Trial Outcomes & Findings for Comparison of Single-Dose Efficacy of an Albuterol Breath-Actuated Inhaler (Albuterol-HFA-BAI) Versus an Albuterol Metered-Dose Inhaler (Albuterol-HFA-MDI) in Participants With Asthma (NCT NCT00530062)
NCT ID: NCT00530062
Last Updated: 2022-09-07
Results Overview
The %FEV1 AUEC0-2 was calculated using the linear trapezoidal rule. The baseline value consisted of the average of the two predose FEV1 measurements. The mean was obtained from the mixed-effect analysis of variance adjusted for effects from the study center, the treatment sequence, and study period.
COMPLETED
PHASE4
49 participants
Baseline, Up to 2 hours postdose
2022-09-07
Participant Flow
Eligible participants were randomized to receive the following 2 treatments on separate occasions 2-7 days apart: Albuterol-hydrofluoroalkane-breath-actuated inhaler (HFA-BAI) and Albuterol-HFA-metered-dose inhaler (MDI).
Participant milestones
| Measure |
Overall Population
Participants received single actuation of albuterol 90 micrograms (mcg), administered using BAI in treatment period 1, then single actuation of albuterol 90 mcg, administered using MDI in treatment period 2. There was a washout period of 2-7 days between treatments.
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|---|---|
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Overall Study
STARTED
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49
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Overall Study
Received at Least 1 Dose of Study Drug
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49
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Overall Study
COMPLETED
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49
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Single-Dose Efficacy of an Albuterol Breath-Actuated Inhaler (Albuterol-HFA-BAI) Versus an Albuterol Metered-Dose Inhaler (Albuterol-HFA-MDI) in Participants With Asthma
Baseline characteristics by cohort
| Measure |
Overall Population
n=49 Participants
Participants received single actuation of albuterol 90 mcg, administered using BAI in treatment period 1, then single actuation of albuterol 90 mcg, administered using MDI in treatment period 2. There was a washout period of 2-7 days between treatments.
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|---|---|
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Age, Continuous
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14.1 years
STANDARD_DEVIATION 9.59 • n=5 Participants
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Sex: Female, Male
Female
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27 Participants
n=5 Participants
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Sex: Female, Male
Male
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22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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11 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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38 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race/Ethnicity, Customized
Race · Black or African heritage
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2 Participants
n=5 Participants
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Race/Ethnicity, Customized
Race · White
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47 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline, Up to 2 hours postdosePopulation: ITT population included all randomized participants who took at least 1 dose of the assigned study medication.
The %FEV1 AUEC0-2 was calculated using the linear trapezoidal rule. The baseline value consisted of the average of the two predose FEV1 measurements. The mean was obtained from the mixed-effect analysis of variance adjusted for effects from the study center, the treatment sequence, and study period.
Outcome measures
| Measure |
Albuterol-HFA-BAI
n=49 Participants
Participants received single actuation of albuterol 90 mcg, administered using BAI in treatment period 1
|
Albuterol-HFA-MDI
n=49 Participants
Participants received single actuation of albuterol 90 mcg, administered using MDI in treatment period 2.
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|---|---|---|
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Area-Under-the-Effect Curve of Percent Change in Test-Day Baseline Forced Expiratory Volume in 1 Second (FEV1) Versus Time (up to 2 Hours Postdose), %FEV1 AUEC0-2
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21.403 percent change from baseline*hour
Standard Error 2.263
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20.457 percent change from baseline*hour
Standard Error 2.253
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SECONDARY outcome
Timeframe: Baseline up to 30 minutes postdosePopulation: ITT population included all randomized participants who took at least 1 dose of the assigned study medication.
The mean was obtained from the mixed-effect analysis of variance adjusted for effects from the study center, the treatment sequence, and study period.
Outcome measures
| Measure |
Albuterol-HFA-BAI
n=49 Participants
Participants received single actuation of albuterol 90 mcg, administered using BAI in treatment period 1
|
Albuterol-HFA-MDI
n=49 Participants
Participants received single actuation of albuterol 90 mcg, administered using MDI in treatment period 2.
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|---|---|---|
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Percent Change From Baseline in FEV1 Within 30 Minutes Postdose
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10.777 percent change
Standard Error 1.185
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10.114 percent change
Standard Error 1.180
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SECONDARY outcome
Timeframe: Baseline up to 2 hours postdosePopulation: ITT population included all randomized participants who took at least 1 dose of the assigned study medication.
The mean was obtained from the mixed-effect analysis of variance adjusted for effects from the study center, the treatment sequence, and study period.
Outcome measures
| Measure |
Albuterol-HFA-BAI
n=49 Participants
Participants received single actuation of albuterol 90 mcg, administered using BAI in treatment period 1
|
Albuterol-HFA-MDI
n=49 Participants
Participants received single actuation of albuterol 90 mcg, administered using MDI in treatment period 2.
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|---|---|---|
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Percent Change From Baseline in FEV1 up to 2 Hours Postdose
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14.319 percent change
Standard Error 1.292
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13.731 percent change
Standard Error 1.286
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SECONDARY outcome
Timeframe: Baseline up to 2 hours postdosePopulation: ITT population included all randomized participants who took at least 1 dose of the assigned study medication.
