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Blacks and Exacerbations on Long Acting Beta Agonists (LABA) vs. Tiotropium (BELT)

NCT01290874 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1070

Last updated 2018-03-30

Study results available
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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.

Conditions

Interventions

DRUG

Tiotropium

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

DRUG

Salmeterol

Salmeterol 50 mcg twice daily for one year of treatment.

DRUG

Formoterol

Formoterol 12 mcg twice daily for one year

Sponsors & Collaborators

  • Olmsted Medical Center

    collaborator OTHER

  • American Academy of Family Physicians National Research Network

    collaborator NETWORK

  • Baim Institute for Clinical Research

    collaborator OTHER

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Elliot Israel, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-30
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01290874 on ClinicalTrials.gov