Asthma
Conditions
Keywords
Fluticasone furoate/vilanterol, Asthma, fraction of exhaled nitric oxide, cross-over
Brief summary
For asthmatic subjects, a combination of inhaled corticosteroid (FF) and long-acting beta2 receptor agonist (VI) is recommended for use (once daily) and fraction of exhaled nitric oxide (FeNO) is a non-invasive airway inflammation marker. In this randomised, double blind, placebo-controlled, two-period, crossover repeat dose study, the duration of action of fluticasone furoate (FF) will be determined by monitoring the return of FeNO levels to baseline, following the treatment with FF/vilanetrol (VI) in asthmatic subjects. Subjects who meet the eligibility criteria will participate in the following two treatment periods: FF/VI 100/25 mcg once-daily and placebo once-daily. Approximately 28 subjects will be enrolled in order to achieve 24 evaluable subjects. A 2-week treatment period will be followed by a 21-day monitoring/washout period before crossing over to the next treatment period. Total duration of each subject will be a maximum of 21 weeks. FeNO will be monitored up to 21 days after treatment with FF/VI together with FEV1 (up to 7 days).
Interventions
DRUGFluticasone furoate (FF) (100 mcg)
First blister strip contains FF blended with lactose, 100 mcg per blister
DRUGVilanterol (VI) (25 mcg)
Second blister strip contains vilanterol blended with lactose and magnesium stearate, 25 mcg per blister
DRUGPlacebo
Matching placebo will have two blister strips, identical in appearance to the inhaler containing active study medication; one containing lactose and the second strip containing lactose and magnesium stearate
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age of subject: Between 18 and 65 years of age inclusive, at the time of signing the informed consent. * A doctor diagnosis of asthma for at least 6 months prior to the start of the study. * Severity of disease: A screening pre-bronchodilator forced expiratory volume in one second (FEV1) \>=60% of predicted values, which will be based upon NHANES III * Reversibility of disease: Demonstrated presence of reversible airway disease at screening (repeat testing of eligibility can be undertaken following the screening visit up to Day -7) OR The presence of reversible airways disease can have been demonstrated historically within 6 months of the screening visit. Reversible airway disease is defined as increase in FEV1 of \>=12% over baseline and an absolute change of \>=200 mL within 30 minutes following 4 inhalations of albuterol/salbutamol inhalation aerosol/spacer (or equivalent nebulised treatment with albuterol/salbutamol solution). * Current Therapy: Short-acting beta2-agonists (SABA) prescribed for at least 12 weeks prior to screening. No inhaled corticosteroids (ICS), long-actint beta2-receptor agonist (LABA), long acting muscarinic anatagonist (LAMA), leukotriene receptor antagonist (LTRA) therapy for three months prior to the start of the study. * Non-smoker or ex-smoker (no smoking in previous 12 weeks, ≤10 pack years). * Screening and Day -7 AM fraction of inhaled nitric oxide (FeNO) values \> 40ppb. Both screening and Day -7 AM FeNO values for treatment Period 1 need to be \> 40ppb for the subject to be eligible. * Bodyweight and BMI: Bodyweight \>=50 kg and body mass index (BMI) within the range 18.0 40.0 kg/m2 (inclusive) * Male OR Female: * Females: A 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: Non-reproductive potential defined as: * Pre-menopausal females reporting one of the following: Tubal ligation Hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion Hysterectomy Bilateral Oophorectomy * Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone \[FSH\] and estradiol levels consistent with menopause \[refer to laboratory reference ranges for confirmatory levels\]). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. * Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication and until after the last dose of study medication and completion of the follow-up visit * 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
* A history of life-threatening asthma, which is defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures within the last 5 years * Other significant pulmonary diseases to include (but not limited to): pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities other than asthma. * Respiratory Infection: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of screening that led to a change in asthma management OR in the opinion of the Investigator, is expected to affect the subject's asthma status OR the subject's ability to participate in the study. However, subjects can be rescreened to allow for an adequate time period (of at least 4 weeks) between resolution of the infection and the date of randomisation. * Asthma Exacerbation: Any asthma exacerbation requiring oral corticosteroids within 12 weeks of screening or that resulted in overnight hospitalization requiring additional treatment for asthma within 6 months prior to screening. * Pre-defined concomitant medications and restrictions of nitrate-rich foods * Tobacco Use: Current smokers or a smoking history of \>=10 pack years. A subject may not have used any inhaled tobacco products in 12 weeks preceding the screening visit. * Previous Participation: Exposure to more than four new chemical entities within 12 months prior to the first dosing day. * Other concurrent Diseases/Abnormalities: A subject has any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the study results if the condition/disease exacerbated during the study. * The list of additional excluded conditions/diseases includes, but is not limited to the following: * Congestive heart failure-Known aortic aneurysm * Clinically significant coronary heart disease-Clinically significant cardiac arrhythmia * Stroke within 3 months of Visit 1-Uncontrolled hypertension * Recent or poorly controlled peptic ulcer-Haematologic, hepatic, or renal disease * Immunologic compromise-Current malignancy * Tuberculosis (current or untreated)-Cushing's disease * Addison's disease-Uncontrolled diabetes mellitus * Liver cirrhosis-Systemic Lupus Erythematosus * Uncontrolled thyroid disorder-Recent history of drug or alcohol abuse * Oropharyngeal examination: A subject will not be eligible if he/she has clinical visual evidence of oral candidiasis at screening. * Pregnancy and Lactating Females: * Pregnant females as determined by positive serum hCG test at screening or by positive urine hCG test prior to dosing. * Lactating females * Allergies: * Milk Protein Allergy: History of severe milk protein allergy. * Drug Allergy: Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the Dry Powder Inhaler (DPI) (i.e., lactose or magnesium stearate). * Historical Allergy: History of drug or other allergy that, in the opinion of investigator or GSK Medical Monitor, contraindicates their participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Baseline and up to Day 29 in each treatment period | FeNO is non-invasive marker of airway inflammation in asthma participants. It was measured by the participants, using Niox Vero device at AM (pre-dose) and PM on Day -7 and all way through Day 29 of each TP. The FeNO measurements were done over time following stop of repeat dose treatment with FF/VI. Change from Baseline was measured as ratio of post-dose visit value to Baseline value. Baseline was defined as Day 1(Pre-dose). Subject level Baseline defined as the mean of Baseline across periods for each participant. Period level Baseline defined as the difference between the Baseline and subject level Baseline for each period and each participant. