CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Arformoterol (Brovana) +1 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/NCT00773786
NCT00773786Phase 4Completed
CompareCT.gov

A Double-Blind, Crossover Study to Assess the Effects of Nebulized Brovana Added to Tiotropium on FEV1, Hyperinflation, and Exercise Endurance Capacity in COPD

Trinity Health Of New England·interventional·Posted Oct 16, 2008·Updated Aug 6, 2019

In Brief

A Phase 4 clinical trial evaluating Arformoterol (Brovana) and Placebo for COPD. Completed, enrolled 20 participants across 1 site.

Detailed Summary

This will be a double-blind crossover trial in 20 patient with stable COPD. Data from this study will provide proof-of-concept information on whether the (anticipated) additional bronchodilator effect of Brovana added to tiotropium will lead to a meaningful improvement in the patient-centered outcome, exercise capacity. This study will only evaluate the effects of short-term (1-week) administration of Brovana. If results are positive, it would provide preliminary data for further, multicenter investigations.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD
CountriesUnited States
CollaboratorsSumitomo Pharma America, Inc.

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 16, 2008
Enrollment StartOct 1, 2008
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.7 years ago

Interventions

Arformoterol (Brovana)drug

twice daily via nebulizer added to maintenance daily tiotropium

Placebodrug

Placebo twice daily for 1 week (added to maintenance tiotropium)