Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-BAI in Pediatric Asthmatics

Study Overview
=================
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.

Official Title
-----------------
Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-BAI (PROAIR™ HFA (Albuterol Sulfate) Breath Actuated Inhalation Aerosol) in Pediatric Asthmatics

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Albuterol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 11 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Albuterol-HFA-BAI<br>ProAir(TM) HFA, Breath Actuated Inhalation Aerosol | Drug: Albuterol<br>* Albuterol 90mcg<br>|
| Placebo Comparator: Placebo-HFA-BAI<br>Placebo | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline (Predose at Day 22), 2 hours postdose at Day 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Predose (30 and 5 minutes) and 15, 30, 45, 60, 120, 240, and 360 minutes postdose at Day 22 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Pediatric asthma