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Summary of ratio from Baseline for exhaled nitric oxide reported as Geometric mean and Geometric coefficient of Variation. NA indicates data was not available. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in FeNO Over the FF/VI Treatment Period | Baseline and up to Day 29 in each treatment period | In participants with asthma the FeNO is a non-invasive marker of airway inflammation. The FeNO was measured by the participants AM (pre-dose) and PM on Day -7 and all the way through Day 29 of each treatment period. The measurements were recorded using Niox Vero device provided at the site. These FeNO measurements were done throughout the treatment period. Change from Baseline was measured by the value at post-dose visit minus the Baseline value. Baseline was defined as Day 1(Pre-dose). Subject level Baseline is defined as the mean of Baseline across periods for each participant. Period level Baseline is defined as the difference between the Baseline and subject level Baseline for each period and each participant. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data was not available. |
| Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Baseline and up to Day 29 in TP1; Baseline and up to follow up (Day 29) in TP2 | The PEF is a lung function evaluation assessed using a PEF meter. It was defined as the maximum amount of air exhaled during forced exhalation with lungs fully inflated. For PEF measurements the best of the 3 recordings were recorded AM and PM (i.e every 12 hours), from Day-7 through to Day 29 of TP1, and then from Day 1 of TP2 through to the (29). Change from Baseline was measured by the value at post-dose visit minus the Baseline value. Baseline was defined as Day 1(Pre-dose). Subject level Baseline is defined as the mean of Baseline across periods for each participant. Period level Baseline is defined as the difference between the Baseline and subject level Baseline for each period and each participant. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data was not available. |
| Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Pre-treatment and for up to 7 Days After Cessation of Repeat Dose Treatment With FF/VI | Baseline every morning and evening until Day 21 of each treatment period | FEV1 is defined as the maximal amount of air which can be exhaled forcefully in one second. Three technically acceptable FEV1 measurements were made using a spirometer, and were measured on pre-dose on Day 1, taken pre-dose on Day 14 and every morning and evening until Day 19, and in the morning on Day 21. Change from Baseline was measured by the value at post-dose visit minus the Baseline value. Baseline was defined as Day 1(Pre-dose). Subject level Baseline is defined as the mean of Baseline across periods for each participant. Period level Baseline is defined as the difference between the Baseline and subject level Baseline for each period and each participant. |
Countries
New Zealand
Participant flow
Recruitment details
This was a randomized, double blind, placebo-controlled, two-period, crossover repeat dose study in adult participants with asthma. The study was conducted from 29 April 2016 to 21 February 2017, at a single site in New Zealand.
Pre-assignment details
Total 36 participants were screened, of which 8 participants were screen failures. Of the 28 participants who were enrolled in the study, 27 participants were randomized as 1 participant withdrew before randomization. The study had Run-in period of 7 days, which was followed by a Treatment period (TP) 1, a wash-out period of 21 days and TP2.
Participants by arm
| Arm | Count |
|---|---|
| Total (Placebo+FF/VI 100/25mcg) In this two-period crossover study, participants received FF/VI 100/25 mcg or matching placebo through DPI once daily in each morning for 14 days either in TP 1 or TP 2 as per randomization schedule. There was a 21-days monitoring/washout period between two treatments during which participants were allowed to take rescue medication if required. Participants with any upper respiratory disorders including allergic rhinitis (both seasonal and perennial) and chronic rhinosinusitis (with or without nasal polyps), any participant who was on chronic maintenance therapies for these conditions were continued on their current standard of care medications (intranasal corticosteroids, antihistamines, cromones) throughout the entire duration of the study. | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | Total (Placebo+FF/VI 100/25mcg) |
|---|---|
| Age, Continuous | 24.5 Years STANDARD_DEVIATION 8.14 |
| Race/Ethnicity, Customized Asian and White | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiin or other Pacific Islander and White | 5 Participants |
| Race/Ethnicity, Customized White | 21 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 27 |
| other Total, other adverse events | 10 / 27 | 14 / 27 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 |
Outcome results
Primary
Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI
FeNO is non-invasive marker of airway inflammation in asthma participants. It was measured by the participants, using Niox Vero device at AM (pre-dose) and PM on Day -7 and all way through Day 29 of each TP. The FeNO measurements were done over time following stop of repeat dose treatment with FF/VI. Change from Baseline was measured as ratio of post-dose visit value to Baseline value. Baseline was defined as Day 1(Pre-dose). Subject level Baseline defined as the mean of Baseline across periods for each participant. Period level Baseline defined as the difference between the Baseline and subject level Baseline for each period and each participant. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Summary of ratio from Baseline for exhaled nitric oxide reported as Geometric mean and Geometric coefficient of Variation. NA indicates data was not available.
