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 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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Blacks and Exacerbations on LABA vs. Tiotropium (BELT)|
- Rate of Exacerbations [ Time Frame: evaluated monthly (on average) via questionnaire for 12 months ] [ Designated as safety issue: No ]We will compare the rate of asthma exacerbations in subjects taking long acting beta agonists (LABA) versus Tiotropium over the one year treatment period.
- Patient-reported outcomes (Asthma Quality of Life, Asthma Control, Asthma symptom Utility index, Symptom Free Days) [ Time Frame: evaluated monthly (on average) via questionnaire for 12 months ] [ Designated as safety issue: No ]Patient-reported outcomes (Asthma Quality of Life, Asthma Control, Asthma symptom Utility index, Symptom Free Days)
- Spirometry (FEV1) [ Time Frame: evaluated Visits 1-4 (weeks 0, 4, 26, 52) ] [ Designated as safety issue: No ]Lung function (FEV1) will be evaluated by spirometry at each visit. (four times over the one year study period)
- Rescue Medication Use [ Time Frame: evaluated monthly (on average) via questionnaire for 12 months ] [ Designated as safety issue: No ]Monthly questionnaires will evaluate the amount of rescue medication subjects have used on average.
- Moderate Asthma Deterioration [ Time Frame: evaluated monthly (on average) via questionnaire for 12 months ] [ Designated as safety issue: No ]The definition of a moderate asthma deterioration should include one or more of the following: deterioration in symptoms, deterioration in lung function, or increased rescue bronchodilator use. These features should last for 2 days or more, but not be severe enough to warrant systemic corticosteroid use and/or hospitalization.
|Study Start Date:||January 2011|
|Study Completion Date:||July 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Tiotropium bromide will be evaluated as a treatment for asthma.
Tiotropium bromide 18 mcg once daily for one year of treatment.
Other Name: Spiriva
Active Comparator: Long Acting Beta Agonist
Long acting beta agonists (Serevent, Foradil) are the standard treatments for moderate asthma. The efficacy of Tiotropium will be compared to this standard.
Salmeterol 50 mcg twice daily for one year of treatment.
Other Name: SereventDrug: Formoterol
Formoterol 12 mcg twice daily for one year
Other Name: Foradil
Please refer to this study by its ClinicalTrials.gov identifier: NCT01290874
|United States, Florida|
|Edward Waters College Medical Center (Mayo)|
|Jacksonville, Florida, United States, 32209|
|United States, Georgia|
|Urban Family Practice|
|Marietta, Georgia, United States, 30067|
|Albany Area Primary Healthcare, Inc|
|Newton, Georgia, United States, 39870|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|United States, Michigan|
|Wayne State University|
|Detroit, Michigan, United States, 48201|
|United States, Mississippi|
|G.A. Carmichael F.H.C.|
|Canton, Mississippi, United States, 39046|
|United States, Missouri|
|Swope Parkway Health Center|
|Kansas City, Missouri, United States, 64130|
|United States, New York|
|Montefiore Medical Group|
|Bronx, New York, United States, 10462|
|UNYNET - Jefferson Family Medicine|
|Buffalo, New York, United States, 14215|
|United States, North Carolina|
|Carolinas Medical Center - NorthEast (Lovelace)|
|Kannapolis, North Carolina, United States, 28081|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Family Medicine Occupational Health Center|
|Shaker Heights, Ohio, United States, 44120|
|United States, South Carolina|
|BJHCHS - Hardeeville Medical Center|
|Ridgeland, South Carolina, United States, 29936|
|Principal Investigator:||Elliot Israel, MD||Brigham and Women's Hospital|