CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,070 enrolled
Drug / intervention
Tiotropium +2 moredrug
Likely dose
Tiotropium 18 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/NCT01290874
NCT01290874Phase 3Completed

Blacks and Exacerbations on LABA vs. Tiotropium (BELT)

Brigham and Women's Hospital·interventional·Posted Feb 7, 2011·Updated Mar 30, 2018

In Brief

A Phase 3 clinical trial evaluating Tiotropium, Salmeterol, and 1 other intervention for Asthma. Completed, enrolled 1,070 participants across 13 sites.

Detailed Summary

We are doing this study to learn how genes affect the way that people, specifically Black people, respond to treatment for asthma. Recent studies suggest that people respond differently to some asthma medications (eg Serevent, Foradil). Some people feel better when they use these inhalers, but others may not, and some people get worse. It seems that this difference shows up more often in Blacks than in Whites, which is why we are looking for Black subjects for this study. In all people, this difference seems to depend on their genes or DNA. This study is comparing the use of long acting asthma medications (Serevent, Foradil) to Tiotropium (Spiriva) for the treatment of asthma. Spiriva is used to treat chronic obstructive pulmonary disease (COPD). This study will help to see if this medication is also useful for treating asthma and whether it works better for some people than the current asthma medications.

Study Details

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

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 7, 2011
Enrollment StartMar 30, 2011
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.4 years ago

Interventions

Tiotropiumdrug

Tiotropium bromide 18 mcg once daily for one year of treatment.

Salmeteroldrug

Salmeterol 50 mcg twice daily for one year of treatment.

Formoteroldrug

Formoterol 12 mcg twice daily for one year