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

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.

Timeline

Start

2006-06-10

Primary completion

2006-12-04

Completion

2006-12-04

Outcome

Met primary endpoint

registry Albuterol-HFA-BAI vs Placebo-HFA-BAI; p = 0.0002 NCT00308685 ↗

registry Difference in adjusted means 5.163 (95% CI 2.478 to 7.847) NCT00308685 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Salbutamol	Unknown	90 ug	Inhaled

Indications