At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 95 enrolled
Drug / intervention
Albuterol +1 moredrug
Likely dose
Albuterol 90mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-BAI (PROAIR™ HFA (Albuterol Sulfate) Breath Actuated Inhalation Aerosol) in Pediatric Asthmatics
Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Mar 30, 2006·Updated Apr 1, 2022
In Brief
A Phase 3 clinical trial evaluating Albuterol and Placebo for Asthma. Completed, enrolled 95 participants across 14 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 2006
Enrollment StartJun 2006
Primary CompletionDec 2006
TodayJul 2026
First PostedMar 30, 2006
Enrollment StartJun 10, 2006
Primary CompletionDec 4, 2006
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 20.3 years ago
Interventions
Albuteroldrug
Albuterol 90mcg
Placebodrug
Placebo