Asthma
Conditions
Keywords
HPA axis
Brief summary
The purpose of this study is to assess the effect of six weeks' treatment with two once-daily strengths of Fluticasone Furoate/GW642444 Inhalation Powder on the HPA axis system
Interventions
Placebo Inhalation powder inhaled once daily for 6 weeks' treatment
Dose B inhaled once daily for 6 weeks' treatment
DRUGPlacebo Oral Capsule
One placebo capsule taken each day on the last 7 days of the study
DRUGPrednisolone Oral Capsule
Prednisolone 10mg oral capsule taken each day on the last 7 days of the study
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Outpatient with ability to comply with study requirements and complete two 24-hour clinic visits * Clinical diagnosis of asthma for greater than/equal to 12 weeks * Reversibility FEV1 of at least twelve percent and two hundred milliliters * FEV1 greater than or equal to fifty percent of predicted
Exclusion criteria
* History of life threatening asthma * Respiratory infection or oral candidiasis * Asthma exacerbation * Uncontrolled disease or clinical abnormality * Allergies to study drugs, study drugs' excipients, medications related to study drugs * Taking another investigational medication or prohibited medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratio From Baseline of the Serum Cortisol Weighted Mean (0-24 Hours) on Day -1/1 (Baseline) and Day 42 | Day -1/1 (Baseline) and Day 42 | Serum cortisol weighted mean was determined for each participant over the time period 0-12 hours on Day -1/1 (Baseline) and Day 42. Serum cortisol weighted mean was derived by dividing the area under the concentration-time curve (AUC; defined as thearea under the concentration-time curve from time zero up to 24 hours) by the sample collection time interval. The sample collection time interval is defined as the difference between the time of the last cortisol sample and the time of the first cortisol sample. Samples were collected at the following time points: 0 (first blood draw/pre-dose); 2, 4, 9, 12, 14, 16, 20, 22, and 24 hours (relative to the 0 time point). Because values are on a logged scale, the ratio of the endpoint to Baseline is presented, as it is a measure of the difference from Baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ratio From Baseline of Serum Cortisol Trough (0-24 Hours) at Day -1/1 (Baseline) and Day 42 | Day -1/1 (Baseline) and Day 42 | Serum cortisol trough is defined as the minimum value of serum cortisol measured over the 24-hour period. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr. Because values are on a logged scale, the ratio of the endpoint to Baseline is presented, as it is a measure of the difference from Baseline. |
| Ratio From Baseline of 0-24 Hour Urinary Free Cortisol Excretion on Day -1/1 (Baseline) and Day 42 | Day -1/1 (Baseline) and Day 42 | A 24-hour urine sample was collected for the measurement of 24-hour urinary cortisol excretion at Day -1/1 (Baseline) and Day 42. Only those participants available at the specified time points were analyzed. Because values are on a logged scale, the ratio of the endpoint to Baseline is presented, as it is a measure of the difference from Baseline. |
| Plasma FF and VI Pharmacokinetic (PK) Concentration | Day 42 | Plasma FF and VI Pharmacokinetic (PK) Concentration were estimates at the following time points:0 (immediately pre-dose inhaled study drug), and post-dose at 5 min, 15 min, 30 min, and 1 hr, 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, 24 hr on Day 42. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Pharmacokinetic Population. |
| AUC(0-t) and AUC(0-24) for FF on Day 42 | Day 42 | Area under the plasma drug concentration-time (AUC\[0-t\]) curve from time zero (pre-dose) to the last time of quantifiable FF concentration and AUC(0-24) is the concentration time curve from zero (pre-dose) to 24 hours of quantifiable FF concentration on Day 42 was measured. AUC reflects the actual body exposure to drug over a specified period of time after administration of a dose. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42. |
| Cmax for FF on Day 42 | Day 42 | Cmax is defined as the maximum observed concentration on Day 42. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42. |
| Tmax and Tlast of FF at Day 42 | Day 42 | tmax is defined as the time to reach the observed maximum concentration, and tlast is defined as the time of the last observed quantifiable concentration on Day 42. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42. |
| AUC(0-t) for VI on Day 42 | Day 42 | Area under the concentration-time (AUC\[0-t\]) curve from time zero (pre-dose) to the last time of quantifiable VI concentration on Day 42 was measured. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42. |
| Cmax for VI on Day 42 | Day 42 | Cmax is defined as the maximum observed concentration on Day 42. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42. |
| Tmax and Tlast of VI at Day 42 | Day 42 | tmax is defined as the time to reach the observed maximum concentration, and tlast is defined as the time of the last observed quantifiable VI concentration on Day 42. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42. |
| Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | From the start of study medication until Day 42 (Visit 5)/Early Withdrawal | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs. |
| Ratio From Baseline of the Serum Cortisol Area Under the Concentration-time Curve (AUC) (0-24 Hour) on Day -1/1 (Baseline) and Day 42 | Day -1/1 (Baseline) and Day 42 | Area under the plasma drug concentration-time (AUC\[0-24 hour\]) curve from time zero (pre-dose) to the last time of quantifiable serum cortisol concentration at 24 hours post-dose on Day -1/1 (Baseline) and Day 42 was measured. AUC reflects the actual body exposure to drug over a specified period of time after administration of a dose. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr. Because values are on a logged scale, the ratio of the endpoint to Baseline is presented, as it is a measure of the difference from Baseline. |
| Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | Baseline and Day 42/EW | Blood samples were collected for the measurement of eosinophils, total neutrophils, platelets, and WBC count at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value. |
| Change From Baseline in Hemoglobin Values at Day 42/EW | Baseline and Day 42/EW | Blood samples were collected for the measurement of hemoglobin at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value. |
| Change From Baseline in Hematocrit Values at Day 42/EW | Baseline and Day 42/EW | Blood samples were collected for the measurement of hematocrit at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value. |
| Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | Baseline and Day 42/EW | Blood samples were collected for the measurement of ALT, ALP, AST, CK, and GGT at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value. |
| Change From Baseline in Albumin and Total Protein Values at Day 42/EW | Baseline and Day 42/EW | Blood samples were collected for the measurement of albumin and total protein at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value. |
| Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Baseline and Day 42/EW | Blood samples were collected for the measurement of direct bilirubin, indirect bilirubin, total bilirubin, and creatinine at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value. |
| Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Baseline and Day 42/EW | Blood samples were collected for the measurement of chloride, carbon dioxide (CO2) content/bicarbonate, glucose, potassium, sodium, and urea/blood urea nitrogen (BUN) at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value. |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | Days 14, 28, 42, and EW | SBP and DBP were measured at Baseline and at Days 14, 28, 42, and EW. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value. Scheduled, unscheduled, and early withdrawal visits were used for the maximum post-Baseline assessment. |
| Change From Baseline in Pulse Rate at Days 14, 28, 42, and Maximum Post-Baseline | Days 14, 28, 42, and EW | Heart rate was measured at Baseline and at Days 14, 28, 42, and EW. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value. Scheduled, unscheduled, and early withdrawal visits were used for the maximum post-Baseline assessment. |
| Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Baseline and Day 42/Early Withdrawal (EW) | Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and segmented neutrophils at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value. |
Countries
Germany, Poland, United States
Participant flow
Recruitment details
Participants who met all the inclusion criteria entered a 7- to 14-day Run-in Period (screening visit \[Visit 1\]). Participants were provided with albuterol/salbutamol inhalation aerosol for relief of asthma symptoms during the study.
Pre-assignment details
At the end of the Run-in Period, participants who meet the randomization criteria were admitted to the clinic in the evening (Visit 2) for the Baseline collection of 24-hour serial serum cortisol samples and urine. Eligible participants were randomly assigned to one of four treatment groups in a 4:4:4:1 ratio.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment. | 58 |
| FF/VI 100/25 µg PM Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment. | 56 |
| FF/VI 200/25 µg PM Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment. | 56 |
| Prednisolone 10 mg AM Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment. | 15 |
| Total | 185 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 2 |
| Overall Study | Lack of Efficacy | 1 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | FF/VI 100/25 µg PM | FF/VI 200/25 µg PM | Prednisolone 10 mg AM | Total |
|---|---|---|---|---|---|
| Age, Continuous | 36.1 Years STANDARD_DEVIATION 15.42 | 34.4 Years STANDARD_DEVIATION 15.63 | 34.0 Years STANDARD_DEVIATION 13.74 | 37.5 Years STANDARD_DEVIATION 14.19 | 35.1 Years STANDARD_DEVIATION 14.82 |
| Gender Female | 27 Participants | 31 Participants | 23 Participants | 6 Participants | 87 Participants |
| Gender Male | 31 Participants | 25 Participants | 33 Participants | 9 Participants | 98 Participants |
| Race/Ethnicity, Customized African American/African Heritage | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian - Japanese Heritage | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 55 Participants | 56 Participants | 53 Participants | 15 Participants | 179 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 | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 9 / 58 | 20 / 56 | 13 / 56 | 5 / 15 |
| serious Total, serious adverse events | 0 / 58 | 0 / 56 | 0 / 56 | 0 / 15 |
Outcome results
Primary
Ratio From Baseline of the Serum Cortisol Weighted Mean (0-24 Hours) on Day -1/1 (Baseline) and Day 42
Serum cortisol weighted mean was determined for each participant over the time period 0-12 hours on Day -1/1 (Baseline) and Day 42. Serum cortisol weighted mean was derived by dividing the area under the concentration-time curve (AUC; defined as thearea under the concentration-time curve from time zero up to 24 hours) by the sample collection time interval. The sample collection time interval is defined as the difference between the time of the last cortisol sample and the time of the first cortisol sample. Samples were collected at the following time points: 0 (first blood draw/pre-dose); 2, 4, 9, 12, 14, 16, 20, 22, and 24 hours (relative to the 0 time point). Because values are on a logged scale, the ratio of the endpoint to Baseline is presented, as it is a measure of the difference from Baseline.