Time frame: Baseline and up to Day 29 in each treatment period
Population: The Pharmacodynamic (PD) Population consisted of all the participants from the All Subject population who had at least one PD assessment.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 1, AM (n=27,27) | 1.042 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 31.5499 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 14, AM (n=26,27) | 1.008 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 45.5319 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 7, AM (n=27,27) | 0.826 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 31.4676 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 14, PM (n=25,26) | 0.955 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 45.5768 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 3, PM (n=27,27) | 0.922 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 23.6705 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 15, AM (n=26,26) | 0.977 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 51.5523 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 7, PM (n=25,25) | 0.774 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 32.7473 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 15, PM (n=25,25) | 0.940 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 42.366 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 2, AM (n=27,27) | 1.012 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 27.3017 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 8, AM (n=25,27) | 0.830 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 40.7773 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 16, PM (n=26,27) | 1.019 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 38.169 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 4, AM (n=27,27) | 1.007 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 34.9235 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 17, AM (n=25,26) | 1.049 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 40.1495 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 8, PM (n=27,26) | 0.834 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 30.403 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 17, PM (n=18,16) | 0.967 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 38.4731 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 16, AM (n=26,27) | 1.029 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 51.1876 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 18, AM (n=17,14) | 0.935 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 39.0474 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 9, AM (n=27,27) | 0.935 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 35.7583 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 18, PM (n=14,10) | 0.926 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 39.247 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 4, PM (n=27,27) | 0.857 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 23.7972 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 19, AM (n=14,10) | 1.015 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 42.225 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 9, PM (n=27,27) | 0.924 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 32.1314 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 19, PM (n=12,6) | 0.911 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 30.6911 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 10, AM (n=24,26) | 1.022 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 34.474 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 20, AM (n=12,6) | 0.958 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 43.0056 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 2, PM (n=27,27) | 0.957 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 26.3328 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 20, PM (n=7,5) | 0.828 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 39.6562 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 10, PM (n=27,27) | 0.989 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 35.1066 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 21, AM (n=7,6) | 0.892 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 35.8531 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 5, AM (n=27,27) | 0.834 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 24.4572 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 21, PM (n=7,5) | 0.934 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 40.4076 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 11, AM (n=26,26) | 1.092 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 37.7142 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 22, AM (n=6,5) | 0.845 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 45.8754 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 5, PM (n=26,26) | 0.734 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 27.1308 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 22, PM (n=6,5) | 0.822 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 43.0801 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 11, PM (n=27,27) | 1.029 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 28.6618 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 23, AM (n=7,5) | 0.925 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 51.4896 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 1, PM (n=27,27) | 0.985 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 26.4785 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 23, PM (n=2,1) | 0.898 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 116.9108 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 12, AM (n=27,27) | 1.028 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 29.9667 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 24, AM (n=2,1) | 0.914 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 130.0375 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 6, AM (n=26,26) | 0.794 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 31.5924 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 24, PM (n=1,1) | 0.671 Ratio of exhaled Nitric Oxide | — |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 12, PM (n=27,27) | 1.004 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 28.5673 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 25, AM (n=1,0) | 0.548 Ratio of exhaled Nitric Oxide | — |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 3, AM (n=27,27) | 0.987 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 24.6102 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 13, AM (n=27,25) | 1.068 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 34.009 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 6, PM (n=24,26) | 0.783 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 30.82 |
| Placebo | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 13, PM (n=25,25) | 0.955 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 40.2945 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 28, AM (n=0,1) | 1.044 Ratio of exhaled Nitric Oxide | — |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 28, PM (n=0,1) | 0.767 Ratio of exhaled Nitric Oxide | — |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 29, AM (n=0,1) | 0.911 Ratio of exhaled Nitric Oxide | — |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 13, AM (n=27,25) | 0.744 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 38.4939 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 9, PM (n=27,27) | 0.607 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 46.3872 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 1, AM (n=27,27) | 0.371 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 47.3672 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 1, PM (n=27,27) | 0.321 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 51.5233 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 2, AM (n=27,27) | 0.373 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 71.6824 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 2, PM (n=27,27) | 0.346 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 52.6225 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 3, AM (n=27,27) | 0.442 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 60.8203 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 3, PM (n=27,27) | 0.417 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 51.1903 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 4, AM (n=27,27) | 0.536 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 60.5532 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 4, PM (n=27,27) | 0.484 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 48.1593 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 5, PM (n=26,26) | 0.473 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 46.6144 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 6, AM (n=26,26) | 0.525 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 50.7361 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 6, PM (n=24,26) | 0.470 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 43.8128 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 7, AM (n=27,27) | 0.484 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 49.0454 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 7, PM (n=25,25) | 0.487 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 49.9617 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 8, AM (n=25,27) | 0.554 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 47.5854 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 8, PM (n=27,26) | 0.545 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 