Trial Outcomes & Findings for A Study of the Bronchodilator Effect of Formoterol Fumarate Used in Combination With Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P06476 AM2) (NCT NCT01258803)
NCT ID: NCT01258803
Last Updated: 2024-05-23
Results Overview
The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.
COMPLETED
PHASE2
92 participants
Up to 12 hours postdose
2024-05-23
Participant Flow
Participants were recruited from 28 study sites in the United States. Primary Therapy Period: December 2010 to October 2011.
The study included a 4-week Run-In Period during which participants were treated with Mometasone Furoate (MF) Dry Powdered Inhaler (DPI) 100 mcg.
Participant milestones
| Measure |
Treatment Sequence 1
Treatment Period 1: Placebo Metered Dose Inhaler (MDI) with spacer, Treatment Period 2: Mometasone Furoate/Formoterol Fumarate (MF/F) MDI without spacer, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: F Dry Powder Inhaler (DPI)
|
Treatment Sequence 2
Treatment Period 1: F DPI, Treatment Period 2: MF/F MDI without spacer, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: Placebo MDI with spacer
|
Treatment Sequence 3
Treatment Period 1: MF/F MDI without spacer, Treatment Period 2: F DPI, Treatment Period 3: Placebo MDI with spacer, Treatment Period 4: MF/F MDI with spacer
|
Treatment Sequence 4
Treatment Period 1: Placebo MDI without spacer, Treatment Period 2: MF/F MDI with spacer, Treatment Period 3: F DPI, Treatment Period 4: MF/F MDI without spacer
|
Treatment Sequence 5
Treatment Period 1: MF/F MDI without spacer, Treatment Period 2: F DPI, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: Placebo MDI without spacer
|
Treatment Sequence 6
Treatment Period 1: MF/F MDI with spacer, Treatment Period 2: Placebo MDI without spacer, Treatment Period 3: MF/F MDI without spacer, Treatment Period 4: F DPI
|
|---|---|---|---|---|---|---|
|
Treatment Period 1 (1 Dose)
STARTED
|
15
|
16
|
15
|
15
|
15
|
16
|
|
Treatment Period 1 (1 Dose)
COMPLETED
|
15
|
16
|
15
|
15
|
15
|
16
|
|
Treatment Period 1 (1 Dose)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 2 (1 Dose)
STARTED
|
15
|
16
|
15
|
15
|
15
|
16
|
|
Treatment Period 2 (1 Dose)
COMPLETED
|
14
|
14
|
15
|
15
|
15
|
15
|
|
Treatment Period 2 (1 Dose)
NOT COMPLETED
|
1
|
2
|
0
|
0
|
0
|
1
|
|
Treatment Period 3 (1 Dose)
STARTED
|
14
|
14
|
15
|
15
|
15
|
15
|
|
Treatment Period 3 (1 Dose)
COMPLETED
|
14
|
14
|
14
|
15
|
15
|
15
|
|
Treatment Period 3 (1 Dose)
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Treatment Period 4 (1 Dose)
STARTED
|
14
|
14
|
14
|
15
|
15
|
15
|
|
Treatment Period 4 (1 Dose)
COMPLETED
|
14
|
14
|
14
|
15
|
15
|
15
|
|
Treatment Period 4 (1 Dose)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment Sequence 1
Treatment Period 1: Placebo Metered Dose Inhaler (MDI) with spacer, Treatment Period 2: Mometasone Furoate/Formoterol Fumarate (MF/F) MDI without spacer, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: F Dry Powder Inhaler (DPI)
|
Treatment Sequence 2
Treatment Period 1: F DPI, Treatment Period 2: MF/F MDI without spacer, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: Placebo MDI with spacer
|
Treatment Sequence 3
Treatment Period 1: MF/F MDI without spacer, Treatment Period 2: F DPI, Treatment Period 3: Placebo MDI with spacer, Treatment Period 4: MF/F MDI with spacer
|
Treatment Sequence 4
Treatment Period 1: Placebo MDI without spacer, Treatment Period 2: MF/F MDI with spacer, Treatment Period 3: F DPI, Treatment Period 4: MF/F MDI without spacer
|
Treatment Sequence 5
Treatment Period 1: MF/F MDI without spacer, Treatment Period 2: F DPI, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: Placebo MDI without spacer
|
Treatment Sequence 6
Treatment Period 1: MF/F MDI with spacer, Treatment Period 2: Placebo MDI without spacer, Treatment Period 3: MF/F MDI without spacer, Treatment Period 4: F DPI
|
|---|---|---|---|---|---|---|
|
Treatment Period 2 (1 Dose)
Protocol Violation
|
1
|
1
|
0
|
0
|
0
|
1
|
|
Treatment Period 2 (1 Dose)
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Period 3 (1 Dose)
Protocol Violation
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study of the Bronchodilator Effect of Formoterol Fumarate Used in Combination With Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P06476 AM2)
Baseline characteristics by cohort
| Measure |
All Randomized Participants
n=92 Participants
|
|---|---|
|
Age, Customized
5-7 years
|
17 participants
n=5 Participants
|
|
Age, Customized
8-11 years
|
75 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 hours postdosePopulation: Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, spacer and spirometry maneuvers; and used \>80% of prescribed MF DPI across the entire study treatment
The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.