Time frame: Day -1/1 (Baseline) and Day 42
Population: Serum Cortisol (SC) Population: all participants in the Intent-to-Treat Population who did not have protocol deviations that were considered to affect the SC endpoint and whose serum samples were not considered to have confounding factors affecting results interpretation. Only those participant available at the specified time points were analzyed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Ratio From Baseline of the Serum Cortisol Weighted Mean (0-24 Hours) on Day -1/1 (Baseline) and Day 42 | 0.99 ratio from Baseline | Geometric Coefficient of Variation 29.6 |
| FF/VI 100/25 µg PM | Ratio From Baseline of the Serum Cortisol Weighted Mean (0-24 Hours) on Day -1/1 (Baseline) and Day 42 | 0.99 ratio from Baseline | Geometric Coefficient of Variation 40 |
| FF/VI 200/25 µg PM | Ratio From Baseline of the Serum Cortisol Weighted Mean (0-24 Hours) on Day -1/1 (Baseline) and Day 42 | 0.96 ratio from Baseline | Geometric Coefficient of Variation 27.2 |
| Prednisolone 10 mg AM | Ratio From Baseline of the Serum Cortisol Weighted Mean (0-24 Hours) on Day -1/1 (Baseline) and Day 42 | 0.32 ratio from Baseline | Geometric Coefficient of Variation 72.9 |
95% CI: [0.87, 1.12]
95% CI: [0.86, 1.1]
95% CI: [0.28, 0.41]
Secondary
AUC(0-t) and AUC(0-24) for FF on Day 42
Area under the plasma drug concentration-time (AUC\[0-t\]) curve from time zero (pre-dose) to the last time of quantifiable FF concentration and AUC(0-24) is the concentration time curve from zero (pre-dose) to 24 hours of quantifiable FF concentration on Day 42 was measured. AUC reflects the actual body exposure to drug over a specified period of time after administration of a dose. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.
Time frame: Day 42
Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PK Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| FF/VI 100/25 µg PM | AUC(0-t) and AUC(0-24) for FF on Day 42 | AUC(0-t), n=54, 55 | 58.842 picograms*hour per milliliter (pg*hr/mL) |
| FF/VI 100/25 µg PM | AUC(0-t) and AUC(0-24) for FF on Day 42 | AUC(0-24), n=49, 53 | NA picograms*hour per milliliter (pg*hr/mL) |
| FF/VI 200/25 µg PM | AUC(0-t) and AUC(0-24) for FF on Day 42 | AUC(0-t), n=54, 55 | 221.694 picograms*hour per milliliter (pg*hr/mL) |
| FF/VI 200/25 µg PM | AUC(0-t) and AUC(0-24) for FF on Day 42 | AUC(0-24), n=49, 53 | 324.015 picograms*hour per milliliter (pg*hr/mL) |
Secondary
AUC(0-t) for VI on Day 42
Area under the concentration-time (AUC\[0-t\]) curve from time zero (pre-dose) to the last time of quantifiable VI concentration on Day 42 was measured. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.
Time frame: Day 42
Population: PK Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FF/VI 100/25 µg PM | AUC(0-t) for VI on Day 42 | 41.177 picograms*hour per milliliter (pg*hr/mL) | Standard Deviation 53.972 |
| FF/VI 200/25 µg PM | AUC(0-t) for VI on Day 42 | 66.937 picograms*hour per milliliter (pg*hr/mL) | Standard Deviation 142.3461 |
Secondary
Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW
Blood samples were collected for the measurement of ALT, ALP, AST, CK, and GGT at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.
Time frame: Baseline and Day 42/EW
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | ALT, Day 42, n=55, 51, 55, 12 | -1.3 International units per liter (IU/L) | Standard Deviation 13.05 |
| Placebo | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | ALT, EW, n=2, 2, 0, 0 | -5.0 International units per liter (IU/L) | Standard Deviation 8.49 |
| Placebo | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | ALP, Day 42, n=55, 51, 55, 12 | -6.8 International units per liter (IU/L) | Standard Deviation 11.06 |
| Placebo | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | ALP, EW, n=2, 2, 0, 0 | 1.5 International units per liter (IU/L) | Standard Deviation 9.19 |
| Placebo | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | AST, Day 42, n=54, 50, 51, 12 | -0.1 International units per liter (IU/L) | Standard Deviation 12.42 |
| Placebo | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | AST, EW, n=2, 2, 0, 0 | 0.5 International units per liter (IU/L) | Standard Deviation 0.71 |
| Placebo | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | CK, Day 42, n=55, 51, 55, 12 | -42.3 International units per liter (IU/L) | Standard Deviation 342.74 |
| Placebo | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | CK, EW, n=2, 2, 0, 0 | 15.0 International units per liter (IU/L) | Standard Deviation 21.21 |
| Placebo | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | GGT, Day 42, n=55, 51, 55, 12 | -3.3 International units per liter (IU/L) | Standard Deviation 10.65 |
| Placebo | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | GGT, EW, n=2, 2, 0, 0 | -2.5 International units per liter (IU/L) | Standard Deviation 6.36 |
| FF/VI 100/25 µg PM | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | ALP, Day 42, n=55, 51, 55, 12 | -2.1 International units per liter (IU/L) | Standard Deviation 13.96 |
| FF/VI 100/25 µg PM | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | GGT, Day 42, n=55, 51, 55, 12 | -2.5 International units per liter (IU/L) | Standard Deviation 6.94 |
| FF/VI 100/25 µg PM | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | ALP, EW, n=2, 2, 0, 0 | -1.0 International units per liter (IU/L) | Standard Deviation 1.41 |
| FF/VI 100/25 µg PM | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | AST, Day 42, n=54, 50, 51, 12 | -1.4 International units per liter (IU/L) | Standard Deviation 6.82 |
| FF/VI 100/25 µg PM | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | AST, EW, n=2, 2, 0, 0 | 0.0 International units per liter (IU/L) | Standard Deviation 1.41 |
| FF/VI 100/25 µg PM | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | CK, Day 42, n=55, 51, 55, 12 | -18.5 International units per liter (IU/L) | Standard Deviation 289.98 |
| FF/VI 100/25 µg PM | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | GGT, EW, n=2, 2, 0, 0 | -0.5 International units per liter (IU/L) | Standard Deviation 0.71 |
| FF/VI 100/25 µg PM | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | CK, EW, n=2, 2, 0, 0 | 33.0 International units per liter (IU/L) | Standard Deviation 73.54 |
| FF/VI 100/25 µg PM | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | ALT, Day 42, n=55, 51, 55, 12 | -2.0 International units per liter (IU/L) | Standard Deviation 8.49 |
| FF/VI 100/25 µg PM | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | ALT, EW, n=2, 2, 0, 0 | 0.5 International units per liter (IU/L) | Standard Deviation 2.12 |
| FF/VI 200/25 µg PM | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | CK, EW, n=2, 2, 0, 0 | NA International units per liter (IU/L) | — |
| FF/VI 200/25 µg PM | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | CK, Day 42, n=55, 51, 55, 12 | 5.5 International units per liter (IU/L) | Standard Deviation 67.57 |
| FF/VI 200/25 µg PM | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | GGT, EW, n=2, 2, 0, 0 | NA International units per liter (IU/L) | — |
| FF/VI 200/25 µg PM | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | ALT, Day 42, n=55, 51, 55, 12 | -2.2 International units per liter (IU/L) | Standard Deviation 10.86 |
| FF/VI 200/25 µg PM | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | ALP, EW, n=2, 2, 0, 0 | NA International units per liter (IU/L) | — |
| FF/VI 200/25 µg PM | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | AST, EW, n=2, 2, 0, 0 | NA International units per liter (IU/L) | — |
| FF/VI 200/25 µg PM | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | GGT, Day 42, n=55, 51, 55, 12 | 2.2 International units per liter (IU/L) | Standard Deviation 17.24 |
| FF/VI 200/25 µg PM | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | ALT, EW, n=2, 2, 0, 0 | NA International units per liter (IU/L) | — |
| FF/VI 200/25 µg PM | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | AST, Day 42, n=54, 50, 51, 12 | -0.6 International units per liter (IU/L) | Standard Deviation 6.91 |
| FF/VI 200/25 µg PM | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | ALP, Day 42, n=55, 51, 55, 12 | -2.6 International units per liter (IU/L) | Standard Deviation 8.33 |
| Prednisolone 10 mg AM | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | AST, Day 42, n=54, 50, 51, 12 | -1.8 International units per liter (IU/L) | Standard Deviation 5.67 |
| Prednisolone 10 mg AM | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | CK, EW, n=2, 2, 0, 0 | NA International units per liter (IU/L) | — |
| Prednisolone 10 mg AM | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | AST, EW, n=2, 2, 0, 0 | NA International units per liter (IU/L) | — |
| Prednisolone 10 mg AM | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | GGT, EW, n=2, 2, 0, 0 | NA International units per liter (IU/L) | — |
| Prednisolone 10 mg AM | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | CK, Day 42, n=55, 51, 55, 12 | -17.3 International units per liter (IU/L) | Standard Deviation 95.02 |
| Prednisolone 10 mg AM | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | ALT, EW, n=2, 2, 0, 0 | NA International units per liter (IU/L) | — |
| Prednisolone 10 mg AM | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | ALP, Day 42, n=55, 51, 55, 12 | -4.9 International units per liter (IU/L) | Standard Deviation 9.86 |
| Prednisolone 10 mg AM | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | ALP, EW, n=2, 2, 0, 0 | NA International units per liter (IU/L) | — |
| Prednisolone 10 mg AM | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | ALT, Day 42, n=55, 51, 55, 12 | 0.8 International units per liter (IU/L) | Standard Deviation 3.33 |
| Prednisolone 10 mg AM | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW | GGT, Day 42, n=55, 51, 55, 12 | 3.1 International units per liter (IU/L) | Standard Deviation 7.32 |
Secondary
Change From Baseline in Albumin and Total Protein Values at Day 42/EW
Blood samples were collected for the measurement of albumin and total protein at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.