42.1101 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 9, AM (n=27,27) | 0.594 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 45.0429 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 10, AM (n=24,26) | 0.658 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 41.371 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 10, PM (n=27,27) | 0.660 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 41.4832 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 11, AM (n=26,26) | 0.756 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 40.9942 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 11, PM (n=27,27) | 0.723 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 45.9281 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 12, AM (n=27,27) | 0.717 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 42.8654 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 12, PM (n=27,27) | 0.691 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 43.1839 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 5, AM (n=27,27) | 0.515 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 53.5926 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 13, PM (n=25,25) | 0.739 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 39.5506 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 14, AM (n=26,27) | 0.770 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 43.7613 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 14, PM (n=25,26) | 0.634 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 76.0516 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 15, AM (n=26,26) | 0.731 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 40.4602 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 15, PM (n=25,25) | 0.700 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 48.1949 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 16, AM (n=26,27) | 0.727 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 44.7703 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 16, PM (n=26,27) | 0.718 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 50.7656 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 17, AM (n=25,26) | 0.770 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 44.332 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 17, PM (n=18,16) | 0.765 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 59.4286 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 18, AM (n=17,14) | 0.724 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 54.2082 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 18, PM (n=14,10) | 0.619 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 58.6249 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 19, AM (n=14,10) | 0.722 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 51.2962 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 19, PM (n=12,6) | 0.571 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 48.191 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 20, AM (n=12,6) | 0.667 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 45.5449 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 20, PM (n=7,5) | 0.588 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 54.7676 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 21, AM (n=7,6) | 0.743 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 54.875 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 21, PM (n=7,5) | 0.637 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 63.2223 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 22, AM (n=6,5) | 0.705 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 82.0353 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 22, PM (n=6,5) | 0.622 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 75.8988 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 23, AM (n=7,5) | 0.749 Ratio of exhaled Nitric Oxide | Geometric Coefficient of Variation 76.0176 |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 23, PM (n=2,1) | 1.000 Ratio of exhaled Nitric Oxide | — |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 24, AM (n=2,1) | 1.144 Ratio of exhaled Nitric Oxide | — |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 24, PM (n=1,1) | 0.911 Ratio of exhaled Nitric Oxide | — |
| FF/VI 100/25mcg | Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI | Day 26, PM (n=0,1) | 0.989 Ratio of exhaled Nitric Oxide | — |
95% CI: [0.61, 0.86]
95% CI: [0.61, 0.86]
95% CI: [0.61, 0.85]
95% CI: [0.58, 0.81]
95% CI: [0.31, 0.43]
95% CI: [0.28, 0.39]
95% CI: [0.32, 0.45]
95% CI: [0.31, 0.44]
95% CI: [0.39, 0.54]
95% CI: [0.4, 0.56]
95% CI: [0.47, 0.66]
95% CI: [0.49, 0.69]
95% CI: [0.53, 0.75]
95% CI: [0.57, 0.8]
95% CI: [0.56, 0.8]
95% CI: [0.52, 0.74]
95% CI: [0.51, 0.71]
Comparison: Ratio of FF/VI 100/25mcg Vs Placebo for Day 8, AM95% CI: [0.52, 0.74]
95% CI: [0.58, 0.81]
95% CI: [0.57, 0.8]
95% CI: [0.56, 0.78]
95% CI: [0.57, 0.8]
95% CI: [0.55, 0.78]
95% CI: [0.6, 0.84]
95% CI: [0.61, 0.86]
95% CI: [0.66, 0.93]
95% CI: [0.66, 0.93]
95% CI: [0.56, 0.79]
95% CI: [0.66, 0.93]
95% CI: [0.66, 0.94]
95% CI: [0.62, 0.87]
95% CI: [0.61, 0.86]
95% CI: [0.65, 0.91]
95% CI: [0.65, 1.01]
95% CI: [0.61, 0.96]
95% CI: [0.59, 1]
95% CI: [0.63, 1.05]
95% CI: [0.52, 1]
95% CI: [0.56, 1.09]
95% CI: [0.53, 1.14]
95% CI: [0.59, 1.22]
95% CI: [0.5, 1.13]
95% CI: [0.55, 1.25]
95% CI: [0.51, 1.16]
95% CI: [0.66, 1.49]
95% CI: [0.29, 1.51]
95% CI: [0.32, 1.64]
Secondary
Change From Baseline in FeNO Over the FF/VI Treatment Period
In participants with asthma the FeNO is a non-invasive marker of airway inflammation. The FeNO was measured by the participants AM (pre-dose) and PM on Day -7 and all the way through Day 29 of each treatment period. The measurements were recorded using Niox Vero device provided at the site. These FeNO measurements were done throughout the treatment period. Change from Baseline was measured by the value at post-dose visit minus the Baseline value. Baseline was defined as Day 1(Pre-dose). Subject level Baseline is defined as the mean of Baseline across periods for each participant. Period level Baseline is defined as the difference between the Baseline and subject level Baseline for each period and each participant. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data was not available.
Time frame: Baseline and up to Day 29 in each treatment period
Population: PD Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 13, PM (n=25,25) | -1.6 Parts per billion | Standard Deviation 38.12 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 7, AM (n=27,27) | -15.4 Parts per billion | Standard Deviation 24.26 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 14, AM (n=26,27) | 4.7 Parts per billion | Standard Deviation 45.42 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 3, AM (n=27,27) | -0.8 Parts per billion | Standard Deviation 25.07 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 14, PM (n=25,26) | -3.4 Parts per billion | Standard Deviation 42.26 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 1, PM (n=27,27) | -0.5 Parts per billion | Standard Deviation 24.55 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 15, AM (n=26,26) | -1.6 Parts per billion | Standard Deviation 47.88 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 8, AM (n=25,27) | -14.2 Parts per billion | Standard Deviation 30 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 15, PM (n=25,25) | -3.7 Parts per billion | Standard Deviation 49.33 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 3, PM (n=27,27) | -7.9 Parts per billion | Standard Deviation 21.18 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 16, AM (n=26,27) | 3.7 Parts per billion | Standard Deviation 48 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 8, PM (n=27,26) | -15.3 Parts per billion | Standard Deviation 24.7 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 16, PM (n=26,27) | 4.5 Parts per billion | Standard Deviation 37.4 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 17, AM (n=25,26) | 6.1 Parts per billion | Standard Deviation 42.81 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 6, AM (n=26,26) | -17.6 Parts per billion | Standard Deviation 24.37 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 17, PM (n=18,16) | -8.5 Parts per billion | Standard Deviation 29.54 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 18, AM (n=17,14) | -7.5 Parts per billion | Standard Deviation 32.1 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 9, AM (n=27,27) | -5.7 Parts per billion | Standard Deviation 29.23 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 18, PM (n=14,10) | -6.2 Parts per billion | Standard Deviation 23.93 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 4, AM (n=27,27) | 1.2 Parts per billion | Standard Deviation 33.27 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 19, AM (n=14,10) | -2.8 Parts per billion | Standard Deviation 27.47 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 9, PM (n=27,27) | -5.3 Parts per billion | Standard Deviation 23.53 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 19, PM (n=12,6) | -9.3 Parts per billion | Standard Deviation 24.19 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 2, AM (n=27,27) | 1.3 Parts per billion | Standard Deviation 27.67 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 20, AM (n=12,6) | 0.1 Parts per billion | Standard Deviation 27.71 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 10, AM (n=24,26) | 4.1 Parts per billion | Standard Deviation 27.86 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 20, PM (n=7,5) | -8.7 Parts per billion | Standard Deviation 21.68 