Asthma
Conditions
Keywords
Asthma, Pediatric asthma
Brief summary
This study is designed to evaluate the repeat-dose safety and effectiveness of a bronchodilator inhaler relative to placebo (inactive drug inhaler) in children aged 4-11 years with asthma. The dosing period lasts three weeks and starts following a three-week run-in period.
Interventions
DRUGAlbuterol
Albuterol 90mcg
DRUGPlacebo
Placebo
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Persistent asthma of a minimum of six months duration that has been stable for at least four weeks prior to screening * Male and female children aged 4-11 years, inclusive, with predicted forced expiratory volume in 1 second (FEV1) 60-90% * Ability to perform spirometry * Demonstrate 12% airways reversibility
Exclusion criteria
* Require continuous treatment with beta-blockers, monoamine oxidase inhibitors, tricyclic antidepressants, anticholinergics, and/or systemic corticosteroids * Presence of any non-asthmatic clinically-significant acute or uncontrolled chronic diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline (Predose at Day 22), 2 hours postdose at Day 22 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline-Adjusted Area Under the Percent-Predicted FEV1 Versus Time Curve Over 6 Hours (PPFEV1 AUEC0-6) at Day 22 | Predose (30 and 5 minutes) and 15, 30, 45, 60, 120, 240, and 360 minutes postdose at Day 22 | Baseline-adjusted PPFEV1 AUEC0-6 on Study Day 22 was determined using both the Day 1 and Day 22 baselines. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Albuterol-HFA-BAI Participants received albuterol | 50 |
| Placebo-HFA-BAI Participants received placebo | 45 |
| Total | 95 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 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
| Characteristic | Albuterol-HFA-BAI | Placebo-HFA-BAI | Total |
|---|---|---|---|
| Age, Continuous | 8.3 years STANDARD_DEVIATION 2.22 | 8.8 years STANDARD_DEVIATION 1.58 | 8.5 years STANDARD_DEVIATION 1.96 |
| Forced Expiratory Volume in 1 Second (FEV1) | 1.52 liters STANDARD_DEVIATION 0.44 | 1.61 liters STANDARD_DEVIATION 0.38 | 1.56 liters STANDARD_DEVIATION 0.42 |
| Race/Ethnicity, Customized Race Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Black | 13 Participants | 9 Participants | 22 Participants |
| Race/Ethnicity, Customized Race Other | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race White | 35 Participants | 36 Participants | 71 Participants |
| Sex: Female, Male Female | 27 Participants | 26 Participants | 53 Participants |
| Sex: Female, Male Male | 23 Participants | 19 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 45 |
| other Total, other adverse events | 0 / 50 | 0 / 45 |
| serious Total, serious adverse events | 0 / 50 | 0 / 45 |
Outcome results
Primary
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
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.
Time frame: Baseline (Predose at Day 22), 2 hours postdose at Day 22
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Albuterol-HFA-BAI | 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 |
| Placebo-HFA-BAI | 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 | 8.644 percent change | Standard Error 1.044 |
Comparison: Analysis was performed using an analysis of covariance (ANCOVA) with baseline FEV1 as covariate and fixed effects of pooled center and treatment group.p-value: 0.000295% CI: [2.478, 7.847]ANCOVA
Secondary
Baseline-Adjusted Area Under the Percent-Predicted FEV1 Versus Time Curve Over 6 Hours (PPFEV1 AUEC0-6) at Day 22
Baseline-adjusted PPFEV1 AUEC0-6 on Study Day 22 was determined using both the Day 1 and Day 22 baselines.
Time frame: Predose (30 and 5 minutes) and 15, 30, 45, 60, 120, 240, and 360 minutes postdose at Day 22
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albuterol-HFA-BAI | 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 |
| Albuterol-HFA-BAI | 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 |
| Placebo-HFA-BAI | 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 | 11.672 percentage of predicted FEV1*hour | Standard Error 4.476 |
| Placebo-HFA-BAI | 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 | 6.767 percentage of predicted FEV1*hour | Standard Error 6.572 |