Time frame: Baseline and Day 42/EW
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Albumin and Total Protein Values at Day 42/EW | Albumin, Day 42, n=55, 51, 55, 12 | -2.7 Grams per liter | Standard Deviation 3.29 |
| Placebo | Change From Baseline in Albumin and Total Protein Values at Day 42/EW | Albumin, EW, n=2, 2, 0, 0 | -1.5 Grams per liter | Standard Deviation 3.54 |
| Placebo | Change From Baseline in Albumin and Total Protein Values at Day 42/EW | Total Protein, Day 42, n=55, 51, 55, 12 | -4.1 Grams per liter | Standard Deviation 5.06 |
| Placebo | Change From Baseline in Albumin and Total Protein Values at Day 42/EW | Total Protein, EW, n=2, 2, 0, 0 | -0.5 Grams per liter | Standard Deviation 3.54 |
| FF/VI 100/25 µg PM | Change From Baseline in Albumin and Total Protein Values at Day 42/EW | Albumin, EW, n=2, 2, 0, 0 | 0.5 Grams per liter | Standard Deviation 2.12 |
| FF/VI 100/25 µg PM | Change From Baseline in Albumin and Total Protein Values at Day 42/EW | Total Protein, Day 42, n=55, 51, 55, 12 | -1.9 Grams per liter | Standard Deviation 4.39 |
| FF/VI 100/25 µg PM | Change From Baseline in Albumin and Total Protein Values at Day 42/EW | Total Protein, EW, n=2, 2, 0, 0 | 0.0 Grams per liter | Standard Deviation 0 |
| FF/VI 100/25 µg PM | Change From Baseline in Albumin and Total Protein Values at Day 42/EW | Albumin, Day 42, n=55, 51, 55, 12 | -1.5 Grams per liter | Standard Deviation 3.02 |
| FF/VI 200/25 µg PM | Change From Baseline in Albumin and Total Protein Values at Day 42/EW | Total Protein, Day 42, n=55, 51, 55, 12 | -1.8 Grams per liter | Standard Deviation 4.65 |
| FF/VI 200/25 µg PM | Change From Baseline in Albumin and Total Protein Values at Day 42/EW | Albumin, EW, n=2, 2, 0, 0 | NA Grams per liter | — |
| FF/VI 200/25 µg PM | Change From Baseline in Albumin and Total Protein Values at Day 42/EW | Total Protein, EW, n=2, 2, 0, 0 | NA Grams per liter | — |
| FF/VI 200/25 µg PM | Change From Baseline in Albumin and Total Protein Values at Day 42/EW | Albumin, Day 42, n=55, 51, 55, 12 | -1.3 Grams per liter | Standard Deviation 3.11 |
| Prednisolone 10 mg AM | Change From Baseline in Albumin and Total Protein Values at Day 42/EW | Total Protein, EW, n=2, 2, 0, 0 | NA Grams per liter | — |
| Prednisolone 10 mg AM | Change From Baseline in Albumin and Total Protein Values at Day 42/EW | Albumin, EW, n=2, 2, 0, 0 | NA Grams per liter | — |
| Prednisolone 10 mg AM | Change From Baseline in Albumin and Total Protein Values at Day 42/EW | Albumin, Day 42, n=55, 51, 55, 12 | -0.3 Grams per liter | Standard Deviation 2.81 |
| Prednisolone 10 mg AM | Change From Baseline in Albumin and Total Protein Values at Day 42/EW | Total Protein, Day 42, n=55, 51, 55, 12 | -0.8 Grams per liter | Standard Deviation 4.18 |
Secondary
Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW)
Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and segmented neutrophils at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.
Time frame: Baseline and Day 42/Early Withdrawal (EW)
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Monocytes, EW, n=2, 2, 0, 0 | -1.00 Percentage | Standard Deviation 0.424 |
| Placebo | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Basophils, EW, n=2, 2, 0, 0 | -0.10 Percentage | Standard Deviation 0.141 |
| Placebo | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Lymphocytes, Day 42, n=50, 47, 53, 11 | 1.09 Percentage | Standard Deviation 6.836 |
| Placebo | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Eosinophils, EW, n=2, 2, 0, 0 | 0.50 Percentage | Standard Deviation 0.849 |
| Placebo | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Monocytes, Day 42, n=50, 47, 53, 11 | -0.51 Percentage | Standard Deviation 2.074 |
| Placebo | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Basophils, Day 42, n=50, 47, 53, 11 | 0.05 Percentage | Standard Deviation 0.354 |
| Placebo | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Eosinophils, Day 42, n=50, 47, 53, 11 | 0.57 Percentage | Standard Deviation 2.837 |
| Placebo | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Segmented Neutrophils, EW, n=2, 2, 0, 0 | -2.30 Percentage | Standard Deviation 11.738 |
| Placebo | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Segmented Neutrophils, Day 42, n=50, 47, 53, 11 | -1.16 Percentage | Standard Deviation 8.291 |
| Placebo | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Lymphocytes, EW, n=2, 2, 0, 0 | 2.90 Percentage | Standard Deviation 10.607 |
| FF/VI 100/25 µg PM | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Monocytes, EW, n=2, 2, 0, 0 | -0.70 Percentage | Standard Deviation 3.111 |
| FF/VI 100/25 µg PM | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Basophils, Day 42, n=50, 47, 53, 11 | 0.04 Percentage | Standard Deviation 0.356 |
| FF/VI 100/25 µg PM | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Segmented Neutrophils, Day 42, n=50, 47, 53, 11 | -1.85 Percentage | Standard Deviation 10.279 |
| FF/VI 100/25 µg PM | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Segmented Neutrophils, EW, n=2, 2, 0, 0 | -0.85 Percentage | Standard Deviation 3.465 |
| FF/VI 100/25 µg PM | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Eosinophils, Day 42, n=50, 47, 53, 11 | 0.27 Percentage | Standard Deviation 2.073 |
| FF/VI 100/25 µg PM | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Eosinophils, EW, n=2, 2, 0, 0 | -0.55 Percentage | Standard Deviation 2.051 |
| FF/VI 100/25 µg PM | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Lymphocytes, Day 42, n=50, 47, 53, 11 | 1.54 Percentage | Standard Deviation 8.853 |
| FF/VI 100/25 µg PM | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Lymphocytes, EW, n=2, 2, 0, 0 | 2.00 Percentage | Standard Deviation 2.263 |
| FF/VI 100/25 µg PM | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Basophils, EW, n=2, 2, 0, 0 | 0.10 Percentage | Standard Deviation 0.141 |
| FF/VI 100/25 µg PM | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Monocytes, Day 42, n=50, 47, 53, 11 | -0.03 Percentage | Standard Deviation 3.333 |
| FF/VI 200/25 µg PM | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Eosinophils, Day 42, n=50, 47, 53, 11 | -0.99 Percentage | Standard Deviation 2.664 |
| FF/VI 200/25 µg PM | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Segmented Neutrophils, EW, n=2, 2, 0, 0 | NA Percentage | — |
| FF/VI 200/25 µg PM | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Monocytes, Day 42, n=50, 47, 53, 11 | 0.07 Percentage | Standard Deviation 2.581 |
| FF/VI 200/25 µg PM | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Lymphocytes, EW, n=2, 2, 0, 0 | NA Percentage | — |
| FF/VI 200/25 µg PM | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Basophils, EW, n=2, 2, 0, 0 | NA Percentage | — |
| FF/VI 200/25 µg PM | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Segmented Neutrophils, Day 42, n=50, 47, 53, 11 | 2.30 Percentage | Standard Deviation 9.583 |
| FF/VI 200/25 µg PM | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Eosinophils, EW, n=2, 2, 0, 0 | NA Percentage | — |
| FF/VI 200/25 µg PM | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Basophils, Day 42, n=50, 47, 53, 11 | -0.05 Percentage | Standard Deviation 0.35 |
| FF/VI 200/25 µg PM | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Monocytes, EW, n=2, 2, 0, 0 | NA Percentage | — |
| FF/VI 200/25 µg PM | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Lymphocytes, Day 42, n=50, 47, 53, 11 | -1.32 Percentage | Standard Deviation 7.844 |
| Prednisolone 10 mg AM | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Lymphocytes, Day 42, n=50, 47, 53, 11 | -2.48 Percentage | Standard Deviation 14.319 |
| Prednisolone 10 mg AM | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Basophils, Day 42, n=50, 47, 53, 11 | -0.08 Percentage | Standard Deviation 0.223 |
| Prednisolone 10 mg AM | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Basophils, EW, n=2, 2, 0, 0 | NA Percentage | — |
| Prednisolone 10 mg AM | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Eosinophils, Day 42, n=50, 47, 53, 11 | -1.11 Percentage | Standard Deviation 1.488 |
| Prednisolone 10 mg AM | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Eosinophils, EW, n=2, 2, 0, 0 | NA Percentage | — |
| Prednisolone 10 mg AM | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Segmented Neutrophils, EW, n=2, 2, 0, 0 | NA Percentage | — |
| Prednisolone 10 mg AM | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Lymphocytes, EW, n=2, 2, 0, 0 | NA Percentage | — |
| Prednisolone 10 mg AM | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Monocytes, Day 42, n=50, 47, 53, 11 | -0.70 Percentage | Standard Deviation 1.977 |
| Prednisolone 10 mg AM | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Monocytes, EW, n=2, 2, 0, 0 | NA Percentage | — |
| Prednisolone 10 mg AM | Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW) | Segmented Neutrophils, Day 42, n=50, 47, 53, 11 | 4.37 Percentage | Standard Deviation 15.667 |
Secondary
Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW
Blood samples were collected for the measurement of chloride, carbon dioxide (CO2) content/bicarbonate, glucose, potassium, sodium, and urea/blood urea nitrogen (BUN) at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.