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 24, AM (n=2,1) | 2.0 Parts per billion | Standard Deviation 59.4 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 7, PM (n=25,25) | -19.9 Parts per billion | Standard Deviation 25.92 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 21, AM (n=7,6) | -6.6 Parts per billion | Standard Deviation 24.08 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 10, PM (n=27,27) | 3.8 Parts per billion | Standard Deviation 28.99 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 21, PM (n=7,5) | -3.0 Parts per billion | Standard Deviation 25.83 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 5, AM (n=27,27) | -15.3 Parts per billion | Standard Deviation 22.49 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 22, AM (n=6,5) | -7.5 Parts per billion | Standard Deviation 27.54 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 11, AM (n=26,26) | 12.8 Parts per billion | Standard Deviation 31.82 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 22, PM (n=6,5) | -11.5 Parts per billion | Standard Deviation 27.52 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 1, AM (n=27,27) | 1.9 Parts per billion | Standard Deviation 24.39 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 23, AM (n=7,5) | -0.6 Parts per billion | Standard Deviation 29.53 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 11, PM (n=27,27) | 6.2 Parts per billion | Standard Deviation 34.03 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 23, PM (n=2,1) | -0.5 Parts per billion | Standard Deviation 54.45 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 5, PM (n=26,26) | -22.1 Parts per billion | Standard Deviation 19.45 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 12, AM (n=27,27) | 3.1 Parts per billion | Standard Deviation 24.79 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 24, PM (n=1,1) | -24.0 Parts per billion | — |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 2, PM (n=27,27) | -3.1 Parts per billion | Standard Deviation 24.64 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 25, AM (n=1,0) | -33.0 Parts per billion | — |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 12, PM (n=27,27) | 1.3 Parts per billion | Standard Deviation 25.08 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 6, PM (n=24,26) | -19.4 Parts per billion | Standard Deviation 25.76 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 13, AM (n=27,25) | 8.3 Parts per billion | Standard Deviation 35.47 |
| Placebo | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 4, PM (n=27,27) | -11.6 Parts per billion | Standard Deviation 17.93 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 28, AM (n=0,1) | 4.0 Parts per billion | — |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 28, PM (n=0,1) | -21.0 Parts per billion | — |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 6, AM (n=26,26) | -47.1 Parts per billion | Standard Deviation 42.19 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 29, AM (n=0,1) | -8.0 Parts per billion | — |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 4, AM (n=27,27) | -48.6 Parts per billion | Standard Deviation 50.54 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 16, PM (n=26,27) | -26.6 Parts per billion | Standard Deviation 43.37 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 17, PM (n=18,16) | -19.6 Parts per billion | Standard Deviation 48.58 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 1, AM (n=27,27) | -63.3 Parts per billion | Standard Deviation 45.47 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 1, PM (n=27,27) | -68.5 Parts per billion | Standard Deviation 49.07 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 2, AM (n=27,27) | -63.5 Parts per billion | Standard Deviation 53.63 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 2, PM (n=27,27) | -66.1 Parts per billion | Standard Deviation 48.26 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 3, AM (n=27,27) | -56.6 Parts per billion | Standard Deviation 53.97 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 3, PM (n=27,27) | -59.8 Parts per billion | Standard Deviation 47.32 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 4, PM (n=27,27) | -51.5 Parts per billion | Standard Deviation 42.12 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 5, AM (n=27,27) | -48.9 Parts per billion | Standard Deviation 47.09 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 5, PM (n=26,26) | -54.0 Parts per billion | Standard Deviation 45 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 6, PM (n=24,26) | -54.0 Parts per billion | Standard Deviation 43.96 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 7, AM (n=27,27) | -50.0 Parts per billion | Standard Deviation 43.19 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 7, PM (n=25,25) | -46.4 Parts per billion | Standard Deviation 42.73 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 8, AM (n=25,27) | -42.7 Parts per billion | Standard Deviation 44.14 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 8, PM (n=27,26) | -46.1 Parts per billion | Standard Deviation 40.39 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 9, AM (n=27,27) | -40.1 Parts per billion | Standard Deviation 37.45 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 9, PM (n=27,27) | -38.7 Parts per billion | Standard Deviation 40.36 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 10, AM (n=24,26) | -31.6 Parts per billion | Standard Deviation 31.5 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 10, PM (n=27,27) | -32.8 Parts per billion | Standard Deviation 37.47 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 11, AM (n=26,26) | -23.8 Parts per billion | Standard Deviation 39.65 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 11, PM (n=27,27) | -26.4 Parts per billion | Standard Deviation 41.33 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 12, AM (n=27,27) | -25.7 Parts per billion | Standard Deviation 36.64 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 12, PM (n=27,27) | -29.4 Parts per billion | Standard Deviation 37.19 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 13, AM (n=27,25) | -23.3 Parts per billion | Standard Deviation 30.09 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 13, PM (n=25,25) | -26.2 Parts per billion | Standard Deviation 39.97 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 14, AM (n=26,27) | -23.5 Parts per billion | Standard Deviation 38.84 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 14, PM (n=25,26) | -30.9 Parts per billion | Standard Deviation 43.69 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 15, AM (n=26,26) | -25.8 Parts per billion | Standard Deviation 37.76 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 15, PM (n=25,25) | -27.9 Parts per billion | Standard Deviation 43.14 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 16, AM (n=26,27) | -26.7 Parts per billion | Standard Deviation 43.16 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 17, AM (n=25,26) | -20.9 Parts per billion | Standard Deviation 39.31 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 18, AM (n=17,14) | -27.3 Parts per billion | Standard Deviation 44.36 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 18, PM (n=14,10) | -38.3 Parts per billion | Standard Deviation 42.9 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 19, AM (n=14,10) | -30.7 Parts per billion | Standard Deviation 50.03 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 19, PM (n=12,6) | -52.2 Parts per billion | Standard Deviation 49.82 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 20, AM (n=12,6) | -40.2 Parts per billion | Standard Deviation 46.27 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 20, PM (n=7,5) | -59.0 Parts per billion | Standard Deviation 63.82 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 21, AM (n=7,6) | -32.7 Parts per billion | Standard Deviation 56.23 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 21, PM (n=7,5) | -51.2 Parts per billion | Standard Deviation 58.37 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 22, AM (n=6,5) | -37.0 Parts per billion | Standard Deviation 66.25 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 22, PM (n=6,5) | -51.8 Parts per billion | Standard Deviation 63.96 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 23, AM (n=7,5) | -37.0 Parts per billion | Standard Deviation 71.04 |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 23, PM (n=2,1) | 0.0 Parts per billion | — |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 24, AM (n=2,1) | 13.0 Parts per billion | — |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 24, PM (n=1,1) | -8.0 Parts per billion | — |
| FF/VI 100/25mcg | Change From Baseline in FeNO Over the FF/VI Treatment Period | Day 26, PM (n=0,1) | -1.0 Parts per billion | — |
Secondary
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Pre-treatment and for up to 7 Days After Cessation of Repeat Dose Treatment With FF/VI
FEV1 is defined as the maximal amount of air which can be exhaled forcefully in one second. Three technically acceptable FEV1 measurements were made using a spirometer, and were measured on pre-dose on Day 1, taken pre-dose on Day 14 and every morning and evening until Day 19, and in the morning on Day 21. Change from Baseline was measured by the value at post-dose visit minus the Baseline value. Baseline was defined as Day 1(Pre-dose). Subject level Baseline is defined as the mean of Baseline across periods for each participant. Period level Baseline is defined as the difference between the Baseline and subject level Baseline for each period and each participant.