Outcome measures
| Measure |
MF/F MDI With Spacer
n=79 Participants
Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
|
Placebo MDI With or Without Spacer
n=79 Participants
Participants receiving a single dose of Placebo MDI with or without a spacer
|
F DPI
Participants receiving a single dose of F DPI 20 mcg
|
Placebo MDI With or Without Spacer
Participants receiving a single dose of Placebo MDI with or without a spacer
|
|---|---|---|---|---|
|
Area Under the Curve From 0-12 Hours (AUC[0-12h]) of the Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) After a Single Dose of MF/F MDI With Spacer Compared to Placebo MDI Combined With or Without Spacer
|
0.115 Liters
Standard Error 0.016
|
-0.009 Liters
Standard Error 0.016
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 hours postdosePopulation: Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, spacer and spirometry maneuvers; and used \>80% of prescribed MF DPI across the entire study treatment
The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.
Outcome measures
| Measure |
MF/F MDI With Spacer
n=79 Participants
Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
|
Placebo MDI With or Without Spacer
n=79 Participants
Participants receiving a single dose of Placebo MDI with or without a spacer
|
F DPI
Participants receiving a single dose of F DPI 20 mcg
|
Placebo MDI With or Without Spacer
Participants receiving a single dose of Placebo MDI with or without a spacer
|
|---|---|---|---|---|
|
AUC(0-12h) of the Change From Baseline in FEV1 After a Single Dose MF/F MDI Without Spacer Compared to Placebo MDI Combined With or Without Spacer
|
0.093 Liters
Standard Error 0.016
|
-0.009 Liters
Standard Error 0.016
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 hours postdosePopulation: Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, spacer and spirometry maneuvers; and used \>80% of prescribed MF DPI across the entire study treatment
The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.
Outcome measures
| Measure |
MF/F MDI With Spacer
n=79 Participants
Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
|
Placebo MDI With or Without Spacer
n=79 Participants
Participants receiving a single dose of Placebo MDI with or without a spacer
|
F DPI
Participants receiving a single dose of F DPI 20 mcg
|
Placebo MDI With or Without Spacer
Participants receiving a single dose of Placebo MDI with or without a spacer
|
|---|---|---|---|---|
|
AUC(0-12h) of the Change From Baseline in FEV1 After a Single Dose of MF/F MDI With Spacer Compared to MF/F MDI Without Spacer
|
0.115 Liters
Standard Error 0.016
|
0.093 Liters
Standard Error 0.016
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 5 and 30 minutes, 1, 2, 4, 8 and 12 hours postdosePopulation: Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, spacer and spirometry maneuvers; and used \>80% of prescribed MF DPI across the entire study treatment
Baseline was defined as the average of 2 predose measurements (taken 30 minutes and immediately before dosing).