Time frame: Baseline and Day 42/EW
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Sodium, EW, n=2, 2, 0, 0 | 1.5 Millimoles per liter (mmol/L) | Standard Deviation 3.54 |
| Placebo | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Urea/BUN, EW, n=2, 2, 0, 0 | 1.30 Millimoles per liter (mmol/L) | Standard Deviation 0.283 |
| Placebo | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Potassium, EW, n=2, 2, 0, 0 | -0.20 Millimoles per liter (mmol/L) | Standard Deviation 0.283 |
| Placebo | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Chloride, Day 42, n=55, 51, 55, 12 | 1.2 Millimoles per liter (mmol/L) | Standard Deviation 2.54 |
| Placebo | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Sodium, Day 42, n=55, 51, 55, 12 | 0.0 Millimoles per liter (mmol/L) | Standard Deviation 2.03 |
| Placebo | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | CO2 content/bicarbonate, Day 42, n=54, 50, 51, 12 | -1.0 Millimoles per liter (mmol/L) | Standard Deviation 2.86 |
| Placebo | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | CO2 content/bicarbonate, EW, n=2, 2, 0, 0 | -3.5 Millimoles per liter (mmol/L) | Standard Deviation 2.12 |
| Placebo | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Chloride, EW, n=2, 2, 0, 0 | 2.0 Millimoles per liter (mmol/L) | Standard Deviation 1.41 |
| Placebo | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Urea/BUN, Day 42, n=55, 51, 55, 12 | -0.14 Millimoles per liter (mmol/L) | Standard Deviation 1.432 |
| Placebo | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Glucose, Day 42, n=55, 51, 55, 12 | 0.11 Millimoles per liter (mmol/L) | Standard Deviation 1.117 |
| Placebo | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Glucose, EW, n=2, 2, 0, 0 | 1.00 Millimoles per liter (mmol/L) | Standard Deviation 0.283 |
| Placebo | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Potassium, Day 42, n=54, 50, 51, 12 | -0.10 Millimoles per liter (mmol/L) | Standard Deviation 0.385 |
| FF/VI 100/25 µg PM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Chloride, EW, n=2, 2, 0, 0 | -0.5 Millimoles per liter (mmol/L) | Standard Deviation 0.71 |
| FF/VI 100/25 µg PM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Potassium, Day 42, n=54, 50, 51, 12 | -0.11 Millimoles per liter (mmol/L) | Standard Deviation 0.405 |
| FF/VI 100/25 µg PM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | CO2 content/bicarbonate, EW, n=2, 2, 0, 0 | 0.0 Millimoles per liter (mmol/L) | Standard Deviation 1.41 |
| FF/VI 100/25 µg PM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Sodium, Day 42, n=55, 51, 55, 12 | -0.1 Millimoles per liter (mmol/L) | Standard Deviation 1.98 |
| FF/VI 100/25 µg PM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Sodium, EW, n=2, 2, 0, 0 | -3.5 Millimoles per liter (mmol/L) | Standard Deviation 0.71 |
| FF/VI 100/25 µg PM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Potassium, EW, n=2, 2, 0, 0 | -0.65 Millimoles per liter (mmol/L) | Standard Deviation 0.071 |
| FF/VI 100/25 µg PM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Chloride, Day 42, n=55, 51, 55, 12 | 0.9 Millimoles per liter (mmol/L) | Standard Deviation 2.76 |
| FF/VI 100/25 µg PM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Glucose, EW, n=2, 2, 0, 0 | 0.40 Millimoles per liter (mmol/L) | Standard Deviation 0.849 |
| FF/VI 100/25 µg PM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Glucose, Day 42, n=55, 51, 55, 12 | 0.23 Millimoles per liter (mmol/L) | Standard Deviation 1.037 |
| FF/VI 100/25 µg PM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | CO2 content/bicarbonate, Day 42, n=54, 50, 51, 12 | -2.0 Millimoles per liter (mmol/L) | Standard Deviation 2.98 |
| FF/VI 100/25 µg PM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Urea/BUN, EW, n=2, 2, 0, 0 | -0.85 Millimoles per liter (mmol/L) | Standard Deviation 0.919 |
| FF/VI 100/25 µg PM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Urea/BUN, Day 42, n=55, 51, 55, 12 | 0.48 Millimoles per liter (mmol/L) | Standard Deviation 1.441 |
| FF/VI 200/25 µg PM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Potassium, EW, n=2, 2, 0, 0 | NA Millimoles per liter (mmol/L) | — |
| FF/VI 200/25 µg PM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Chloride, Day 42, n=55, 51, 55, 12 | 0.7 Millimoles per liter (mmol/L) | Standard Deviation 3.06 |
| FF/VI 200/25 µg PM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Chloride, EW, n=2, 2, 0, 0 | NA Millimoles per liter (mmol/L) | — |
| FF/VI 200/25 µg PM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | CO2 content/bicarbonate, Day 42, n=54, 50, 51, 12 | -1.5 Millimoles per liter (mmol/L) | Standard Deviation 2.35 |
| FF/VI 200/25 µg PM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | CO2 content/bicarbonate, EW, n=2, 2, 0, 0 | NA Millimoles per liter (mmol/L) | — |
| FF/VI 200/25 µg PM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Glucose, Day 42, n=55, 51, 55, 12 | -0.03 Millimoles per liter (mmol/L) | Standard Deviation 0.573 |
| FF/VI 200/25 µg PM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Glucose, EW, n=2, 2, 0, 0 | NA Millimoles per liter (mmol/L) | — |
| FF/VI 200/25 µg PM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Potassium, Day 42, n=54, 50, 51, 12 | -0.16 Millimoles per liter (mmol/L) | Standard Deviation 0.379 |
| FF/VI 200/25 µg PM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Sodium, Day 42, n=55, 51, 55, 12 | -0.1 Millimoles per liter (mmol/L) | Standard Deviation 3.01 |
| FF/VI 200/25 µg PM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Sodium, EW, n=2, 2, 0, 0 | NA Millimoles per liter (mmol/L) | — |
| FF/VI 200/25 µg PM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Urea/BUN, Day 42, n=55, 51, 55, 12 | -0.00 Millimoles per liter (mmol/L) | Standard Deviation 1.236 |
| FF/VI 200/25 µg PM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Urea/BUN, EW, n=2, 2, 0, 0 | NA Millimoles per liter (mmol/L) | — |
| Prednisolone 10 mg AM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Glucose, EW, n=2, 2, 0, 0 | NA Millimoles per liter (mmol/L) | — |
| Prednisolone 10 mg AM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Glucose, Day 42, n=55, 51, 55, 12 | 0.40 Millimoles per liter (mmol/L) | Standard Deviation 1.397 |
| Prednisolone 10 mg AM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Chloride, Day 42, n=55, 51, 55, 12 | -1.0 Millimoles per liter (mmol/L) | Standard Deviation 2.41 |
| Prednisolone 10 mg AM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Sodium, EW, n=2, 2, 0, 0 | NA Millimoles per liter (mmol/L) | — |
| Prednisolone 10 mg AM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | CO2 content/bicarbonate, EW, n=2, 2, 0, 0 | NA Millimoles per liter (mmol/L) | — |
| Prednisolone 10 mg AM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | CO2 content/bicarbonate, Day 42, n=54, 50, 51, 12 | -0.1 Millimoles per liter (mmol/L) | Standard Deviation 3.12 |
| Prednisolone 10 mg AM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Urea/BUN, EW, n=2, 2, 0, 0 | NA Millimoles per liter (mmol/L) | — |
| Prednisolone 10 mg AM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Urea/BUN, Day 42, n=55, 51, 55, 12 | 0.94 Millimoles per liter (mmol/L) | Standard Deviation 1.331 |
| Prednisolone 10 mg AM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Potassium, EW, n=2, 2, 0, 0 | NA Millimoles per liter (mmol/L) | — |
| Prednisolone 10 mg AM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Potassium, Day 42, n=54, 50, 51, 12 | 0.03 Millimoles per liter (mmol/L) | Standard Deviation 0.599 |
| Prednisolone 10 mg AM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Chloride, EW, n=2, 2, 0, 0 | NA Millimoles per liter (mmol/L) | — |
| Prednisolone 10 mg AM | Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW | Sodium, Day 42, n=55, 51, 55, 12 | -0.2 Millimoles per liter (mmol/L) | Standard Deviation 1.85 |
Secondary
Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW
Blood samples were collected for the measurement of direct bilirubin, indirect bilirubin, total bilirubin, and creatinine at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.
