CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 197 enrolled
Drug / intervention
Levalbuterol +2 moredrug
Likely dose
Not stated in 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/NCT00809757
NCT00809757Phase 3Completed
CompareCT.gov

A Safety, Efficacy, and Tolerability Study of Daily Dosing With Levalbuterol Tartrate HFA MDI and Placebo in Subjects Aged Birth to <48 Months With Asthma

Sumitomo Pharma America, Inc.·interventional·Posted Dec 17, 2008·Updated Jul 28, 2014

In Brief

A Phase 3 clinical trial evaluating Levalbuterol, Levalbuterol UDV TID, and 1 other intervention for Asthma. Completed, enrolled 197 participants across 46 sites.

Detailed Summary

A Safety, Efficacy, and Tolerability Study of Daily Dosing with Levalbuterol Tartrate HFA MDI and Placebo in Subjects Aged Birth to \<48 Months with Asthma.

Study Details

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

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 17, 2008
Enrollment StartDec 1, 2008
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 17.5 years ago

Interventions

Levalbuteroldrug

90 ug Levalbuterol (2 actuations)

Levalbuterol UDV TIDdrug

0.31 ug Levalbuterol UDV TID

Placebodrug

Placebo (2 actuations)