Outcome measures
| Measure |
MF/F MDI With Spacer
n=79 Participants
Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
|
Placebo MDI With or Without Spacer
n=79 Participants
Participants receiving a single dose of Placebo MDI with or without a spacer
|
F DPI
n=79 Participants
Participants receiving a single dose of F DPI 20 mcg
|
Placebo MDI With or Without Spacer
n=79 Participants
Participants receiving a single dose of Placebo MDI with or without a spacer
|
|---|---|---|---|---|
|
Change From Baseline in FEV1 After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose
Baseline (n=79, 79, 79, 79)
|
1.554 Liters
Standard Error 0.049
|
1.563 Liters
Standard Error 0.049
|
1.570 Liters
Standard Error 0.049
|
1.547 Liters
Standard Error 0.049
|
|
Change From Baseline in FEV1 After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose
5 minutes postdose (n=79, 79, 79, 79)
|
0.111 Liters
Standard Error 0.014
|
0.068 Liters
Standard Error 0.013
|
0.105 Liters
Standard Error 0.013
|
-0.001 Liters
Standard Error 0.014
|
|
Change From Baseline in FEV1 After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose
30 minutes postdose (n=79, 79, 79, 79)
|
0.131 Liters
Standard Error 0.017
|
0.099 Liters
Standard Error 0.016
|
0.117 Liters
Standard Error 0.016
|
0.006 Liters
Standard Error 0.016
|
|
Change From Baseline in FEV1 After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose
1 hour postdose (n=79, 79, 79, 79)
|
0.159 Liters
Standard Error 0.017
|
0.131 Liters
Standard Error 0.016
|
0.136 Liters
Standard Error 0.016
|
0.007 Liters
Standard Error 0.016
|
|
Change From Baseline in FEV1 After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose
2 hours postdose (n=79, 79, 79, 79)
|
0.136 Liters
Standard Error 0.018
|
0.126 Liters
Standard Error 0.018
|
0.135 Liters
Standard Error 0.018
|
0.019 Liters
Standard Error 0.018
|
|
Change From Baseline in FEV1 After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose
4 hours postdose (n=79, 79, 79, 79)
|
0.136 Liters
Standard Error 0.018
|
0.115 Liters
Standard Error 0.018
|
0.118 Liters
Standard Error 0.018
|
0.005 Liters
Standard Error 0.018
|
|
Change From Baseline in FEV1 After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose
8 hours postdose (n=79, 79, 79, 79)
|
0.108 Liters
Standard Error 0.018
|
0.093 Liters
Standard Error 0.018
|
0.087 Liters
Standard Error 0.017
|
-0.012 Liters
Standard Error 0.018
|
|
Change From Baseline in FEV1 After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose
12 hours postdose (n=78, 79, 78, 79)
|
0.092 Liters
Standard Error 0.019
|
0.046 Liters
Standard Error 0.018
|
0.059 Liters
Standard Error 0.018
|
-0.033 Liters
Standard Error 0.019
|
SECONDARY outcome
Timeframe: Up to 12 hours postdosePopulation: Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, space and spirometry maneuvers; and used \>80% of prescribed MF DPI across the entire study treatment
The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.
Outcome measures
| Measure |
MF/F MDI With Spacer
n=79 Participants
Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
|
Placebo MDI With or Without Spacer
n=79 Participants
Participants receiving a single dose of Placebo MDI with or without a spacer
|
F DPI
Participants receiving a single dose of F DPI 20 mcg
|
Placebo MDI With or Without Spacer
Participants receiving a single dose of Placebo MDI with or without a spacer
|
|---|---|---|---|---|
|
AUC (0-12h) of the Change From Baseline in FEV1 After a Single Dose of MF/F With Spacer Compared to F DPI
|
0.115 Liters
Standard Error 0.016
|
0.097 Liters
Standard Error 0.016
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 hours postdosePopulation: Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, space and spirometry maneuvers; and used \>80% of prescribed MF DPI across the entire study treatment
The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.
Outcome measures
| Measure |
MF/F MDI With Spacer
n=79 Participants
Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
|
Placebo MDI With or Without Spacer
n=79 Participants
Participants receiving a single dose of Placebo MDI with or without a spacer
|
F DPI
Participants receiving a single dose of F DPI 20 mcg
|
Placebo MDI With or Without Spacer
Participants receiving a single dose of Placebo MDI with or without a spacer
|
|---|---|---|---|---|
|
AUC (0-12h) of the Change From Baseline in FEV1 After a Single Dose of MF/F Without Spacer Compared to F DPI
|
0.093 Liters
Standard Error 0.016
|
0.097 Liters
Standard Error 0.016
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 hours postdosePopulation: Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, space and spirometry maneuvers; and used \>80% of prescribed MF DPI across the entire study treatment
The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.