Time frame: Baseline and Day 42/EW
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Direct Bilirubin, Day 42, n=55, 51, 55, 12 | -0.6 Micromoles per liter (µmol/L) | Standard Deviation 1.12 |
| Placebo | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Direct Bilirubin, EW, n=2, 2, 0, 0 | -1.0 Micromoles per liter (µmol/L) | Standard Deviation 0 |
| Placebo | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Indirect Bilirubin, Day 42, n=55, 51, 55, 12 | -2.0 Micromoles per liter (µmol/L) | Standard Deviation 4.89 |
| Placebo | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Indirect Bilirubin, EW, n=2, 2, 0, 0 | -1.5 Micromoles per liter (µmol/L) | Standard Deviation 2.12 |
| Placebo | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Total Bilirubin, Day 42, n=55, 51, 55, 12 | -2.5 Micromoles per liter (µmol/L) | Standard Deviation 5.66 |
| Placebo | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Total Bilirubin, EW, n=2, 2, 0, 0 | -2.5 Micromoles per liter (µmol/L) | Standard Deviation 2.12 |
| Placebo | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Creatinine, Day 42, n=55, 51, 55, 12 | -0.41 Micromoles per liter (µmol/L) | Standard Deviation 8.688 |
| Placebo | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Creatinine, EW, n=2, 2, 0, 0 | 0.00 Micromoles per liter (µmol/L) | Standard Deviation 13.435 |
| FF/VI 100/25 µg PM | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Total Bilirubin, EW, n=2, 2, 0, 0 | -2.0 Micromoles per liter (µmol/L) | Standard Deviation 0 |
| FF/VI 100/25 µg PM | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Total Bilirubin, Day 42, n=55, 51, 55, 12 | -3.2 Micromoles per liter (µmol/L) | Standard Deviation 3.72 |
| FF/VI 100/25 µg PM | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Direct Bilirubin, EW, n=2, 2, 0, 0 | 0.0 Micromoles per liter (µmol/L) | Standard Deviation 0 |
| FF/VI 100/25 µg PM | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Creatinine, EW, n=2, 2, 0, 0 | 0.95 Micromoles per liter (µmol/L) | Standard Deviation 6.435 |
| FF/VI 100/25 µg PM | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Creatinine, Day 42, n=55, 51, 55, 12 | 0.35 Micromoles per liter (µmol/L) | Standard Deviation 8.088 |
| FF/VI 100/25 µg PM | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Indirect Bilirubin, EW, n=2, 2, 0, 0 | -2.0 Micromoles per liter (µmol/L) | Standard Deviation 0 |
| FF/VI 100/25 µg PM | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Indirect Bilirubin, Day 42, n=55, 51, 55, 12 | -2.5 Micromoles per liter (µmol/L) | Standard Deviation 3.2 |
| FF/VI 100/25 µg PM | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Direct Bilirubin, Day 42, n=55, 51, 55, 12 | -0.6 Micromoles per liter (µmol/L) | Standard Deviation 1.02 |
| FF/VI 200/25 µg PM | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Creatinine, Day 42, n=55, 51, 55, 12 | 0.04 Micromoles per liter (µmol/L) | Standard Deviation 8.052 |
| FF/VI 200/25 µg PM | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Indirect Bilirubin, Day 42, n=55, 51, 55, 12 | -1.4 Micromoles per liter (µmol/L) | Standard Deviation 4.72 |
| FF/VI 200/25 µg PM | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Indirect Bilirubin, EW, n=2, 2, 0, 0 | NA Micromoles per liter (µmol/L) | — |
| FF/VI 200/25 µg PM | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Total Bilirubin, Day 42, n=55, 51, 55, 12 | -1.8 Micromoles per liter (µmol/L) | Standard Deviation 5.67 |
| FF/VI 200/25 µg PM | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Total Bilirubin, EW, n=2, 2, 0, 0 | NA Micromoles per liter (µmol/L) | — |
| FF/VI 200/25 µg PM | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Creatinine, EW, n=2, 2, 0, 0 | NA Micromoles per liter (µmol/L) | — |
| FF/VI 200/25 µg PM | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Direct Bilirubin, Day 42, n=55, 51, 55, 12 | -0.5 Micromoles per liter (µmol/L) | Standard Deviation 1.1 |
| FF/VI 200/25 µg PM | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Direct Bilirubin, EW, n=2, 2, 0, 0 | NA Micromoles per liter (µmol/L) | — |
| Prednisolone 10 mg AM | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Indirect Bilirubin, Day 42, n=55, 51, 55, 12 | -1.0 Micromoles per liter (µmol/L) | Standard Deviation 2.76 |
| Prednisolone 10 mg AM | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Indirect Bilirubin, EW, n=2, 2, 0, 0 | NA Micromoles per liter (µmol/L) | — |
| Prednisolone 10 mg AM | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Direct Bilirubin, EW, n=2, 2, 0, 0 | NA Micromoles per liter (µmol/L) | — |
| Prednisolone 10 mg AM | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Direct Bilirubin, Day 42, n=55, 51, 55, 12 | 0.3 Micromoles per liter (µmol/L) | Standard Deviation 0.75 |
| Prednisolone 10 mg AM | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Total Bilirubin, Day 42, n=55, 51, 55, 12 | -0.8 Micromoles per liter (µmol/L) | Standard Deviation 2.86 |
| Prednisolone 10 mg AM | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Creatinine, EW, n=2, 2, 0, 0 | NA Micromoles per liter (µmol/L) | — |
| Prednisolone 10 mg AM | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Creatinine, Day 42, n=55, 51, 55, 12 | 4.61 Micromoles per liter (µmol/L) | Standard Deviation 9.585 |
| Prednisolone 10 mg AM | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW | Total Bilirubin, EW, n=2, 2, 0, 0 | NA Micromoles per liter (µmol/L) | — |
Secondary
Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW
Blood samples were collected for the measurement of eosinophils, total neutrophils, platelets, and WBC count at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.
Time frame: Baseline and Day 42/EW
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | Eosinophils, Day 42, n=50, 47, 53, 11 | 0.066 10^9 cells per liter (GI/L) | Standard Deviation 0.2282 |
| Placebo | Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | Eosinophils, EW, n=2, 2, 0, 0 | 0.015 10^9 cells per liter (GI/L) | Standard Deviation 0.0071 |
| Placebo | Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | Total Neutrophils, Day 42, n=50, 47, 53, 11 | 0.017 10^9 cells per liter (GI/L) | Standard Deviation 1.3317 |
| Placebo | Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | Total Neutrophils, EW, n=2, 2, 0, 0 | -0.420 10^9 cells per liter (GI/L) | Standard Deviation 1.7253 |
| Placebo | Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | Platelets, Day 42, n=50, 48, 51, 11 | -11.1 10^9 cells per liter (GI/L) | Standard Deviation 28.72 |
| Placebo | Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | Platelets, EW, n=1, 2, 0, 0 | -2.0 10^9 cells per liter (GI/L) | — |
| Placebo | Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | WBC Day 42, n=50, 47, 53, 11 | 0.22 10^9 cells per liter (GI/L) | Standard Deviation 1.584 |
| Placebo | Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | WBC EW, n=2, 2 | -0.25 10^9 cells per liter (GI/L) | Standard Deviation 1.344 |
| FF/VI 100/25 µg PM | Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | Platelets, EW, n=1, 2, 0, 0 | -39.5 10^9 cells per liter (GI/L) | Standard Deviation 28.99 |
| FF/VI 100/25 µg PM | Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | Platelets, Day 42, n=50, 48, 51, 11 | -8.2 10^9 cells per liter (GI/L) | Standard Deviation 31.33 |
| FF/VI 100/25 µg PM | Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | Eosinophils, EW, n=2, 2, 0, 0 | -0.060 10^9 cells per liter (GI/L) | Standard Deviation 0.1697 |
| FF/VI 100/25 µg PM | Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | WBC EW, n=2, 2 | -1.65 10^9 cells per liter (GI/L) | Standard Deviation 0.778 |
| FF/VI 100/25 µg PM | Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | WBC Day 42, n=50, 47, 53, 11 | 0.71 10^9 cells per liter (GI/L) | Standard Deviation 1.787 |
| FF/VI 100/25 µg PM | Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | Total Neutrophils, EW, n=2, 2, 0, 0 | -1.165 10^9 cells per liter (GI/L) | Standard Deviation 0.997 |
| FF/VI 100/25 µg PM | Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | Total Neutrophils, Day 42, n=50, 47, 53, 11 | 0.289 10^9 cells per liter (GI/L) | Standard Deviation 1.4873 |
| FF/VI 100/25 µg PM | Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | Eosinophils, Day 42, n=50, 47, 53, 11 | 0.044 10^9 cells per liter (GI/L) | Standard Deviation 0.1608 |
| FF/VI 200/25 µg PM | Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | WBC Day 42, n=50, 47, 53, 11 | 0.96 10^9 cells per liter (GI/L) | Standard Deviation 1.367 |
| FF/VI 200/25 µg PM | Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | Total Neutrophils, Day 42, n=50, 47, 53, 11 | 0.704 10^9 cells per liter (GI/L) | Standard Deviation 1.2403 |
| FF/VI 200/25 µg PM | Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | Total Neutrophils, EW, n=2, 2, 0, 0 | NA 10^9 cells per liter (GI/L) | — |
| FF/VI 200/25 µg PM | Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | Platelets, Day 42, n=50, 48, 51, 11 | -3.9 10^9 cells per liter (GI/L) | Standard Deviation 25.31 |
| FF/VI 200/25 µg PM | Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | Platelets, EW, n=1, 2, 0, 0 | NA 10^9 cells per liter (GI/L) | — |
| FF/VI 200/25 µg PM | Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | WBC EW, n=2, 2 | NA 10^9 cells per liter (GI/L) | — |
| FF/VI 200/25 µg PM | Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | Eosinophils, Day 42, n=50, 47, 53, 11 | -0.022 10^9 cells per liter (GI/L) | Standard Deviation 0.1805 |
| FF/VI 200/25 µg PM | Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | Eosinophils, EW, n=2, 2, 0, 0 | NA 10^9 cells per liter (GI/L) | — |
| Prednisolone 10 mg AM | Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | Total Neutrophils, Day 42, n=50, 47, 53, 11 | 1.435 10^9 cells per liter (GI/L) | Standard Deviation 2.5515 |
| Prednisolone 10 mg AM | Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | Total Neutrophils, EW, n=2, 2, 0, 0 | NA 10^9 cells per liter (GI/L) | — |
| Prednisolone 10 mg AM | Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | Eosinophils, EW, n=2, 2, 0, 0 | NA 10^9 cells per liter (GI/L) | — |
| Prednisolone 10 mg AM | Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | Eosinophils, Day 42, n=50, 47, 53, 11 | -0.036 10^9 cells per liter (GI/L) | Standard Deviation 0.0803 |
| Prednisolone 10 mg AM | Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | Platelets, Day 42, n=50, 48, 51, 11 | 16.1 10^9 cells per liter (GI/L) | Standard Deviation 16.5 |
| Prednisolone 10 mg AM | Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | WBC EW, n=2, 2 | NA 10^9 cells per liter (GI/L) | — |
| Prednisolone 10 mg AM | Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | WBC Day 42, n=50, 47, 53, 11 | 1.69 10^9 cells per liter (GI/L) | Standard Deviation 2.418 |
| Prednisolone 10 mg AM | Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW | Platelets, EW, n=1, 2, 0, 0 | NA 10^9 cells per liter (GI/L) | — |
Secondary
Change From Baseline in Hematocrit Values at Day 42/EW
Blood samples were collected for the measurement of hematocrit at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.