The %FEV1 AUEC0-2 was calculated using the linear trapezoidal rule. The test-day baseline consisted of the average of the two predose FEV1 measurements. The mean was obtained from the mixed-effect analysis of variance adjusted for effects from the study center, the treatment sequence, and study period.
Outcome measures
| Measure |
Albuterol-HFA-BAI
n=49 Participants
Participants received single actuation of albuterol 90 mcg, administered using BAI in treatment period 1
|
Albuterol-HFA-MDI
n=49 Participants
Participants received single actuation of albuterol 90 mcg, administered using MDI in treatment period 2.
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|---|---|---|
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Area-Under-the-Effect Curve of Change in Test-Day Baseline FEV1 Versus Time (up to 2 Hours Postdose), FEV1 AUEC0-2
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0.443 liters*hours
Standard Error 0.044
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0.407 liters*hours
Standard Error 0.044
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SECONDARY outcome
Timeframe: Baseline up to 2 hours postdosePopulation: ITT population included all randomized participants who took at least 1 dose of the assigned study medication.
Outcome measures
| Measure |
Albuterol-HFA-BAI
n=49 Participants
Participants received single actuation of albuterol 90 mcg, administered using BAI in treatment period 1
|
Albuterol-HFA-MDI
n=49 Participants
Participants received single actuation of albuterol 90 mcg, administered using MDI in treatment period 2.
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|---|---|---|
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Percentage of Participants With a 12% Increase From Baseline in FEV1 Within 2 Hours Postdose
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57.1 percentage of participants
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42.9 percentage of participants
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SECONDARY outcome
Timeframe: Baseline up to 2 hours postdosePopulation: ITT population included all randomized participants who took at least 1 dose of the assigned study medication.
Outcome measures
| Measure |
Albuterol-HFA-BAI
n=49 Participants
Participants received single actuation of albuterol 90 mcg, administered using BAI in treatment period 1
|
Albuterol-HFA-MDI
n=49 Participants
Participants received single actuation of albuterol 90 mcg, administered using MDI in treatment period 2.
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|---|---|---|
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Percentage of Participants With a 15% Increase From Baseline in FEV1 Within 2 Hours Postdose
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32.7 percentage of participants
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30.6 percentage of participants
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SECONDARY outcome
Timeframe: Baseline up to 2 hours postdosePopulation: ITT population included all randomized participants who took at least 1 dose of the assigned study medication.
The number of minutes required for the baseline FEV1 to increase by at least 12% within the 2-hour observation period. Median time and corresponding confidence intervals (CIs) were obtained via the Kaplan-Meier estimate.
Outcome measures
| Measure |
Albuterol-HFA-BAI
n=49 Participants
Participants received single actuation of albuterol 90 mcg, administered using BAI in treatment period 1
|
Albuterol-HFA-MDI
n=49 Participants
Participants received single actuation of albuterol 90 mcg, administered using MDI in treatment period 2.
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|---|---|---|
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Time to a 12% Increase From Baseline in FEV1 Within 2 Hours Postdose
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60.00 minutes
Interval 45.0 to
Due to smaller number of participants with an event, upper limit of 95% CI was not estimable.
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NA minutes
Interval 46.0 to
Due to smaller number of participants with an event, median and upper limit of 95% CI was not estimable.
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SECONDARY outcome
Timeframe: Baseline up to 2 hours postdosePopulation: ITT population included all randomized participants who took at least 1 dose of the assigned study medication.
The number of minutes required for the baseline FEV1 to increase by at least 15% within the 2-hour observation period. Median time and corresponding CIs were obtained via the Kaplan-Meier estimate.
Outcome measures
| Measure |
Albuterol-HFA-BAI
n=49 Participants
Participants received single actuation of albuterol 90 mcg, administered using BAI in treatment period 1
|
Albuterol-HFA-MDI
n=49 Participants
Participants received single actuation of albuterol 90 mcg, administered using MDI in treatment period 2.
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|---|---|---|
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Time to a 15% Increase From Baseline in FEV1 Within 2 Hours Postdose
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NA minutes
Interval 123.0 to
Due to smaller number of participants with an event, median and upper limit of 95% CI was not estimable.
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NA minutes
Not enough participants experienced a 15% increase in FEV1 and therefore the median could not be calculated.
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SECONDARY outcome
Timeframe: Baseline up to 2 hours postdosePopulation: ITT population included all randomized participants who took at least 1 dose of the assigned study medication.
Each calculation for FEV1 took several minutes in order to obtain the highest of 3 measurements. The total collection time exceeded the 120 mins post-dose time frame for some participants.
Outcome measures
| Measure |
Albuterol-HFA-BAI
n=49 Participants
Participants received single actuation of albuterol 90 mcg, administered using BAI in treatment period 1
|
Albuterol-HFA-MDI
n=49 Participants
Participants received single actuation of albuterol 90 mcg, administered using MDI in treatment period 2.
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|---|---|---|
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Time to Maximum Increase in FEV1
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48.00 minutes
Interval 15.0 to 123.0
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45.00 minutes
Interval 11.0 to 128.0
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Adverse Events
Albuterol-HFA-BAI
Albuterol-HFA-MDI
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