Outcome measures
| Measure |
MF/F MDI With Spacer
n=79 Participants
Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
|
Placebo MDI With or Without Spacer
n=79 Participants
Participants receiving a single dose of Placebo MDI with or without a spacer
|
F DPI
Participants receiving a single dose of F DPI 20 mcg
|
Placebo MDI With or Without Spacer
Participants receiving a single dose of Placebo MDI with or without a spacer
|
|---|---|---|---|---|
|
AUC (0-12h) of the Change From Baseline in FEV1 After a Single Dose of F DPI Compared to Placebo MDI Combined With or Without Spacer
|
0.097 Liters
Standard Error 0.016
|
-0.009 Liters
Standard Error 0.016
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 5 and 30 minutes, 1, 2, 4, 8 and 12 hours postdosePopulation: Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, space and spirometry maneuvers; and used \>80% of prescribed MF DPI across the entire study treatment
Baseline was defined as the average of 2 predose FVC measurements (taken 30 minutes and immediately before dosing).
Outcome measures
| Measure |
MF/F MDI With Spacer
n=79 Participants
Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
|
Placebo MDI With or Without Spacer
n=79 Participants
Participants receiving a single dose of Placebo MDI with or without a spacer
|
F DPI
n=79 Participants
Participants receiving a single dose of F DPI 20 mcg
|
Placebo MDI With or Without Spacer
n=79 Participants
Participants receiving a single dose of Placebo MDI with or without a spacer
|
|---|---|---|---|---|
|
Change From Baseline in Forced Vital Capacity (FVC) After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose
30 minutes postdose (n=79, 79, 79, 79)
|
0.037 Liters
Standard Error 0.013
|
0.020 Liters
Standard Error 0.013
|
0.017 Liters
Standard Error 0.013
|
0.009 Liters
Standard Error 0.013
|
|
Change From Baseline in Forced Vital Capacity (FVC) After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose
1 hour postdose (n=79, 79, 79, 79)
|
0.048 Liters
Standard Error 0.015
|
0.027 Liters
Standard Error 0.014
|
0.022 Liters
Standard Error 0.014
|
-0.003 Liters
Standard Error 0.014
|
|
Change From Baseline in Forced Vital Capacity (FVC) After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose
2 hours postdose (n=79, 79, 79, 79)
|
0.023 Liters
Standard Error 0.015
|
0.026 Liters
Standard Error 0.015
|
0.047 Liters
Standard Error 0.015
|
0.015 Liters
Standard Error 0.015
|
|
Change From Baseline in Forced Vital Capacity (FVC) After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose
4 hours postdose (n=79, 79, 79, 79)
|
0.031 Liters
Standard Error 0.015
|
0.018 Liters
Standard Error 0.015
|
0.008 Liters
Standard Error 0.015
|
-0.006 Liters
Standard Error 0.015
|
|
Change From Baseline in Forced Vital Capacity (FVC) After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose
Baseline (n=79, 79, 79, 79)
|
1.914 Liters
Standard Error 0.061
|
1.931 Liters
Standard Error 0.061
|
1.928 Liters
Standard Error 0.061
|
1.913 Liters
Standard Error 0.061
|
|
Change From Baseline in Forced Vital Capacity (FVC) After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose
5 minutes postdose (n=79, 79, 79, 79)
|
0.028 Liters
Standard Error 0.012
|
0.005 Liters
Standard Error 0.012
|
0.032 Liters
Standard Error 0.012
|
0.018 Liters
Standard Error 0.012
|
|
Change From Baseline in Forced Vital Capacity (FVC) After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose
8 hours postdose (n=79, 79, 79, 79)
|
-0.001 Liters
Standard Error 0.016
|
0.007 Liters
Standard Error 0.015
|
-0.013 Liters
Standard Error 0.015
|
-0.006 Liters
Standard Error 0.015
|
|
Change From Baseline in Forced Vital Capacity (FVC) After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose
12 hours postdose (n=78, 79, 78, 79)
|
-0.001 Liters
Standard Error 0.017
|
-0.022 Liters
Standard Error 0.016
|
-0.014 Liters
Standard Error 0.016
|
-0.012 Liters
Standard Error 0.016
|
Adverse Events
MF/F MDI With Spacer
MF/F MDI Without Spacer
F DPI
Placebo MDI With or Without Spacer
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER