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Distal, Day 12,n=18,17 | 1.037 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Distal, Day 28,n=16,19 | 1.071 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Untrimmed,Total, Day 12,n=18,17 | 1.050 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Central,Day 12,n=18,17 | 1.052 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Upper,Day 12,n= 20,18 | 0.959 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Upper, Day 28,n=18,20 | 0.923 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Lower, Day 12,n=20,18 | 0.938 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC,Untrimmed, Lower, Day 28,n=18,20 | 0.916 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Central, Day 12,n=20,18 | 1.027 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Central, Day 28,n=18,20 | 1.002 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Distal, Day 12,n=20,18 | 0.946 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Distal, Day 28,n=18,20 | 0.918 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Total, Day 12,n=20,18 | 1.009 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | TLC,Untrimmed,Total, Day 28,n=18,20 | 0.982 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Upper,Day 12,n=18,17 | 1.024 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Upper,Day 28,n=16,19 | 1.029 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Lower,Day 12,n=17,17 | 1.039 Milliliters per Liter |
| All NEMI | Change From Baseline in siVaw at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Lower,Day 28,n=16,19 | 1.041 Milliliters per Liter |
Secondary
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes
siRaw is a measure of the resistance in an individual's airway corrected for their lobar volume derived from the HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analysed (represented by n=X1, X2 in the category title). This table presents the SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only.
Time frame: Baseline (Screening) and Days 12 and 28
Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Right Upper,Day 12,n=17,16 | 1.117 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Right Upper,Day 28,n=16,18 | 1.200 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Left Upper,Day 12,n=18,17 | 1.053 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Left Upper,Day 28,n=16,19 | 1.139 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Right Middle,Day 12,n=17,16 | 0.496 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Right Middle,Day 28,n=16,18 | 1.259 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Right Lower,Day 12,n=17,17 | 0.921 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Right Lower,Day 28,n=16,19 | 0.688 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Left Lower,Day 12,n=17,17 | 1.075 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Left Lower,Day 28,n=16,19 | 1.573 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Upper,Day 12,n=19,17 | 1.037 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Upper,Day 28,n=18,19 | 1.292 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Left Upper,Day 12,n=20,18 | 1.133 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Left Upper,Day 28,n=18,20 | 1.203 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Middle,Day 12,n=18,17 | 1.094 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Middle,Day 28,n=18,19 | 1.575 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Lower,Day 12,n=20,18 | 0.747 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Lower,Day 28,n=18,20 | 1.161 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Left Lower,Day 12,n=20,18 | 1.018 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Left Lower,Day 28,n=18,20 | 1.240 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Lower,Day 28,n=18,20 | 1.427 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Right Upper,Day 12,n=17,16 | 0.961 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Upper,Day 12,n=19,17 | 1.035 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Right Upper,Day 28,n=16,18 | 0.923 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Middle,Day 28,n=18,19 | 1.557 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Left Upper,Day 12,n=18,17 | 0.945 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Upper,Day 28,n=18,19 | 1.262 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Left Upper,Day 28,n=16,19 | 0.687 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Left Lower,Day 28,n=18,20 | 1.178 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Right Middle,Day 12,n=17,16 | 1.022 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Left Upper,Day 12,n=20,18 | 1.064 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Right Middle,Day 28,n=16,18 | 1.424 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Lower,Day 12,n=20,18 | 1.290 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Right Lower,Day 12,n=17,17 | 1.121 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Left Upper,Day 28,n=18,20 | 1.145 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Right Lower,Day 28,n=16,19 | 0.920 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Left Lower,Day 12,n=20,18 | 1.118 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Left Lower,Day 12,n=17,17 | 0.884 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | TLC,Scan Trimmed,Right Middle,Day 12,n=18,17 | 1.101 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes | FRC,Scan Trimmed,Left Lower,Day 28,n=16,19 | 0.876 kPa*s |
Secondary
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions
siRaw is a measure of the resistance in an individual's airway corrected for their lobar volume derived from the HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analysed (represented by n=X1, X2 in the category title). This table presents the SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only.