Time frame: Baseline every morning and evening until Day 21 of each treatment period
Population: PD Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Pre-treatment and for up to 7 Days After Cessation of Repeat Dose Treatment With FF/VI | Day 3,AM | 0.084 Liter | Standard Deviation 0.3668 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Pre-treatment and for up to 7 Days After Cessation of Repeat Dose Treatment With FF/VI | Day 21, AM | 0.082 Liter | Standard Deviation 0.321 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Pre-treatment and for up to 7 Days After Cessation of Repeat Dose Treatment With FF/VI | Day 2,PM | 0.200 Liter | Standard Deviation 0.3902 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Pre-treatment and for up to 7 Days After Cessation of Repeat Dose Treatment With FF/VI | Day 2, AM | 0.073 Liter | Standard Deviation 0.3953 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Pre-treatment and for up to 7 Days After Cessation of Repeat Dose Treatment With FF/VI | Day 3,PM | 0.213 Liter | Standard Deviation 0.384 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Pre-treatment and for up to 7 Days After Cessation of Repeat Dose Treatment With FF/VI | Day 4, PM | 0.221 Liter | Standard Deviation 0.4187 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Pre-treatment and for up to 7 Days After Cessation of Repeat Dose Treatment With FF/VI | Day 5, AM | 0.197 Liter | Standard Deviation 0.3375 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Pre-treatment and for up to 7 Days After Cessation of Repeat Dose Treatment With FF/VI | Day 1, PM | 0.180 Liter | Standard Deviation 0.3105 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Pre-treatment and for up to 7 Days After Cessation of Repeat Dose Treatment With FF/VI | Day 7, AM | 0.124 Liter | Standard Deviation 0.3753 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Pre-treatment and for up to 7 Days After Cessation of Repeat Dose Treatment With FF/VI | Day 4, AM | 0.092 Liter | Standard Deviation 0.387 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Pre-treatment and for up to 7 Days After Cessation of Repeat Dose Treatment With FF/VI | Day 1, AM | 0.036 Liter | Standard Deviation 0.4169 |
| FF/VI 100/25mcg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Pre-treatment and for up to 7 Days After Cessation of Repeat Dose Treatment With FF/VI | Day 21, AM | 0.004 Liter | Standard Deviation 0.267 |
| FF/VI 100/25mcg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Pre-treatment and for up to 7 Days After Cessation of Repeat Dose Treatment With FF/VI | Day 1, AM | 0.361 Liter | Standard Deviation 0.3135 |
| FF/VI 100/25mcg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Pre-treatment and for up to 7 Days After Cessation of Repeat Dose Treatment With FF/VI | Day 1, PM | 0.383 Liter | Standard Deviation 0.3151 |
| FF/VI 100/25mcg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Pre-treatment and for up to 7 Days After Cessation of Repeat Dose Treatment With FF/VI | Day 2, AM | 0.331 Liter | Standard Deviation 0.2739 |
| FF/VI 100/25mcg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Pre-treatment and for up to 7 Days After Cessation of Repeat Dose Treatment With FF/VI | Day 3,AM | 0.271 Liter | Standard Deviation 0.2967 |
| FF/VI 100/25mcg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Pre-treatment and for up to 7 Days After Cessation of Repeat Dose Treatment With FF/VI | Day 3,PM | 0.319 Liter | Standard Deviation 0.3256 |
| FF/VI 100/25mcg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Pre-treatment and for up to 7 Days After Cessation of Repeat Dose Treatment With FF/VI | Day 4, PM | 0.301 Liter | Standard Deviation 0.3163 |
| FF/VI 100/25mcg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Pre-treatment and for up to 7 Days After Cessation of Repeat Dose Treatment With FF/VI | Day 2,PM | 0.369 Liter | Standard Deviation 0.3166 |
| FF/VI 100/25mcg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Pre-treatment and for up to 7 Days After Cessation of Repeat Dose Treatment With FF/VI | Day 4, AM | 0.241 Liter | Standard Deviation 0.2913 |
| FF/VI 100/25mcg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Pre-treatment and for up to 7 Days After Cessation of Repeat Dose Treatment With FF/VI | Day 5, AM | 0.207 Liter | Standard Deviation 0.2498 |
| FF/VI 100/25mcg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Pre-treatment and for up to 7 Days After Cessation of Repeat Dose Treatment With FF/VI | Day 7, AM | 0.102 Liter | Standard Deviation 0.3317 |
95% CI: [0.26, 0.46]
95% CI: [0.16, 0.36]
95% CI: [0.24, 0.44]
95% CI: [0.14, 0.34]
95% CI: [0.16, 0.36]
95% CI: [0.08, 0.28]
95% CI: [0.14, 0.34]
95% CI: [0.07, 0.27]
95% CI: [-0.03, 0.17]
95% CI: [-0.06, 0.14]
95% CI: [-0.07, 0.13]
Secondary
Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI
The PEF is a lung function evaluation assessed using a PEF meter. It was defined as the maximum amount of air exhaled during forced exhalation with lungs fully inflated. For PEF measurements the best of the 3 recordings were recorded AM and PM (i.e every 12 hours), from Day-7 through to Day 29 of TP1, and then from Day 1 of TP2 through to the (29). Change from Baseline was measured by the value at post-dose visit minus the Baseline value. Baseline was defined as Day 1(Pre-dose). Subject level Baseline is defined as the mean of Baseline across periods for each participant. Period level Baseline is defined as the difference between the Baseline and subject level Baseline for each period and each participant. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data was not available.
