Blacks and Exacerbations on Long Acting Beta Agonists (LABA) vs. Tiotropium (BELT)
Information source: Brigham and Women's Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Tiotropium (Drug); Salmeterol (Drug); Formoterol (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Brigham and Women's Hospital Official(s) and/or principal investigator(s): Elliot Israel, MD, Principal Investigator, Affiliation: Brigham and Women's Hospital
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.
Clinical Details
Official title: Blacks and Exacerbations on LABA vs. Tiotropium (BELT)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Rate of Exacerbations
Secondary outcome: Patient-reported outcomes (Asthma Quality of Life, Asthma Control, Asthma symptom Utility index, Symptom Free Days)Spirometry (FEV1) Rescue Medication Use Moderate Asthma Deterioration
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Black (self-identified, with at least one biological parent identified as Black)
2. Male and female subjects, ages 18-75
3. Ability to provide informed consent
4. Clinical history consistent with asthma for > 1 year.
5. Ability to perform pulmonary function tests
6. FEV1 > 40% of predicted
7. Receiving inhaled corticosteroids (ICS)/LABA combination therapy, or ICS moderate
dose monotherapy and baseline ACQ>1. 25
8. Non-smoker for past year (total lifetime smoking history < 10 pack-years)
Exclusion Criteria:
1. Use of greater than the equivalent of 1000 mcg inhaled fluticasone daily
2. Chronic use of oral corticosteroids or Anti IgE for asthma
3. Lung disease other than asthma or diagnosis of vocal cord dysfunction.
4. Significant medical illness (other than asthma) that is not stable.
5. Pregnancy or lactation or an unwillingness to maintain effective birth control.
6. History of a significant exacerbation of asthma or respiratory tract infection in the
prior 4 weeks
7. History of life-threatening asthma requiring treatment with intubation and mechanical
ventilation within 5 years.
8. Hypo sensitization therapy other than an established maintenance regimen.
9. Use of inhaled anticholinergic therapy (ipratropium, tiotropium) in prior month
10. Known contraindication to inhaled tiotropium e. g. narrow angle glaucoma, history of
bladder neck obstruction or significant symptoms related to prostatic hypertrophy.
11. Inability to speak and read English.
Locations and Contacts
Edward Waters College Medical Center (Mayo), Jacksonville, Florida 32209, United States
Urban Family Practice, Marietta, Georgia 30067, United States
Albany Area Primary Healthcare, Inc, Newton, Georgia 39870, United States
Northwestern University, Chicago, Illinois 60611, United States
Wayne State University, Detroit, Michigan 48201, United States
G.A. Carmichael F.H.C., Canton, Mississippi 39046, United States
Swope Parkway Health Center, Kansas City, Missouri 64130, United States
Montefiore Medical Group, Bronx, New York 10462, United States
UNYNET - Jefferson Family Medicine, Buffalo, New York 14215, United States
Carolinas Medical Center - NorthEast (Lovelace), Kannapolis, North Carolina 28081, United States
Cleveland Clinic, Cleveland, Ohio 44195, United States
Family Medicine Occupational Health Center, Shaker Heights, Ohio 44120, United States
BJHCHS - Hardeeville Medical Center, Ridgeland, South Carolina 29936, United States
Additional Information
Starting date: January 2011
Last updated: July 16, 2014
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