Time frame: Baseline (Screening) and Days 12 and 28
Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Upper,Day 28,n=16,19 | 1.377 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Upper,Day 12,n=18,17 | 0.820 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Lower,Day 12,n=17,17 | 1.118 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Lower,Day 28,n=16,19 | 1.073 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Central,Day 12,n=18,17 | 0.931 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Central,Day 28,n=16,19 | 0.870 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Distal,Day 12,n=18,17 | 0.999 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Distal,Day 28,n=16,19 | 1.161 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Total,Day 12,n=18,17 | 0.983 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Total,Day 28,n=16,19 | 1.038 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Upper,Day 12,n=20,18 | 1.139 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Upper,Day 28,n=18,20 | 1.524 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Lower,Day 12,n=20,18 | 0.878 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Lower,Day 28,n=18,20 | 1.142 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Central,Day 12,n=20,18 | 0.994 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Central,Day 28,n=18,20 | 0.978 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Distal,Day 12,n=20,18 | 0.966 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Distal,Day 28,n=18,20 | 1.323 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Total,Day 12,n=20,18 | 1.000 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Total,Day 28,n=18,20 | 1.188 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Distal,Day 28,n=18,20 | 1.266 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Upper,Day 12,n=20,18 | 1.156 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Upper,Day 12,n=18,17 | 0.828 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Upper,Day 28,n=16,19 | 0.784 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Central,Day 28,n=18,20 | 1.039 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Lower,Day 12,n=17,17 | 1.043 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Upper,Day 28,n=18,20 | 1.257 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Lower,Day 28,n=16,19 | 0.891 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Total,Day 28,n=18,20 | 1.181 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Central,Day 12,n=18,17 | 0.878 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Lower,Day 12,n=20,18 | 1.179 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Central,Day 28,n=16,19 | 0.867 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Distal,Day 12,n=20,18 | 1.259 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Distal,Day 12,n=18,17 | 1.085 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Lower,Day 28,n=18,20 | 1.282 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Distal,Day 28,n=16,19 | 0.853 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Total,Day 12,n=20,18 | 1.093 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Total,Day 12,n=18,17 | 0.961 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | TLC,Scan Trimmed,Central,Day 12,n=20,18 | 0.990 kPa*s |
| All NEMI | Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions | FRC,Scan Trimmed,Total,Day 28,n=16,19 | 0.909 kPa*s |
Secondary
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
siVaw was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Baseline (Screening), Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For Untrimmed data and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (n=X1, X2 in the category title). This table presents the untrimmed data (in rows with categories containing untrimmed), SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only.
Time frame: Baseline (Screening), Days 12 and 28
Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Scan Trimmed,Right Middle,Day 28,n=16,18 | 1.071 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Scan Trimmed,Left Upper,Day 12,n=20,18 | 0.954 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Scan Trimmed,Left Upper,Day 28,n=18,20 | 0.935 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Scan Trimmed,Right Middle,Day 12,n=18,17 | 0.958 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Scan Trimmed,Right Middle,Day 28,n=18,19 | 0.969 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Scan Trimmed,Right Lower,Day 12,n=20,18 | 1.054 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Scan Trimmed,Right Upper,Day 12,n=17,16 | 1.020 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Scan Trimmed,Right Upper,Day 28,n=16,18 | 1.027 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Scan Trimmed,Left Upper,Day 12,n=18,17 | 0.970 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Scan Trimmed,Left Upper,Day 28,n=16,19 | 1.008 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Scan Trimmed,Right Middle,Day 12,n=17,16 | 1.294 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Scan Trimmed,Right Lower,Day 