Time frame: Baseline and Day 42/EW
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hematocrit Values at Day 42/EW | Day 42, n=50, 48, 53, 11 | -0.0123 Proportion of 1 | Standard Deviation 0.02957 |
| Placebo | Change From Baseline in Hematocrit Values at Day 42/EW | EW, n=2, 2, 0, 0 | -0.0175 Proportion of 1 | Standard Deviation 0.00071 |
| FF/VI 100/25 µg PM | Change From Baseline in Hematocrit Values at Day 42/EW | EW, n=2, 2, 0, 0 | -0.0050 Proportion of 1 | Standard Deviation 0.02263 |
| FF/VI 100/25 µg PM | Change From Baseline in Hematocrit Values at Day 42/EW | Day 42, n=50, 48, 53, 11 | -0.0120 Proportion of 1 | Standard Deviation 0.02125 |
| FF/VI 200/25 µg PM | Change From Baseline in Hematocrit Values at Day 42/EW | Day 42, n=50, 48, 53, 11 | -0.0114 Proportion of 1 | Standard Deviation 0.02151 |
| FF/VI 200/25 µg PM | Change From Baseline in Hematocrit Values at Day 42/EW | EW, n=2, 2, 0, 0 | NA Proportion of 1 | — |
| Prednisolone 10 mg AM | Change From Baseline in Hematocrit Values at Day 42/EW | Day 42, n=50, 48, 53, 11 | -0.0072 Proportion of 1 | Standard Deviation 0.02955 |
| Prednisolone 10 mg AM | Change From Baseline in Hematocrit Values at Day 42/EW | EW, n=2, 2, 0, 0 | NA Proportion of 1 | — |
Secondary
Change From Baseline in Hemoglobin Values at Day 42/EW
Blood samples were collected for the measurement of hemoglobin at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.
Time frame: Baseline and Day 42/EW
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hemoglobin Values at Day 42/EW | Day 42, n=50, 48, 53, 11 | -5.8 Grams per liter (g/L) | Standard Deviation 10.28 |
| Placebo | Change From Baseline in Hemoglobin Values at Day 42/EW | EW, n=2, 2, 0, 0 | -10.5 Grams per liter (g/L) | Standard Deviation 2.12 |
| FF/VI 100/25 µg PM | Change From Baseline in Hemoglobin Values at Day 42/EW | EW, n=2, 2, 0, 0 | -3.0 Grams per liter (g/L) | Standard Deviation 8.49 |
| FF/VI 100/25 µg PM | Change From Baseline in Hemoglobin Values at Day 42/EW | Day 42, n=50, 48, 53, 11 | -6.2 Grams per liter (g/L) | Standard Deviation 6.23 |
| FF/VI 200/25 µg PM | Change From Baseline in Hemoglobin Values at Day 42/EW | Day 42, n=50, 48, 53, 11 | -5.7 Grams per liter (g/L) | Standard Deviation 6.59 |
| FF/VI 200/25 µg PM | Change From Baseline in Hemoglobin Values at Day 42/EW | EW, n=2, 2, 0, 0 | NA Grams per liter (g/L) | — |
| Prednisolone 10 mg AM | Change From Baseline in Hemoglobin Values at Day 42/EW | Day 42, n=50, 48, 53, 11 | -3.5 Grams per liter (g/L) | Standard Deviation 9.27 |
| Prednisolone 10 mg AM | Change From Baseline in Hemoglobin Values at Day 42/EW | EW, n=2, 2, 0, 0 | NA Grams per liter (g/L) | — |
Secondary
Change From Baseline in Pulse Rate at Days 14, 28, 42, and Maximum Post-Baseline
Heart rate was measured at Baseline and at Days 14, 28, 42, and EW. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value. Scheduled, unscheduled, and early withdrawal visits were used for the maximum post-Baseline assessment.
Time frame: Days 14, 28, 42, and EW
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Pulse Rate at Days 14, 28, 42, and Maximum Post-Baseline | Day 14, n=58, 55, 56, 14 | 1.5 Beats per minute | Standard Deviation 13.05 |
| Placebo | Change From Baseline in Pulse Rate at Days 14, 28, 42, and Maximum Post-Baseline | Day 28, n=57, 55, 56, 14 | 2.9 Beats per minute | Standard Deviation 13.45 |
| Placebo | Change From Baseline in Pulse Rate at Days 14, 28, 42, and Maximum Post-Baseline | Day 42, n=55, 54, 56, 13 | -0.1 Beats per minute | Standard Deviation 12.65 |
| Placebo | Change From Baseline in Pulse Rate at Days 14, 28, 42, and Maximum Post-Baseline | Maximum post-Baseline, n=58, 56, 56, 15 | 8.0 Beats per minute | Standard Deviation 12.47 |
| FF/VI 100/25 µg PM | Change From Baseline in Pulse Rate at Days 14, 28, 42, and Maximum Post-Baseline | Day 28, n=57, 55, 56, 14 | -0.9 Beats per minute | Standard Deviation 9.32 |
| FF/VI 100/25 µg PM | Change From Baseline in Pulse Rate at Days 14, 28, 42, and Maximum Post-Baseline | Maximum post-Baseline, n=58, 56, 56, 15 | 6.0 Beats per minute | Standard Deviation 9.86 |
| FF/VI 100/25 µg PM | Change From Baseline in Pulse Rate at Days 14, 28, 42, and Maximum Post-Baseline | Day 14, n=58, 55, 56, 14 | 1.7 Beats per minute | Standard Deviation 10.7 |
| FF/VI 100/25 µg PM | Change From Baseline in Pulse Rate at Days 14, 28, 42, and Maximum Post-Baseline | Day 42, n=55, 54, 56, 13 | -0.9 Beats per minute | Standard Deviation 11.43 |
| FF/VI 200/25 µg PM | Change From Baseline in Pulse Rate at Days 14, 28, 42, and Maximum Post-Baseline | Day 42, n=55, 54, 56, 13 | 0.9 Beats per minute | Standard Deviation 8.96 |
| FF/VI 200/25 µg PM | Change From Baseline in Pulse Rate at Days 14, 28, 42, and Maximum Post-Baseline | Maximum post-Baseline, n=58, 56, 56, 15 | 5.5 Beats per minute | Standard Deviation 8.64 |
| FF/VI 200/25 µg PM | Change From Baseline in Pulse Rate at Days 14, 28, 42, and Maximum Post-Baseline | Day 14, n=58, 55, 56, 14 | 0.0 Beats per minute | Standard Deviation 8.72 |
| FF/VI 200/25 µg PM | Change From Baseline in Pulse Rate at Days 14, 28, 42, and Maximum Post-Baseline | Day 28, n=57, 55, 56, 14 | -1.9 Beats per minute | Standard Deviation 12.05 |
| Prednisolone 10 mg AM | Change From Baseline in Pulse Rate at Days 14, 28, 42, and Maximum Post-Baseline | Maximum post-Baseline, n=58, 56, 56, 15 | 2.9 Beats per minute | Standard Deviation 9.13 |
| Prednisolone 10 mg AM | Change From Baseline in Pulse Rate at Days 14, 28, 42, and Maximum Post-Baseline | Day 14, n=58, 55, 56, 14 | -1.8 Beats per minute | Standard Deviation 7.92 |
| Prednisolone 10 mg AM | Change From Baseline in Pulse Rate at Days 14, 28, 42, and Maximum Post-Baseline | Day 28, n=57, 55, 56, 14 | -2.7 Beats per minute | Standard Deviation 11.89 |
| Prednisolone 10 mg AM | Change From Baseline in Pulse Rate at Days 14, 28, 42, and Maximum Post-Baseline | Day 42, n=55, 54, 56, 13 | -2.3 Beats per minute | Standard Deviation 9.1 |
Secondary
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline
SBP and DBP were measured at Baseline and at Days 14, 28, 42, and EW. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value. Scheduled, unscheduled, and early withdrawal visits were used for the maximum post-Baseline assessment.