Time frame: Baseline and up to Day 29 in TP1; Baseline and up to follow up (Day 29) in TP2
Population: PD population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 10, PM (n=27,26) | -1.7 Liter per minute | Standard Deviation 84.64 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 8, PM (n=27,27) | 13.1 Liter per minute | Standard Deviation 61.79 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 4, PM (n=27,27) | 36.0 Liter per minute | Standard Deviation 85.62 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 11, PM (n=27,27) | 15.8 Liter per minute | Standard Deviation 76.76 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 12, AM (n=24,26) | -11.0 Liter per minute | Standard Deviation 83.14 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 21, AM (n=7,6) | -43.3 Liter per minute | Standard Deviation 56.85 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 12, PM (n=26,27) | -2.4 Liter per minute | Standard Deviation 71.17 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 5, AM (n=27,26) | 19.7 Liter per minute | Standard Deviation 61.28 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 13, AM (n=27,26) | -20.6 Liter per minute | Standard Deviation 77.5 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 24, AM (n=2,1) | -23.0 Liter per minute | Standard Deviation 25.46 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 13, PM (n=25,26) | 17.0 Liter per minute | Standard Deviation 104.76 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 5, PM (n=26,27) | 21.5 Liter per minute | Standard Deviation 75.94 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 14, AM (n=25,25) | -31.5 Liter per minute | Standard Deviation 77.48 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 1, AM (n=27,27) | -1.0 Liter per minute | Standard Deviation 67.11 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 14, PM (n=25,27) | -0.8 Liter per minute | Standard Deviation 76.69 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 15, AM (n=25,27) | -17.4 Liter per minute | Standard Deviation 59.88 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 6, AM (n=25,26) | -0.4 Liter per minute | Standard Deviation 69.89 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 15, PM (n=25,25) | -15.0 Liter per minute | Standard Deviation 67.65 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 11, AM (n=26,27) | -12.8 Liter per minute | Standard Deviation 74.84 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 16, AM (n=25,26) | -27.0 Liter per minute | Standard Deviation 66.7 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 6, PM (n=24,26) | 11.3 Liter per minute | Standard Deviation 75.26 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 16, PM (n=26,26) | -8.1 Liter per minute | Standard Deviation 74.86 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 2, AM (n=27,27) | 5.1 Liter per minute | Standard Deviation 61.5 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 17, AM (n=26,26) | -23.4 Liter per minute | Standard Deviation 73.32 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 7, AM (n=27,27) | 11.5 Liter per minute | Standard Deviation 71.97 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 17, PM (n=18,16) | 10.6 Liter per minute | Standard Deviation 86.6 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 24, PM (n=1,1) | -50.0 Liter per minute | — |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 18, AM (n=17,14) | -14.2 Liter per minute | Standard Deviation 79.96 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 7, PM (n=24,26) | 11.8 Liter per minute | Standard Deviation 75.33 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 18, PM (n=14,10) | -8.9 Liter per minute | Standard Deviation 90.25 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 8, AM (n=27,27) | -1.6 Liter per minute | Standard Deviation 73.8 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 19, AM (n=14,10) | -11.4 Liter per minute | Standard Deviation 91.61 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 3, AM (n=27,27) | 9.0 Liter per minute | Standard Deviation 58.49 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 19, PM (n=12,6) | 2.3 Liter per minute | Standard Deviation 102.76 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 20, AM (n=12,6) | -8.5 Liter per minute | Standard Deviation 81.09 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 25, AM (n=1,0) | -31.0 Liter per minute | — |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 20, PM (n=7,5) | -27.7 Liter per minute | Standard Deviation 46.03 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 9, AM (n=27,26) | -7.2 Liter per minute | Standard Deviation 80.69 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 3, PM (n=27,27) | 20.4 Liter per minute | Standard Deviation 69.1 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 21, PM (n=6,4) | -16.7 Liter per minute | Standard Deviation 73.86 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 9, PM (n=27,27) | 9.1 Liter per minute | Standard Deviation 73.71 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 22, AM (n=5,5) | -48.4 Liter per minute | Standard Deviation 40.28 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 2, PM (n=27,27) | 16.6 Liter per minute | Standard Deviation 74.02 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 22, PM (n=6,5) | -56.8 Liter per minute | Standard Deviation 46.23 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 10, AM (n=26,26) | -19.6 Liter per minute | Standard Deviation 76.63 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 23, AM (n=6,5) | -15.0 Liter per minute | Standard Deviation 50.62 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 4, AM (n=26,26) | 18.3 Liter per minute | Standard Deviation 61.63 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 23, PM (n=2,1) | -53.0 Liter per minute | Standard Deviation 1.41 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 1, PM (n=27,27) | 17.4 Liter per minute | Standard Deviation 69.59 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 22, AM (n=5,5) | -11.0 Liter per minute | Standard Deviation 103.22 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 22, PM (n=6,5) | -2.0 Liter per minute | Standard Deviation 91.29 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 23, AM (n=6,5) | 11.4 Liter per minute | Standard Deviation 53.62 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 23, PM (n=2,1) | 1.0 Liter per minute | — |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 1, PM (n=27,27) | 54.5 Liter per minute | Standard