12,n=17,17 | 1.025 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Scan Trimmed,Right Lower,Day 28,n=16,19 | 1.032 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Scan Trimmed,Left Lower,Day 12,n=17,17 | 1.012 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Scan Trimmed,Left Lower,Day 28,n=16,19 | 0.973 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Scan Trimmed,Right Upper,Day 12,n=19,17 | 0.991 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Scan Trimmed,Right Upper,Day 28,n=18,19 | 0.951 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Scan Trimmed,Right Lower,Day 28,n=18,20 | 0.952 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Scan Trimmed,Left Lower,Day 12,n=20,18 | 0.967 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Scan Trimmed,Left Lower,Day 28,n=18,20 | 0.953 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Untrimmed,Right Upper,Day 12,n= 17,16 | 0.900 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Untrimmed,Right Upper, Day 28,n=16,18 | 1.001 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Untrimmed,Left Upper, Day 12,n=18,17 | 1.001 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | Untrimmed,Left Upper, Day 28,n=16,19 | 1.082 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Untrimmed,Right Middle, Day 12,n=17,16 | 1.347 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Untrimmed,Right Middle, Day 28,n=16,18 | 1.118 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Untrimmed,Right Lower, Day 12,n=17,17 | 1.237 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Untrimmed,Right Lower, Day 28,n=16,19 | 1.241 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Untrimmed,Left Lower, Day 12,n=17,17 | 0.967 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Untrimmed,Left Lower, Day 28,n=16,19 | 0.815 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Untrimmed,Right Upper,Day 12,n=19,17 | 0.982 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Untrimmed,Right Upper, Day 28,n=18,19 | 0.884 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Untrimmed,Left Upper, Day 12,n=20,18 | 0.955 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Untrimmed,Left Upper, Day 28,n=18,20 | 0.949 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Untrimmed,Right Middle, Day 12,n=18,17 | 0.942 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Untrimmed,Right Middle, Day 28,n=18,19 | 0.691 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Untrimmed,Right Lower, Day 12,n=20,18 | 1.131 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Untrimmed,Right Lower, Day 28,n=18,20 | 0.948 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Untrimmed,Left Lower, Day 12,n=20,18 | 0.982 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Untrimmed,Left Lower, Day 28,n=18,20 | 0.894 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Untrimmed,Right Lower, Day 28,n=18,20 | 0.865 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Untrimmed,Right Upper,Day 12,n= 17,16 | 1.071 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Scan Trimmed,Left Upper,Day 12,n=20,18 | 0.968 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Untrimmed,Right Upper,Day 12,n=19,17 | 1.002 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Scan Trimmed,Left Upper,Day 28,n=18,20 | 0.950 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Untrimmed,Right Upper, Day 28,n=16,18 | 1.073 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Scan Trimmed,Right Middle,Day 12,n=18,17 | 1.008 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Untrimmed,Right Middle, Day 28,n=18,19 | 0.892 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Scan Trimmed,Right Middle,Day 28,n=18,19 | 0.900 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Untrimmed,Left Upper, Day 12,n=18,17 | 0.956 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Untrimmed,Right Upper, Day 28,n=18,19 | 0.941 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Scan Trimmed,Right Upper,Day 12,n=17,16 | 1.038 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | Untrimmed,Left Upper, Day 28,n=16,19 | 1.065 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Scan Trimmed,Right Upper,Day 28,n=16,18 | 1.030 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Untrimmed,Left Lower, Day 28,n=18,20 | 0.967 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Scan Trimmed,Left Upper,Day 12,n=18,17 | 0.993 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Untrimmed,Right Middle, Day 12,n=17,16 | 1.058 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Scan Trimmed,Left Upper,Day 28,n=16,19 | 1.053 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Untrimmed,Left Upper, Day 12,n=20,18 | 0.942 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Scan Trimmed,Right Middle,Day 12,n=17,16 | 1.008 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Scan Trimmed,Right Upper,Day 28,n=18,19 | 0.964 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Scan Trimmed,Right Middle,Day 28,n=16,18 | 0.973 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Untrimmed,Right Middle, Day 28,n=16,18 | 1.007 