Time frame: Days 14, 28, 42, and EW
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | SBP, Day 14, n=58, 55, 56, 14 | -0.5 Millimeters of mercury (mmHg) | Standard Deviation 11.68 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | SBP, Day 28, n=57, 55, 56, 14 | -0.9 Millimeters of mercury (mmHg) | Standard Deviation 9.55 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | SBP, Day 42, n=55, 54, 56, 13 | 2.3 Millimeters of mercury (mmHg) | Standard Deviation 11.96 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | SBP, maximum post-Baseline, n=58, 56, 56, 15 | 6.2 Millimeters of mercury (mmHg) | Standard Deviation 11.44 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | DBP, Day 14, n=58, 55, 56, 14 | 0.0 Millimeters of mercury (mmHg) | Standard Deviation 7.92 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | DBP, Day 28, n=57, 55, 56, 14 | 1.8 Millimeters of mercury (mmHg) | Standard Deviation 8.38 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | DBP, Day 42, n=55, 54, 56, 13 | 1.2 Millimeters of mercury (mmHg) | Standard Deviation 8.77 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | DBP, maximum post-Baseline, n=58, 56, 56, 15 | -3.3 Millimeters of mercury (mmHg) | Standard Deviation 7.04 |
| FF/VI 100/25 µg PM | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | DBP, Day 28, n=57, 55, 56, 14 | -0.6 Millimeters of mercury (mmHg) | Standard Deviation 7.63 |
| FF/VI 100/25 µg PM | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | DBP, Day 14, n=58, 55, 56, 14 | -1.1 Millimeters of mercury (mmHg) | Standard Deviation 8.26 |
| FF/VI 100/25 µg PM | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | SBP, Day 28, n=57, 55, 56, 14 | -0.7 Millimeters of mercury (mmHg) | Standard Deviation 10.7 |
| FF/VI 100/25 µg PM | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | DBP, maximum post-Baseline, n=58, 56, 56, 15 | -5.2 Millimeters of mercury (mmHg) | Standard Deviation 7.76 |
| FF/VI 100/25 µg PM | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | DBP, Day 42, n=55, 54, 56, 13 | -1.2 Millimeters of mercury (mmHg) | Standard Deviation 9.13 |
| FF/VI 100/25 µg PM | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | SBP, maximum post-Baseline, n=58, 56, 56, 15 | 5.0 Millimeters of mercury (mmHg) | Standard Deviation 10.88 |
| FF/VI 100/25 µg PM | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | SBP, Day 42, n=55, 54, 56, 13 | -0.4 Millimeters of mercury (mmHg) | Standard Deviation 12.72 |
| FF/VI 100/25 µg PM | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | SBP, Day 14, n=58, 55, 56, 14 | -1.9 Millimeters of mercury (mmHg) | Standard Deviation 10.88 |
| FF/VI 200/25 µg PM | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | DBP, Day 42, n=55, 54, 56, 13 | 0.3 Millimeters of mercury (mmHg) | Standard Deviation 8.74 |
| FF/VI 200/25 µg PM | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | SBP, Day 42, n=55, 54, 56, 13 | -1.8 Millimeters of mercury (mmHg) | Standard Deviation 11.2 |
| FF/VI 200/25 µg PM | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | SBP, maximum post-Baseline, n=58, 56, 56, 15 | 3.9 Millimeters of mercury (mmHg) | Standard Deviation 10.8 |
| FF/VI 200/25 µg PM | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | DBP, Day 14, n=58, 55, 56, 14 | -0.6 Millimeters of mercury (mmHg) | Standard Deviation 9.08 |
| FF/VI 200/25 µg PM | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | DBP, Day 28, n=57, 55, 56, 14 | 0.1 Millimeters of mercury (mmHg) | Standard Deviation 9.97 |
| FF/VI 200/25 µg PM | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | DBP, maximum post-Baseline, n=58, 56, 56, 15 | -5.4 Millimeters of mercury (mmHg) | Standard Deviation 9 |
| FF/VI 200/25 µg PM | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | SBP, Day 14, n=58, 55, 56, 14 | -1.3 Millimeters of mercury (mmHg) | Standard Deviation 10.53 |
| FF/VI 200/25 µg PM | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | SBP, Day 28, n=57, 55, 56, 14 | -2.3 Millimeters of mercury (mmHg) | Standard Deviation 11.66 |
| Prednisolone 10 mg AM | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | SBP, Day 42, n=55, 54, 56, 13 | 1.5 Millimeters of mercury (mmHg) | Standard Deviation 8.26 |
| Prednisolone 10 mg AM | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | SBP, maximum post-Baseline, n=58, 56, 56, 15 | 4.9 Millimeters of mercury (mmHg) | Standard Deviation 8.61 |
| Prednisolone 10 mg AM | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | SBP, Day 28, n=57, 55, 56, 14 | -3.9 Millimeters of mercury (mmHg) | Standard Deviation 13.35 |
| Prednisolone 10 mg AM | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | SBP, Day 14, n=58, 55, 56, 14 | -1.0 Millimeters of mercury (mmHg) | Standard Deviation 13.33 |
| Prednisolone 10 mg AM | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | DBP, Day 14, n=58, 55, 56, 14 | 0.1 Millimeters of mercury (mmHg) | Standard Deviation 8.55 |
| Prednisolone 10 mg AM | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | DBP, maximum post-Baseline, n=58, 56, 56, 15 | -4.9 Millimeters of mercury (mmHg) | Standard Deviation 7.97 |
| Prednisolone 10 mg AM | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | DBP, Day 42, n=55, 54, 56, 13 | 1.2 Millimeters of mercury (mmHg) | Standard Deviation 8.69 |
| Prednisolone 10 mg AM | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline | DBP, Day 28, n=57, 55, 56, 14 | -0.4 Millimeters of mercury (mmHg) | Standard Deviation 8.11 |
Secondary
Cmax for FF on Day 42
Cmax is defined as the maximum observed concentration on Day 42. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.
Time frame: Day 42
Population: PK Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| FF/VI 100/25 µg PM | Cmax for FF on Day 42 | 19.388 picograms per milliliter (pg/mL) |
| FF/VI 200/25 µg PM | Cmax for FF on Day 42 | 33.017 picograms per milliliter (pg/mL) |
Secondary
Cmax for VI on Day 42
Cmax is defined as the maximum observed concentration on Day 42. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.
Time frame: Day 42
Population: PK Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FF/VI 100/25 µg PM | Cmax for VI on Day 42 | 101.227 picograms per milliliter (pg/mL) | Standard Deviation 73.8233 |
| FF/VI 200/25 µg PM | Cmax for VI on Day 42 | 118.531 picograms per milliliter (pg/mL) | Standard Deviation 86.8659 |
Secondary
Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.
Time frame: From the start of study medication until Day 42 (Visit 5)/Early Withdrawal
Population: Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | Any AE | 16 Participants |
| Placebo | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | Any SAE | 0 Participants |
| FF/VI 100/25 µg PM | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | Any SAE | 0 Participants |
| FF/VI 100/25 µg PM | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | Any AE | 23 Participants |
| FF/VI 200/25 µg PM | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | Any AE | 21 Participants |
| FF/VI 200/25 µg PM | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | Any SAE | 0 Participants |
| Prednisolone 10 mg AM | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | Any AE | 5 Participants |
| Prednisolone 10 mg AM | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | Any SAE | 0 Participants |
Secondary
Plasma FF and VI Pharmacokinetic (PK) Concentration
Plasma FF and VI Pharmacokinetic (PK) Concentration were estimates at the following time points:0 (immediately pre-dose inhaled study drug), and post-dose at 5 min, 15 min, 30 min, and 1 hr, 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, 24 hr on Day 42. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Pharmacokinetic Population.
Time frame: Day 42
Population: Pharmacokinetic (PK) Population: all participants in the ITT Population for whom a pharmacokinetic sample was obtained and analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FF/VI 100/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | FF, 2 hours post-dose, n=51, 53 | 15.00 picograms per milliliter (pg/mL) | Standard Deviation 9.272 |
| FF/VI 100/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | FF, 0 hour, n=53, 54 | 3.57 picograms per milliliter (pg/mL) | — |
| FF/VI 100/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | FF, 5 minutes post-dose, n=51, 54 | 16.65 picograms per milliliter (pg/mL) | Standard Deviation 10.191 |
| FF/VI 100/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | FF, 15 minutes post-dose, n=50, 54 | 16.35 picograms per milliliter (pg/mL) | Standard Deviation 10.198 |
| FF/VI 100/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | FF, 30 minutes post-dose, n=52, 52 | 17.12 picograms per milliliter (pg/mL) | Standard Deviation 10.583 |
| FF/VI 100/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | FF, 1 hour post-dose, n=54, 54 | 16.91 picograms per milliliter (pg/mL) | Standard Deviation 9.637 |
| FF/VI 100/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | FF, 4 hours post-dose, n=54, 53 | 9.78 picograms per milliliter (pg/mL) | — |
| FF/VI 100/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | FF, 9 hours post-dose, n=48, 52 | 6.20 picograms per milliliter (pg/mL) | — |
| FF/VI 100/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | FF, 12 hours post-dose, n=51, 55 | 4.62 picograms per milliliter (pg/mL) | — |
| FF/VI 100/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | FF, 16 hours post-dose, n=49, 52 | 2.55 picograms per milliliter (pg/mL) | — |
| FF/VI 100/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | FF, 20 hours post-dose, n=51, 51 | 1.74 picograms per milliliter (pg/mL) | — |
| FF/VI 100/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | FF, 24 hours post-dose, n=48, 53 | 1.55 picograms per milliliter (pg/mL) | — |
| FF/VI 100/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | VI, 0 hours, n=52, 54 | 2.57 picograms per milliliter (pg/mL) | — |
| FF/VI 100/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | VI, 5 minutes post-dose, n=50, 54 | 85.22 picograms per milliliter (pg/mL) | Standard Deviation 70.582 |
| FF/VI 100/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | VI, 2 hours post-dose, n=52, 55 | 7.09 picograms per milliliter (pg/mL) | — |
| FF/VI 100/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | VI, 4 hours post-dose, n=52, 54 | 0.00 picograms per milliliter (pg/mL) | — |
| FF/VI 100/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | VI, 9 hours post-dose, n=52, 55 | 0.00 picograms per milliliter (pg/mL) | — |
