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

Teva Branded Pharmaceutical Products R&D, Inc.95 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Asthma

Interventions

AlbuterolDRUG

Albuterol 90mcg

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 4 YearsMax age: 11 Years

Medical Language ↔ Plain English

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

Locations (14)

Little Rock Allergy and Asthma

Little Rock, Arkansas, United States

Allergy & Asthma Specialist Medical Group

Huntington Beach, California, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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