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Scan Trimmed,Right Lower,Day 12,n=17,17 | 1.029 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Untrimmed,Right Lower, Day 12,n=20,18 | 0.895 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Scan Trimmed,Right Lower,Day 28,n=16,19 | 1.042 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Untrimmed,Right Lower, Day 12,n=17,17 | 1.014 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Scan Trimmed,Left Lower,Day 12,n=17,17 | 1.032 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Untrimmed,Left Upper, Day 28,n=18,20 | 0.926 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Scan Trimmed,Left Lower,Day 28,n=16,19 | 1.062 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Untrimmed,Right Lower, Day 28,n=16,19 | 1.031 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Scan Trimmed,Right Upper,Day 12,n=19,17 | 0.999 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Untrimmed,Left Lower, Day 12,n=20,18 | 0.989 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Scan Trimmed,Right Lower,Day 12,n=20,18 | 0.963 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Untrimmed,Left Lower, Day 12,n=17,17 | 1.002 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Scan Trimmed,Right Lower,Day 28,n=18,20 | 0.899 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Untrimmed,Right Middle, Day 12,n=18,17 | 0.970 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Scan Trimmed,Left Lower,Day 12,n=20,18 | 1.004 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | FRC,Untrimmed,Left Lower, Day 28,n=16,19 | 1.142 Milliliters per Liter |
| All NEMI | Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes | TLC,Scan Trimmed,Left Lower,Day 28,n=18,20 | 0.950 Milliliters per Liter |
Secondary
Change From Baseline in Trachea Length and Diameter at FRC and TLC
Trachea length and diameter was derived from HRCT. It was measured at both FRC and TLC scan conditions. The value at Screening was considered as Baseline. Change from Baseline is the post-Baseline value minus the Baseline value. The change from Baseline data is presented for Day 12 and Day 28 for trachea length and diameter. The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI.There was no intent to compare two devices.
Time frame: Baseline (Screening) and Days 12 and 28
Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All NEMI | Change From Baseline in Trachea Length and Diameter at FRC and TLC | FRC,Length,Day 12,n=18,17 | 0.094 Millimeters | Standard Deviation 7.2507 |
| All NEMI | Change From Baseline in Trachea Length and Diameter at FRC and TLC | FRC,Length,Day 28,n=16,19 | 0.796 Millimeters | Standard Deviation 7.7795 |
| All NEMI | Change From Baseline in Trachea Length and Diameter at FRC and TLC | FRC,Diameter,Day 12,n=18,17 | 0.225 Millimeters | Standard Deviation 1.3641 |
| All NEMI | Change From Baseline in Trachea Length and Diameter at FRC and TLC | FRC,Diameter,Day 28,n=16,19 | 0.225 Millimeters | Standard Deviation 1.3812 |
| All NEMI | Change From Baseline in Trachea Length and Diameter at FRC and TLC | TLC,Length,Day 12,n=20,18 | -0.164 Millimeters | Standard Deviation 2.8331 |
| All NEMI | Change From Baseline in Trachea Length and Diameter at FRC and TLC | TLC,Length,Day 28,n=18,20 | -0.094 Millimeters | Standard Deviation 2.848 |
| All NEMI | Change From Baseline in Trachea Length and Diameter at FRC and TLC | TLC,Diameter,Day 12,n=20,18 | 0.134 Millimeters | Standard Deviation 0.467 |
| All NEMI | Change From Baseline in Trachea Length and Diameter at FRC and TLC | TLC,Diameter,Day 28,n=18,20 | 0.076 Millimeters | Standard Deviation 0.4751 |
| All NEMI | Change From Baseline in Trachea Length and Diameter at FRC and TLC | TLC,Diameter,Day 28,n=18,20 | -0.188 Millimeters | Standard Deviation 0.4983 |
| All NEMI | Change From Baseline in Trachea Length and Diameter at FRC and TLC | FRC,Length,Day 12,n=18,17 | 0.972 Millimeters | Standard Deviation 6.5552 |
| All NEMI | Change From Baseline in Trachea Length and Diameter at FRC and TLC | TLC,Length,Day 12,n=20,18 | 0.827 Millimeters | Standard Deviation 3.1842 |
| All NEMI | Change From Baseline in Trachea Length and Diameter at FRC and TLC | FRC,Length,Day 28,n=16,19 | 0.281 Millimeters | Standard Deviation 5.1808 |
| All NEMI | Change From Baseline in Trachea Length and Diameter at FRC and TLC | TLC,Diameter,Day 12,n=20,18 | 0.070 Millimeters | Standard Deviation 0.4222 |
| All NEMI | Change From Baseline in Trachea Length and Diameter at FRC and TLC | FRC,Diameter,Day 12,n=18,17 | 0.252 Millimeters | Standard Deviation 1.0023 |
| All NEMI | Change From Baseline in Trachea Length and Diameter at FRC and TLC | TLC,Length,Day 28,n=18,20 | 0.069 Millimeters | Standard Deviation 3.4882 |
| All NEMI | Change From Baseline in Trachea Length and Diameter at FRC and TLC | FRC,Diameter,Day 28,n=16,19 | 0.116 Millimeters | Standard Deviation 1.16 |
Secondary
Maximum Plasma Concentration (Cmax) Following Administration of NEMI
Blood samples for pharmacokinetic (PK) analysis was collected at the indicated time points following administration of NEMI via DISKUS and ELLIPTA.
