CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 53 enrolled
Drug / intervention
arformoterol +1 moredrug
Likely dose
levalbuterol 0.63 mgfrom 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/NCT00583947
NCT00583947Phase 2Completed
CompareCT.gov

A Cumulative Dose Safety and Tolerability Crossover Study of Arformoterol Tartrate Inhalation Solution and Levalbuterol Hydrochloride Inhalation Solution in Pediatric Subjects (Aged 2 to 11 Years of Age) With Asthma

Sumitomo Pharma America, Inc.·interventional·Posted Jan 2, 2008·Updated Feb 22, 2012

In Brief

A Phase 2 clinical trial evaluating arformoterol and levalbuterol for Asthma. Completed, enrolled 53 participants across 14 sites.

Detailed Summary

To determine the safety and tolerability of Arformoterol Tartrate in children with asthma

Study Details

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

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 2, 2008
Enrollment StartJan 1, 2008
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 18.5 years ago

Interventions

arformoteroldrug

Arformoterol is given at a 7.5 ug per dosing during the cross-over phase and 15 ug per dosing during the open-label phase. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).

levalbuteroldrug

Levalbuterol is given at a 0.63 mg per dosing during the cross-over phase. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).