Deviation 63.23 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 7, PM (n=24,26) | 21.8 Liter per minute | Standard Deviation 55.7 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 11, PM (n=27,27) | -7.3 Liter per minute | Standard Deviation 63.12 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 14, PM (n=25,27) | -1.6 Liter per minute | Standard Deviation 58.26 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 19, PM (n=12,6) | 27.7 Liter per minute | Standard Deviation 61.49 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 24, AM (n=2,1) | 74.0 Liter per minute | — |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 24, PM (n=1,1) | 15.0 Liter per minute | — |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 28, AM (n=0,1) | -42.0 Liter per minute | — |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 29, AM (n=0,1) | 6.0 Liter per minute | — |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 26, PM (n=0,1) | -62.0 Liter per minute | — |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 27, AM (n=0,1) | 82.0 Liter per minute | — |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 1, AM (n=27,27) | 44.6 Liter per minute | Standard Deviation 55.54 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 2, AM (n=27,27) | 32.4 Liter per minute | Standard Deviation 55.35 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 2, PM (n=27,27) | 37.2 Liter per minute | Standard Deviation 53.42 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 3, AM (n=27,27) | 24.3 Liter per minute | Standard Deviation 58.56 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 3, PM (n=27,27) | 47.3 Liter per minute | Standard Deviation 52.8 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 4, AM (n=26,26) | 28.8 Liter per minute | Standard Deviation 54.42 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 4, PM (n=27,27) | 43.9 Liter per minute | Standard Deviation 56.01 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 5, AM (n=27,26) | 25.4 Liter per minute | Standard Deviation 49.86 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 5, PM (n=26,27) | 30.9 Liter per minute | Standard Deviation 49.67 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 6, AM (n=25,26) | 4.1 Liter per minute | Standard Deviation 61.63 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 6, PM (n=24,26) | 28.5 Liter per minute | Standard Deviation 52.75 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 7, AM (n=27,27) | 17.0 Liter per minute | Standard Deviation 55.89 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 8, AM (n=27,27) | 2.6 Liter per minute | Standard Deviation 51.94 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 8, PM (n=27,27) | 9.1 Liter per minute | Standard Deviation 56.68 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 9, AM (n=27,26) | -14.7 Liter per minute | Standard Deviation 74.06 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 9, PM (n=27,27) | -1.7 Liter per minute | Standard Deviation 58.12 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 10, AM (n=26,26) | -19.9 Liter per minute | Standard Deviation 68.55 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 10, PM (n=27,26) | 12.6 Liter per minute | Standard Deviation 52.16 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 11, AM (n=26,27) | -12.3 Liter per minute | Standard Deviation 56.24 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 12, AM (n=24,26) | -23.5 Liter per minute | Standard Deviation 64.35 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 12, PM (n=26,27) | -5.9 Liter per minute | Standard Deviation 66.19 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 13, AM (n=27,26) | -35.1 Liter per minute | Standard Deviation 67.19 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 13, PM (n=25,26) | -13.0 Liter per minute | Standard Deviation 61.78 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 14, AM (n=25,25) | -13.6 Liter per minute | Standard Deviation 65.25 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 15, AM (n=25,27) | -20.4 Liter per minute | Standard Deviation 58.86 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 15, PM (n=25,25) | -7.8 Liter per minute | Standard Deviation 64.72 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 16, AM (n=25,26) | -30.2 Liter per minute | Standard Deviation 75.78 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 16, PM (n=26,26) | 0.7 Liter per minute | Standard Deviation 60.72 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 17, AM (n=26,26) | -4.7 Liter per minute | Standard Deviation 65.85 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 17, PM (n=18,16) | 8.7 Liter per minute | Standard Deviation 62.33 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 18, AM (n=17,14) | 3.8 Liter per minute | Standard Deviation 71.5 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 18, PM (n=14,10) | 29.6 Liter per minute | Standard Deviation 64.62 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 19, AM (n=14,10) | -0.1 Liter per minute | Standard Deviation 70.24 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 20, AM (n=12,6) | -10.5 Liter per minute | Standard Deviation 71.92 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 20, PM (n=7,5) | 26.6 Liter per minute | Standard Deviation 49.22 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 21, AM (n=7,6) | 17.8 Liter per minute | Standard Deviation 78.2 |
| FF/VI 100/25mcg | Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI | Day 21, PM (n=6,4) | -19.8 Liter per minute | Standard Deviation 32.62 |
95% CI: [23.69, 68.03]
95% CI: [23.2, 67.55]
95% CI: [11.86, 56.21]
95% CI: [9.38, 53.73]
95% CI: [0.68, 45.03]
95% CI: [14.77, 59.12]
95% CI: [-3, 41.66]
95% CI: [-1.32, 43.03]
95% CI: [-5.47, 39.11]
95% CI: [-0.41, 44.14]
95% CI: [-9.57, 35.67]
95% CI: [5.38, 51.98]
95% CI: [-5.08, 39.26]
95% CI: [0.28, 46.94]
95% CI: [-9.3, 35.05]
95% CI: [-14.67, 29.68]
95% CI: [-19.11, 25.74]
95% CI: [-18.34, 26]
95% CI: [-11.11, 33.82]
95% CI: [5.43, 50.03]
95% CI: [-7.57, 36.98]
95% CI: [-28.8, 15.55]
95% CI: [-18.39, 27.11]
95% CI: [-13.99, 30.57]
95% CI: [-21.64, 22.92]
95% CI: [-29.96, 16.19]
95% CI: [5.76, 51.13]
95% CI: [-10.13, 34.74]
95% CI: [-18.16, 26.36]
95% CI: [-3.89, 41.63]
95% CI: [-16.17, 28.88]
95% CI: [-3.27, 41.41]
95% CI: [6.87, 52.15]
95% CI: [-17.91, 37.19]
95% CI: [-4.2, 53.73]
95% CI: [14.63, 79.45]
95% CI: [-12.3, 52.52]
95% CI: [-15.02, 65.27]
95% CI: [-48.04, 32.25]
95% CI: [-37.22, 54.25]
95% CI: [-28.5, 58.67]
95% CI: [-45.35, 55.73]