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

Completed · Phase 3

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT01290874

Run by

Brigham and Women's Hospital

People needed

1070

Starts

2011-03-30

Expected to finish

2013-07-01

Last updated by the study team

2018-03-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Black (self-identified, with at least one biological parent identified as Black)
• Male and female subjects, ages 18-75
• Ability to provide informed consent
• Clinical history consistent with asthma for > 1 year.
• Ability to perform pulmonary function tests
• FEV1 > 40% of predicted
• Receiving inhaled corticosteroids (ICS)/LABA combination therapy, or ICS moderate dose monotherapy and baseline ACQ>1.25
• Non-smoker for past year (total lifetime smoking history < 10 pack-years)

You may not qualify if…

• Use of greater than the equivalent of 1000 mcg inhaled fluticasone daily
• Chronic use of oral corticosteroids or Anti IgE for asthma
• Lung disease other than asthma or diagnosis of vocal cord dysfunction.
• Significant medical illness (other than asthma) that is not stable.
• Pregnancy or lactation or an unwillingness to maintain effective birth control.
• History of a significant exacerbation of asthma or respiratory tract infection in the prior 4 weeks
• History of life-threatening asthma requiring treatment with intubation and mechanical ventilation within 5 years.
• Hypo sensitization therapy other than an established maintenance regimen.
• Use of inhaled anticholinergic therapy (ipratropium, tiotropium) in prior month
• Known contraindication to inhaled tiotropium e.g. narrow angle glaucoma, history of bladder neck obstruction or significant symptoms related to prostatic hypertrophy.
• Inability to speak and read English.

Where it is running

• Edward Waters College Medical Center (Mayo) — Jacksonville, Florida, United States
• Urban Family Practice — Marietta, Georgia, United States
• Albany Area Primary Healthcare, Inc — Newton, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Wayne State University — Detroit, Michigan, United States
• G.A. Carmichael F.H.C. — Canton, Mississippi, United States
• Swope Parkway Health Center — Kansas City, Missouri, United States
• UNYNET - Jefferson Family Medicine — Buffalo, New York, United States
• Montefiore Medical Group — The Bronx, New York, United States
• Carolinas Medical Center - NorthEast (Lovelace) — Kannapolis, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Family Medicine Occupational Health Center — Shaker Heights, Ohio, United States
• BJHCHS - Hardeeville Medical Center — Ridgeland, South Carolina, United States

Full record on ClinicalTrials.gov

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