| FF/VI 100/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | VI, 12 hours post-dose, n=52, 55 | 0.00 picograms per milliliter (pg/mL) | — |
| FF/VI 100/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | VI, 16 hours post-dose, n=51, 52 | 0.00 picograms per milliliter (pg/mL) | — |
| FF/VI 100/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | VI, 20 hours post-dose, n=50, 54 | 0.00 picograms per milliliter (pg/mL) | — |
| FF/VI 100/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | VI, 24 hours post-dose, n=52, 55 | 1.19 picograms per milliliter (pg/mL) | — |
| FF/VI 100/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | VI, 15 minutes post-dose, n=48, 55 | 62.94 picograms per milliliter (pg/mL) | Standard Deviation 52.02 |
| FF/VI 100/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | VI, 30 minutes post-dose, n=51, 55 | 33.38 picograms per milliliter (pg/mL) | Standard Deviation 33.932 |
| FF/VI 100/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | VI, 1 hour post-dose, n=52, 53 | 14.63 picograms per milliliter (pg/mL) | — |
| FF/VI 200/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | VI, 5 minutes post-dose, n=50, 54 | 90.54 picograms per milliliter (pg/mL) | Standard Deviation 88.794 |
| FF/VI 200/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | FF, 20 hours post-dose, n=51, 51 | 9.28 picograms per milliliter (pg/mL) | — |
| FF/VI 200/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | VI, 0 hours, n=52, 54 | 7.95 picograms per milliliter (pg/mL) | — |
| FF/VI 200/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | FF, 0 hour, n=53, 54 | 10.02 picograms per milliliter (pg/mL) | — |
| FF/VI 200/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | VI, 16 hours post-dose, n=51, 52 | 4.76 picograms per milliliter (pg/mL) | — |
| FF/VI 200/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | FF, 5 minutes post-dose, n=51, 54 | 25.55 picograms per milliliter (pg/mL) | Standard Deviation 14.438 |
| FF/VI 200/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | VI, 1 hour post-dose, n=52, 53 | 20.07 picograms per milliliter (pg/mL) | — |
| FF/VI 200/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | FF, 15 minutes post-dose, n=50, 54 | 28.84 picograms per milliliter (pg/mL) | Standard Deviation 14.441 |
| FF/VI 200/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | VI, 30 minutes post-dose, n=51, 55 | 36.88 picograms per milliliter (pg/mL) | Standard Deviation 33.157 |
| FF/VI 200/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | FF, 30 minutes post-dose, n=52, 52 | 30.68 picograms per milliliter (pg/mL) | Standard Deviation 15.461 |
| FF/VI 200/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | VI, 2 hours post-dose, n=52, 55 | 6.06 picograms per milliliter (pg/mL) | — |
| FF/VI 200/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | FF, 1 hour post-dose, n=54, 54 | 30.07 picograms per milliliter (pg/mL) | Standard Deviation 15.54 |
| FF/VI 200/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | FF, 12 hours post-dose, n=51, 55 | 13.37 picograms per milliliter (pg/mL) | Standard Deviation 9.67 |
| FF/VI 200/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | FF, 2 hours post-dose, n=51, 53 | 30.20 picograms per milliliter (pg/mL) | Standard Deviation 18.292 |
| FF/VI 200/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | VI, 20 hours post-dose, n=50, 54 | 0.00 picograms per milliliter (pg/mL) | — |
| FF/VI 200/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | FF, 4 hours post-dose, n=54, 53 | 21.79 picograms per milliliter (pg/mL) | Standard Deviation 11.597 |
| FF/VI 200/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | VI, 4 hours post-dose, n=52, 54 | 0.45 picograms per milliliter (pg/mL) | — |
| FF/VI 200/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | FF, 9 hours post-dose, n=48, 52 | 15.99 picograms per milliliter (pg/mL) | Standard Deviation 11.667 |
| FF/VI 200/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | VI, 15 minutes post-dose, n=48, 55 | 72.53 picograms per milliliter (pg/mL) | Standard Deviation 55.271 |
| FF/VI 200/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | VI, 9 hours post-dose, n=52, 55 | 0.47 picograms per milliliter (pg/mL) | — |
| FF/VI 200/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | FF, 16 hours post-dose, n=49, 52 | 11.73 picograms per milliliter (pg/mL) | — |
| FF/VI 200/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | VI, 24 hours post-dose, n=52, 55 | 0.00 picograms per milliliter (pg/mL) | — |
| FF/VI 200/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | VI, 12 hours post-dose, n=52, 55 | 1.21 picograms per milliliter (pg/mL) | — |
| FF/VI 200/25 µg PM | Plasma FF and VI Pharmacokinetic (PK) Concentration | FF, 24 hours post-dose, n=48, 53 | 7.58 picograms per milliliter (pg/mL) | — |
Secondary
Ratio From Baseline of 0-24 Hour Urinary Free Cortisol Excretion on Day -1/1 (Baseline) and Day 42
A 24-hour urine sample was collected for the measurement of 24-hour urinary cortisol excretion at Day -1/1 (Baseline) and Day 42. Only those participants available at the specified time points were analyzed. Because values are on a logged scale, the ratio of the endpoint to Baseline is presented, as it is a measure of the difference from Baseline.
Time frame: Day -1/1 (Baseline) and Day 42
Population: Urine Cortisol (UC) Population: all participants in the ITT Population who did not have protocol deviations that were considered to affect the urine cortisol endpoint and whose urine samples were not considered to have confounding factors that would affect the interpretation of the results.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Ratio From Baseline of 0-24 Hour Urinary Free Cortisol Excretion on Day -1/1 (Baseline) and Day 42 | 0.87 ratio from Baseline | Geometric Coefficient of Variation 77.923 |
| FF/VI 100/25 µg PM | Ratio From Baseline of 0-24 Hour Urinary Free Cortisol Excretion on Day -1/1 (Baseline) and Day 42 | 1.03 ratio from Baseline | Geometric Coefficient of Variation 110.952 |
| FF/VI 200/25 µg PM | Ratio From Baseline of 0-24 Hour Urinary Free Cortisol Excretion on Day -1/1 (Baseline) and Day 42 | 0.92 ratio from Baseline | Geometric Coefficient of Variation 96.312 |
| Prednisolone 10 mg AM | Ratio From Baseline of 0-24 Hour Urinary Free Cortisol Excretion on Day -1/1 (Baseline) and Day 42 | 0.40 ratio from Baseline | Geometric Coefficient of Variation 204.433 |
Secondary
Ratio From Baseline of Serum Cortisol Trough (0-24 Hours) at Day -1/1 (Baseline) and Day 42
Serum cortisol trough is defined as the minimum value of serum cortisol measured over the 24-hour period. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr. Because values are on a logged scale, the ratio of the endpoint to Baseline is presented, as it is a measure of the difference from Baseline.
Time frame: Day -1/1 (Baseline) and Day 42
Population: SC Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Ratio From Baseline of Serum Cortisol Trough (0-24 Hours) at Day -1/1 (Baseline) and Day 42 | 1.04 ratio from Baseline | Geometric Coefficient of Variation 88.2 |
| FF/VI 100/25 µg PM | Ratio From Baseline of Serum Cortisol Trough (0-24 Hours) at Day -1/1 (Baseline) and Day 42 | 0.84 ratio from Baseline | Geometric Coefficient of Variation 88.7 |
| FF/VI 200/25 µg PM | Ratio From Baseline of Serum Cortisol Trough (0-24 Hours) at Day -1/1 (Baseline) and Day 42 | 0.73 ratio from Baseline | Geometric Coefficient of Variation 80.7 |
| Prednisolone 10 mg AM | Ratio From Baseline of Serum Cortisol Trough (0-24 Hours) at Day -1/1 (Baseline) and Day 42 | 0.28 ratio from Baseline | Geometric Coefficient of Variation 82.3 |
Secondary
Ratio From Baseline of the Serum Cortisol Area Under the Concentration-time Curve (AUC) (0-24 Hour) on Day -1/1 (Baseline) and Day 42
Area under the plasma drug concentration-time (AUC\[0-24 hour\]) curve from time zero (pre-dose) to the last time of quantifiable serum cortisol concentration at 24 hours post-dose on Day -1/1 (Baseline) and Day 42 was measured. AUC reflects the actual body exposure to drug over a specified period of time after administration of a dose. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr. Because values are on a logged scale, the ratio of the endpoint to Baseline is presented, as it is a measure of the difference from Baseline.
Time frame: Day -1/1 (Baseline) and Day 42
Population: SC Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Ratio From Baseline of the Serum Cortisol Area Under the Concentration-time Curve (AUC) (0-24 Hour) on Day -1/1 (Baseline) and Day 42 | 0.99 ratio from Baseline | Geometric Coefficient of Variation 29.6 |
| FF/VI 100/25 µg PM | Ratio From Baseline of the Serum Cortisol Area Under the Concentration-time Curve (AUC) (0-24 Hour) on Day -1/1 (Baseline) and Day 42 | 0.99 ratio from Baseline | Geometric Coefficient of Variation 40.1 |
| FF/VI 200/25 µg PM | Ratio From Baseline of the Serum Cortisol Area Under the Concentration-time Curve (AUC) (0-24 Hour) on Day -1/1 (Baseline) and Day 42 | 0.97 ratio from Baseline | Geometric Coefficient of Variation 27.2 |
| Prednisolone 10 mg AM | Ratio From Baseline of the Serum Cortisol Area Under the Concentration-time Curve (AUC) (0-24 Hour) on Day -1/1 (Baseline) and Day 42 | 0.32 ratio from Baseline | Geometric Coefficient of Variation 71.9 |
Secondary
Tmax and Tlast of FF at Day 42
tmax is defined as the time to reach the observed maximum concentration, and tlast is defined as the time of the last observed quantifiable concentration on Day 42. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.
Time frame: Day 42
Population: PK Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FF/VI 100/25 µg PM | Tmax and Tlast of FF at Day 42 | tmax | 0.500 hours |
| FF/VI 100/25 µg PM | Tmax and Tlast of FF at Day 42 | tlast | 9.000 hours |
| FF/VI 200/25 µg PM | Tmax and Tlast of FF at Day 42 | tmax | 0.500 hours |
| FF/VI 200/25 µg PM | Tmax and Tlast of FF at Day 42 | tlast | 20.042 hours |
Secondary
Tmax and Tlast of VI at Day 42
tmax is defined as the time to reach the observed maximum concentration, and tlast is defined as the time of the last observed quantifiable VI concentration on Day 42. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.
Time frame: Day 42
Population: PK Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FF/VI 100/25 µg PM | Tmax and Tlast of VI at Day 42 | tmax | 0.083 hours |
| FF/VI 100/25 µg PM | Tmax and Tlast of VI at Day 42 | tlast | 0.500 hours |
| FF/VI 200/25 µg PM | Tmax and Tlast of VI at Day 42 | tmax | 0.083 hours |
| FF/VI 200/25 µg PM | Tmax and Tlast of VI at Day 42 | tlast | 0.950 hours |