CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 103 enrolled
Drug / intervention
Albuterol +2 moredrug
Likely dose
Albuterol 180 mcgfrom 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.

Search/NCT00577655
NCT00577655Phase 3Completed
CompareCT.gov

Phase 3 Study to Evaluate the Chronic-dose Safety and Efficacy of Albuterol-HFA-MDI Relative to Placebo in Pediatric Asthmatics

Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Dec 20, 2007·Updated Nov 12, 2021

In Brief

A Phase 3 clinical trial evaluating Albuterol, Placebo, and 1 other intervention for Asthma. Completed, enrolled 103 participants across 13 sites.

Detailed Summary

The primary objective of this study is to evaluate the chronic-dose and efficacy of Albuterol-HFA-MDI relative to placebo in pediatric asthmatics.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 20, 2007
Enrollment StartAug 1, 2007
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 18.5 years ago

Interventions

Albuteroldrug

Albuterol HFA MDI 180 mcg four times a day (q.i.d) for a total daily albuterol dose of 720 mcg for 21 days.

Placebodrug

Placebo HFA MDI four times a day (q.i.d) for 21 days.

Proventil® HFAdrug

Proventil® HFA (albuterol sulfate) Inhalation Aerosol (Key Pharmaceuticals) was used as rescue medication in this study. The rescue medication was over-labeled with instructions for emergency use in which subjects were instructed to self-administer up to two puffs every 20 minutes to a maximum of six puffs for any given episode while attempting to seek medical assistance.