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NCT01290874 · ClinicalTrials.gov registry record · Phase 3
Blacks and Exacerbations on Long Acting Beta Agonists (LABA) vs. Tiotropium (BELT)
A Phase 3 study of Asthma, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,070
- Enrollment target
- 13
- Study locations
NCT01290874: Completed Phase 3 study of Asthma, sponsored by Brigham and Women's Hospital.
NCT01290874 is a Phase 3 study of Asthma that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 1,070 participants, below the 1,560-participant average among 374 other Asthma trials with a reported enrollment target (31% lower). The trial reports 13 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01290874, a Phase 3 study of Asthma, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,070 participants
- Enrollment target
- 13
- Study locations
Study 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.
Primary Outcome
We summarize the survival experience using mean number of exacerbations/person-year and compare it using the log-rank test comparing kaplan-meier survival curve.
Conditions Studied
Interventions
- DRUG Tiotropium
- DRUG Salmeterol
- DRUG Formoterol
Study Locations (13)
Georgia
- Urban Family Practice - Marietta
- Albany Area Primary Healthcare, Inc - Newton
New York
- UNYNET - Jefferson Family Medicine - Buffalo
- Montefiore Medical Group - The Bronx
Ohio
- Cleveland Clinic - Cleveland
- Family Medicine Occupational Health Center - Shaker Heights
Florida
- Edward Waters College Medical Center (Mayo) - Jacksonville
Illinois
- Northwestern University - Chicago
Michigan
- Wayne State University - Detroit
Mississippi
- G.A. Carmichael F.H.C. - Canton
Missouri
- Swope Parkway Health Center - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,070 participants |
| Start Date | 2011-03-30 |
| Est. Completion | 2013-07 |
| Phase | Phase 3 |
What the finished NCT01290874 record still lists
NCT01290874 is an interventional study that assigns participants to a tested intervention. Its 1,070 participants enrollment target places it among the larger protocols in the corpus, below the 1,560-participant average among 374 other Asthma trials with a reported enrollment target (31% lower).
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 3 interventions - of which Tiotropium is the first listed.
NCT01290874 lists 13 locations in 10 states (Georgia, New York, Ohio).
Frequently Asked Questions
What is clinical trial NCT01290874 about?
NCT01290874 is a clinical study titled "Blacks and Exacerbations on Long Acting Beta Agonists (LABA) vs. Tiotropium (BELT)". 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 other...
What is the current status of trial NCT01290874?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,070 participants. The study started on 2011-03-30. Estimated completion is 2013-07.
What conditions does trial NCT01290874 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT01290874?
The interventions under investigation include: Tiotropium (DRUG), Salmeterol (DRUG), Formoterol (DRUG).
Who is sponsoring clinical trial NCT01290874?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01290874 being conducted?
This trial has 13 study locations across Florida, Georgia, Illinois, Michigan, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01290874's enrollment target sits among peer trials
1,070 38th of 374 higher than 337 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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