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

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: Placebo; Drug: Albuterol

• Registration Number: NCT00308685
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-03-28
• Study First Submitted QC: 2006-03-28
• Study First Posted: 2006-03-30
• Study Start: 2006-06-10
• Primary Completion: 2006-12-04
• Study Completion: 2006-12-04
• Disposition First Submitted: 2013-08-27
• Disposition First Submitted QC: 2013-08-27
• Disposition First Posted: 2013-09-12
• Results First Submitted: 2022-01-31
• Results First Submitted QC: 2022-01-31
• Results First Posted: 2022-02-24
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-22
• Last Update Posted: 2022-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo-HFA-BAI	Placebo	Placebo
Albuterol-HFA-BAI	Albuterol	ProAir(TM) HFA, Breath Actuated Inhalation Aerosol

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (12)

Allergy & Asthma Specialist Medical Group; 🇺🇸 Huntington Beach, California, United States

Little Rock Allergy and Asthma; 🇺🇸 Little Rock, Arkansas, United States

Allergy & Asthma Associates of Santa Clara Valley Research Center; 🇺🇸 San Jose, California, United States

William Storms Medical Research; 🇺🇸 Colorado Springs, Colorado, United States

Colorado Allergy and Asthma Centers, PC; 🇺🇸 Lakewood, Colorado, United States

Sneeze, Wheeze & Itch Associates, Inc.; 🇺🇸 Normal, Illinois, United States

Clinical Research Institute; 🇺🇸 Minneapolis, Minnesota, United States

Allergy, Asthma & Clinical Research Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Pediatric Pulmonary Associates of North Texas; 🇺🇸 Dallas, Texas, United States

Southern Allergy & Asthma, PC; 🇺🇸 Savannah, Georgia, United States

Allergy and Respiratory Center; 🇺🇸 Canton, Ohio, United States

The Asthma & Allergy Center, PC; 🇺🇸 Papillion, Nebraska, United States