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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00308685
• Other study ID #: IXR-303-25-167
• Status: Completed
• Phase: Phase 3
• Start date: June 10, 2006
• Est. completion date: December 4, 2006

Study information

• Verified date: March 2022
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: December 4, 2006
• Est. primary completion date: December 4, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Albuterol
Albuterol 90mcg
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Allergy and Respiratory Center	Canton	Ohio
United States	William Storms Medical Research	Colorado Springs	Colorado
United States	Pediatric Pulmonary Associates of North Texas	Dallas	Texas
United States	Colorado Allergy and Asthma Centers, PC	Denver	Colorado
United States	Colorado Allergy and Asthma Centers, PC	Englewood	Colorado
United States	Allergy & Asthma Specialist Medical Group	Huntington Beach	California
United States	Colorado Allergy and Asthma Centers, PC	Lakewood	Colorado
United States	Little Rock Allergy and Asthma	Little Rock	Arkansas
United States	Clinical Research Institute	Minneapolis	Minnesota
United States	Sneeze, Wheeze & Itch Associates, Inc.	Normal	Illinois
United States	Allergy, Asthma & Clinical Research Center	Oklahoma City	Oklahoma
United States	The Asthma & Allergy Center, PC	Papillion	Nebraska
United States	Allergy & Asthma Associates of Santa Clara Valley Research Center	San Jose	California
United States	Southern Allergy & Asthma, PC	Savannah	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline (Predose at Day 22), 2 hours postdose at Day 22
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.	Predose (30 and 5 minutes) and 15, 30, 45, 60, 120, 240, and 360 minutes postdose at Day 22