Trial Outcomes & Findings for Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-BAI in Pediatric Asthmatics (NCT NCT00308685)
NCT ID: NCT00308685
Last Updated: 2022-04-01
Results Overview
The baseline FEV1 was defined as the average of the two predose measurements ( at -0.5 and 0.0 hour) on the test day (Day 22). The mean was obtained from the analysis of covariance (ANCOVA) adjusted for baseline FEV1 and the pooled investigational center.
COMPLETED
PHASE3
95 participants
Baseline (Predose at Day 22), 2 hours postdose at Day 22
2022-04-01
Participant Flow
Participant milestones
| Measure |
Albuterol-HFA-BAI
Participants received albuterol
|
Placebo-HFA-BAI
Participants received placebo
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
45
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
50
|
45
|
|
Overall Study
COMPLETED
|
47
|
40
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
Albuterol-HFA-BAI
Participants received albuterol
|
Placebo-HFA-BAI
Participants received placebo
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Need to administer prohibited medication
|
1
|
2
|
|
Overall Study
Other than specified
|
1
|
3
|
Baseline Characteristics
Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-BAI in Pediatric Asthmatics
Baseline characteristics by cohort
| Measure |
Albuterol-HFA-BAI
n=50 Participants
Participants received albuterol
|
Placebo-HFA-BAI
n=45 Participants
Participants received placebo
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.3 years
STANDARD_DEVIATION 2.22 • n=5 Participants
|
8.8 years
STANDARD_DEVIATION 1.58 • n=7 Participants
|
8.5 years
STANDARD_DEVIATION 1.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Forced Expiratory Volume in 1 Second (FEV1)
|
1.52 liters
STANDARD_DEVIATION 0.44 • n=5 Participants
|
1.61 liters
STANDARD_DEVIATION 0.38 • n=7 Participants
|
1.56 liters
STANDARD_DEVIATION 0.42 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Predose at Day 22), 2 hours postdose at Day 22Population: Intent-to-treat (ITT) population included all randomized participants who took at least 1 dose of the assigned study medication and had at least 1 postdose spirometry measurement.
The baseline FEV1 was defined as the average of the two predose measurements ( at -0.5 and 0.0 hour) on the test day (Day 22). The mean was obtained from the analysis of covariance (ANCOVA) adjusted for baseline FEV1 and the pooled investigational center.
Outcome measures
| Measure |
Albuterol-HFA-BAI
n=50 Participants
Participants received albuterol
|
Placebo-HFA-BAI
n=45 Participants
Participants received placebo
|
|---|---|---|
|
Maximum Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Observed up to 2 Hours Following Completion of Dosing (FEV1max%0-2) at Day 22
|
13.807 percent change
Standard Error 0.954
|
8.644 percent change
Standard Error 1.044
|
SECONDARY outcome
Timeframe: Predose (30 and 5 minutes) and 15, 30, 45, 60, 120, 240, and 360 minutes postdose at Day 22Population: ITT population included all randomized participants who took at least 1 dose of the assigned study medication and had at least 1 postdose spirometry measurement.
Baseline-adjusted PPFEV1 AUEC0-6 on Study Day 22 was determined using both the Day 1 and Day 22 baselines.
Outcome measures
| Measure |
Albuterol-HFA-BAI
n=50 Participants
Participants received albuterol
|
Placebo-HFA-BAI
n=45 Participants
Participants received placebo
|
|---|---|---|
|
Baseline-Adjusted Area Under the Percent-Predicted FEV1 Versus Time Curve Over 6 Hours (PPFEV1 AUEC0-6) at Day 22
PPFEV1 AUEC0-6 on Day 22 Using Day 22 Baseline
|
29.473 percentage of predicted FEV1*hour
Standard Error 4.033
|
11.672 percentage of predicted FEV1*hour
Standard Error 4.476
|
|
Baseline-Adjusted Area Under the Percent-Predicted FEV1 Versus Time Curve Over 6 Hours (PPFEV1 AUEC0-6) at Day 22
PPFEV1 AUEC0-6 on Day 22 Using Day 1 Baseline
|
43.182 percentage of predicted FEV1*hour
Standard Error 6.036
|
6.767 percentage of predicted FEV1*hour
Standard Error 6.572
|
Adverse Events
Albuterol-HFA-BAI
Placebo-HFA-BAI
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products R&D, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
- Publication restrictions are in place
Restriction type: OTHER