Time frame: Day 1: 5 minutes Post-dose on Day 1
Population: Pharmacokinetic Population comprised of participants in all subject population for whom a pharmacokinetic sample was obtained and analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| All NEMI | Maximum Plasma Concentration (Cmax) Following Administration of NEMI | 508.4 Picograms per milliliter | Geometric Coefficient of Variation 69 |
| All NEMI | Maximum Plasma Concentration (Cmax) Following Administration of NEMI | 1103.4 Picograms per milliliter | Geometric Coefficient of Variation 34 |
Secondary
Mean Number of Occasions of Rescue Usage Per Day
For reliever/rescue use, bronchodilator use recorded in the diary was summarized as the mean number of occasions of rescue use per day.where a rescue-free day was defined as a 24-hour period in which the number of occasions of bronchodilator use was zero. Number of occasions bronchodilator taken in the last 24 hours were collected in the daily diary. The mean number of occasions of rescue use per day, were calculated for each participant during the four weekly periods (Weeks 1 to 4; Weeks 5-8 and Weeks 9-12). The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI.There was no intent to compare two devices.
Time frame: Weeks 1 to 4; Weeks 5 to 8 and Weeks 9 to 12
Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All NEMI | Mean Number of Occasions of Rescue Usage Per Day | Weeks 1-4,n=22,21 | 3.05 Rescue use per day | Standard Deviation 2.52 |
| All NEMI | Mean Number of Occasions of Rescue Usage Per Day | Weeks 5-8,n=19,20 | 2.93 Rescue use per day | Standard Deviation 2.342 |
| All NEMI | Mean Number of Occasions of Rescue Usage Per Day | Weeks 9-12,n=19,20 | 3.19 Rescue use per day | Standard Deviation 2.065 |
| All NEMI | Mean Number of Occasions of Rescue Usage Per Day | Weeks 1-4,n=22,21 | 2.77 Rescue use per day | Standard Deviation 2.432 |
| All NEMI | Mean Number of Occasions of Rescue Usage Per Day | Weeks 5-8,n=19,20 | 2.81 Rescue use per day | Standard Deviation 2.827 |
| All NEMI | Mean Number of Occasions of Rescue Usage Per Day | Weeks 9-12,n=19,20 | 2.84 Rescue use per day | Standard Deviation 2.569 |
Secondary
Mean Rescue Medication Free Days
For reliever/rescue use, bronchodilator use recorded in the diary was summarized as the mean number of occasions of rescue use per day, where a rescue-free day was defined as a 24-hour period in which the number of occasions of bronchodilator use was zero. Number of occasions bronchodilator taken in the last 24 hours were collected in the daily diary. The mean number of rescue free days were calculated for each participant during the four weekly periods (Weeks 1 to 4; Weeks 5-8 and Weeks 9-12). The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI. There was no intent to compare two devices.
Time frame: Weeks 1 to 4; Weeks 5 to 8 and Weeks 9 to 12
Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All NEMI | Mean Rescue Medication Free Days | Weeks 1-4,n=22,21 | 7.5 Days | Standard Deviation 9.21 |
| All NEMI | Mean Rescue Medication Free Days | Weeks 5-8,n=19,20 | 5.8 Days | Standard Deviation 8.58 |
| All NEMI | Mean Rescue Medication Free Days | Weeks 9-12,n=19,20 | 3.7 Days | Standard Deviation 6.68 |
| All NEMI | Mean Rescue Medication Free Days | Weeks 1-4,n=22,21 | 7.7 Days | Standard Deviation 10.06 |
| All NEMI | Mean Rescue Medication Free Days | Weeks 5-8,n=19,20 | 9.0 Days | Standard Deviation 12.14 |
| All NEMI | Mean Rescue Medication Free Days | Weeks 9-12,n=19,20 | 7.9 Days | Standard Deviation 11.14 |
Secondary
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
An AE is any untoward medical occurrence in a clinical investigation participant, or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward medical occurrence that at any dose, resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, is associated with liver injury and impaired liver function or any other situation according to medical or scientific judgment was categorized as SAE. Number of participants with AEs and SAEs have been reported.
Time frame: Up to 14 weeks
Population: All Subjects Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All NEMI | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any AE | 11 Participants |
| All NEMI | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any SAE | 2 Participants |
| All NEMI | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any AE | 11 Participants |
| All NEMI | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any SAE | 3 Participants |
| Placebo Via ELLIPTA | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any AE | 5 Participants |
| Placebo Via ELLIPTA | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any SAE | 4 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any SAE | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any AE | 5 Participants |
Secondary
Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline
Blood samples were collected to analyze the following Chemistry parameters: Albumin, Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Direct Bilirubin, Total Bilirubin, Calcium, C-Reactive protein, Creatinine, Glucose, Potassium, Sodium, Total Protein and Urea/Blood urea nitrogen. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose lab value category was unchanged e.g. High to High), or whose value became normal, were not recorded. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. The value at Screening was considered as Baseline. Data for Worst Case Laboratory chemistry values Post-Baseline Relative to Baseline has been presented.
Time frame: Baseline (Screening) and up to 14 weeks
Population: All Subjects Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | ALT,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Glucose,To Low | 1 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Direct Bilirubin,To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Potassium,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Total Bilirubin,To High | 1 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | ALT,To High | 1 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Potassium,To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Creatinine,To Low | 1 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Sodium,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | ALP,To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | C-Reactive protein,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | C-Reactive protein,To High | 4 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Sodium,To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Calcium,To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Calcium,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Total Protein,To Low | 1 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | AST,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Total Bilirubin,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Total Protein,To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | ALP,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Urea/BUN,To Low | 1 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | AST,To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Urea/BUN,To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Albumin,To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Direct Bilirubin,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Albumin,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Glucose,To High | 3 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Creatinine,To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Direct Bilirubin,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Albumin,To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | ALP,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Glucose,To Low | 1 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | ALP,To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Total Bilirubin,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Creatinine,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | ALT,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | ALT,To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | C-Reactive protein,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | AST,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Total Protein,To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | AST,To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Glucose,To High | 2 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Potassium,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Total Bilirubin,To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Direct Bilirubin,To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Calcium,To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Potassium,To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Sodium,To Low | 2 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Sodium,To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Total Protein,To Low | 1 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | C-Reactive protein,To High | 5 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Calcium,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Urea/BUN,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Urea/BUN,To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Albumin,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Creatinine,To High | 1 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Urea/BUN,To High | 1 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Direct Bilirubin,To Low | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Direct Bilirubin,To High | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Creatinine,To High | 1 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Total Bilirubin,To Low | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Total Bilirubin,To High | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Calcium,To Low | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Glucose,To High | 2 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Potassium,To High | 1 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Glucose,To Low | 1 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Total Protein,To Low | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Urea/BUN,To Low | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | C-Reactive protein,To Low | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Potassium,To Low | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Sodium,To Low | 2 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Sodium,To High | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Total Protein,To High | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Albumin,To Low | 1 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | C-Reactive protein,To High | 3 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Albumin,To High | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Calcium,To High | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | ALP,To Low | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | ALP,To High | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | ALT,To Low | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Creatinine,To Low | 1 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | ALT,To High | 1 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | AST,To Low | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | AST,To High | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Urea/BUN,To High | 1 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Total Bilirubin,To Low | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Calcium,To Low | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Calcium,To High | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | C-Reactive protein,To Low | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | C-Reactive protein,To High | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Creatinine,To Low | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Creatinine,To High | 1 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Glucose,To Low | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Glucose,To High | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Potassium,To Low | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Sodium,To Low | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Total Protein,To Low | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Albumin,To Low | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Albumin,To High | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | ALP,To Low | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | ALP,To High | 1 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | ALT,To Low | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | ALT,To High | 1 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | AST,To High | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Direct Bilirubin,To Low | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Direct Bilirubin,To High | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Total Bilirubin,To High | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Total Protein,To High | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Potassium,To High | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Sodium,To High | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | Urea/BUN,To Low | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline | AST,To Low | 0 Participants |
Secondary
Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline
Blood samples were collected to analyze the following s hematology parameters: Hemoglobin, Hematocrit, Mean Corpuscle Hemoglobin (MCH), Mean Corpuscle Volume (MCV), Platelet count, Red Blood Cell (RBC) count, White Blood Cell (WBC) count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils. Participants were counted in the worst case category that their value changes to (low or high), unless there is no change in their category. Participants whose lab value category was unchanged (example given \[e.g.\],High to High), or whose value became normal, were not recorded. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. The value at Screening was considered as Baseline. Data for Worst Case Laboratory Hematology values Post-Baseline Relative to Baseline has been presented.
Time frame: Baseline (Screening) and up to 14 weeks
Population: All Subjects Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Eosinophils,To High | 1 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Basophils,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Basophils,To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Eosinophils,To Low | 2 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Hemoglobin,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Hemoglobin,To High | 1 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Hematocrit,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Hematocrit,To High | 3 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Lymphocytes,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Lymphocytes,To High | 1 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | MCH,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | MCH,To High | 1 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | MCV,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | MCV,To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Monocytes,To Low | 2 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Monocytes,To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Total Neutrophils,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Total Neutrophils,To High | 4 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Platelet count,To Low | 1 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Platelet count,To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | RBC,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | RBC,To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | WBC,To Low | 1 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | WBC,To High | 4 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | WBC,To High | 2 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | MCV,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Eosinophils,To High | 1 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | WBC,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | RBC,To High | 1 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | MCV,To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Lymphocytes,To Low | 1 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Total Neutrophils,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Hemoglobin,To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Monocytes,To Low | 3 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Eosinophils,To Low | 4 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Monocytes,To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | RBC,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Lymphocytes,To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Platelet count,To High | 1 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Basophils,To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Hematocrit,To High | 3 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | MCH,To Low | 1 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Hematocrit,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Basophils,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Platelet count,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | MCH,To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Hemoglobin,To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Total Neutrophils,To High | 1 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | MCH,To Low | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Hematocrit,To Low | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Hematocrit,To High | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Lymphocytes,To Low | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Lymphocytes,To High | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | RBC,To Low | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Platelet count,To High | 1 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | MCH,To High | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | MCV,To Low | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | MCV,To High | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | RBC,To High | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Monocytes,To Low | 1 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Monocytes,To High | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | WBC,To High | 2 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Total Neutrophils,To Low | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Total Neutrophils,To High | 2 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | WBC,To Low | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Basophils,To Low | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Platelet count,To Low | 1 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Hemoglobin,To High | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Basophils,To High | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Eosinophils,To Low | 1 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Eosinophils,To High | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Hemoglobin,To Low | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Eosinophils,To High | 1 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | RBC,To Low | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | MCH,To Low | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | WBC,To Low | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Basophils,To Low | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Hematocrit,To High | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Hemoglobin,To High | 2 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Lymphocytes,To High | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Hemoglobin,To Low | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Basophils,To High | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Platelet count,To Low | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Lymphocytes,To Low | 1 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | RBC,To High | 1 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Monocytes,To Low | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Platelet count,To High | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Monocytes,To High | 1 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Eosinophils,To Low | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | MCV,To High | 1 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | WBC,To High | 1 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Total Neutrophils,To Low | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | MCV,To Low | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | MCH,To High | 1 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Hematocrit,To Low | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline | Total Neutrophils,To High | 1 Participants |
Secondary
Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings
A Single 12-lead ECGs was obtained at screening and at each other timepoint during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF) intervals. Data for number of participants with worst case post-Baseline abnormal ECG findings was reported. The value at Screening was considered as Baseline.
Time frame: Up to 14 weeks
Population: All Subjects Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All NEMI | Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Abnormal - clinically significant | 0 Participants |
| All NEMI | Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Abnormal - not clinically significant | 10 Participants |
| All NEMI | Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Abnormal - clinically significant | 0 Participants |
| All NEMI | Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Abnormal - not clinically significant | 7 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Abnormal - clinically significant | 1 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Abnormal - not clinically significant | 6 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Abnormal - not clinically significant | 7 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | Abnormal - clinically significant | 0 Participants |
Secondary
Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Vital signs were measured in semi-supine position after 5 minutes rest and included Systolic blood pressure (SBP), Diastolic blood pressure (DBP), Heart rate (HR). Data for number of participants with Post-Baseline worst case Vital Sign results relative to PCI Criteria relative to Baseline was presented. PCI ranges were: SBP (lower: \<85 and upper: \>160 mmHg), DBP (lower: \<45 and upper: \>100 mmHg), and HR (lower: \<40 and upper: \>110 bpm). The value at Screening was considered as Baseline.
Time frame: Baseline (Screening) and up to 14 weeks
Population: All Subjects Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All NEMI | Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | SBP, To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | HR, To High | 2 Participants |
| All NEMI | Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | SBP, To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | HR, To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | HR, To High | 1 Participants |
| All NEMI | Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | SBP, To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | HR, To Low | 0 Participants |
| All NEMI | Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, To High | 0 Participants |
| All NEMI | Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | SBP, To Low | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | HR, To Low | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | HR, To High | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, To High | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | SBP, To High | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, To Low | 0 Participants |
| Placebo Via ELLIPTA | Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | SBP, To Low | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, To High | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | HR, To Low | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | DBP, To Low | 0 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | HR, To High | 1 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | SBP, To High | 2 Participants |
| NEMI 700 mcg Via ELLIPTA | Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | SBP, To Low | 0 Participants |
Secondary
Trough Concentration Following Administration of NEMI
Blood samples for pharmacokinetic (PK) analysis was collected at the indicated time points following administration of NEMI via DISKUS and ELLIPTA.
Time frame: Day 1: 24 Hours post-dose; Days 12, 28, 56, 84: Pre-dose
Population: Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| All NEMI | Trough Concentration Following Administration of NEMI | Day 12,pre-dose,n=9,5 | 1097.1 Picograms per milliliter | Geometric Coefficient of Variation 38 |
| All NEMI | Trough Concentration Following Administration of NEMI | Day 56,pre-dose,n=11,7 | 1155.1 Picograms per milliliter | Geometric Coefficient of Variation 60 |
| All NEMI | Trough Concentration Following Administration of NEMI | Day 28,pre-dose, n=9,7 | 1194.3 Picograms per milliliter | Geometric Coefficient of Variation 76 |
| All NEMI | Trough Concentration Following Administration of NEMI | Day 84,pre-dose,n=11,7 | 1339.6 Picograms per milliliter | Geometric Coefficient of Variation 53 |
| All NEMI | Trough Concentration Following Administration of NEMI | Day 1,24 hour, n=8,2 | 313.9 Picograms per milliliter | Geometric Coefficient of Variation 61 |
| All NEMI | Trough Concentration Following Administration of NEMI | Day 84,pre-dose,n=11,7 | 1058.2 Picograms per milliliter | Geometric Coefficient of Variation 33 |
| All NEMI | Trough Concentration Following Administration of NEMI | Day 1,24 hour, n=8,2 | NA Picograms per milliliter | — |
| All NEMI | Trough Concentration Following Administration of NEMI | Day 12,pre-dose,n=9,5 | 1077.2 Picograms per milliliter | Geometric Coefficient of Variation 23 |
| All NEMI | Trough Concentration Following Administration of NEMI | Day 28,pre-dose, n=9,7 | 1225.8 Picograms per milliliter | Geometric Coefficient of Variation 50 |
| All NEMI | Trough Concentration Following Administration of NEMI | Day 56,pre-dose,n=11,7 | 1171.6 Picograms per milliliter | Geometric Coefficient of Variation 49 |