Blacks and Exacerbations on Long Acting Beta Agonists (LABA) vs. Tiotropium (BELT)
BELT
Blacks and Exacerbations on LABA vs. Tiotropium (BELT)
1 other identifier
interventional
1,070
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 asthma
Started Mar 2011
Typical duration for phase_3 asthma
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 28, 2010
CompletedFirst Posted
Study publicly available on registry
February 7, 2011
CompletedStudy Start
First participant enrolled
March 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedResults Posted
Study results publicly available
March 30, 2018
CompletedMarch 30, 2018
March 1, 2018
2.3 years
December 28, 2010
March 6, 2017
March 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Asthma Exacerbation (Mean Number of Exacerbations/Person-year)
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.
evaluated monthly (on average) via questionnaire for 12 months
Secondary Outcomes (7)
Change in FEV1
from baseline to 12 months
Change in Asthma Control Questionnaire (ACQ)
from baseline to 12 months
Change in Asthma Quality of Life (AQLQ)
from baseline to 12 months
Change in Asthma Symptom Utility Index (ASUI)
from baseline to 12 months
Change in Symptom-Free Day Questionnaire (SFDQ)
from baseline to 12 months
- +2 more secondary outcomes
Study Arms (2)
Tiotropium
EXPERIMENTALTiotropium bromide will be evaluated as a treatment for asthma.
Salmeterol or Formoterol
ACTIVE COMPARATORLong acting beta agonists (Serevent, Foradil) are the standard treatments for moderate asthma. The efficacy of Tiotropium will be compared to this standard.
Interventions
Tiotropium bromide 18 mcg once daily for one year of treatment.
Salmeterol 50 mcg twice daily for one year of treatment.
Formoterol 12 mcg twice daily for one year
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brigham and Women's Hospitallead
- Olmsted Medical Centercollaborator
- American Academy of Family Physicians National Research Networkcollaborator
- Baim Institute for Clinical Researchcollaborator
Study Sites (13)
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
UNYNET - Jefferson Family Medicine
Buffalo, New York, 14215, United States
Montefiore Medical Group
The Bronx, New York, 10462, 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
Related Publications (2)
Wechsler ME, Yawn BP, Fuhlbrigge AL, Pace WD, Pencina MJ, Doros G, Kazani S, Raby BA, Lanzillotti J, Madison S, Israel E; BELT Investigators. Anticholinergic vs Long-Acting beta-Agonist in Combination With Inhaled Corticosteroids in Black Adults With Asthma: The BELT Randomized Clinical Trial. JAMA. 2015 Oct 27;314(16):1720-30. doi: 10.1001/jama.2015.13277.
PMID: 26505596RESULTOba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
PMID: 36472162DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Elliot Israel
- Organization
- Brigham and Women's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Elliot Israel, MD
Brigham and Women's Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Asthma Research Center
Study Record Dates
First Submitted
December 28, 2010
First Posted
February 7, 2011
Study Start
March 30, 2011
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
March 30, 2018
Results First Posted
March 30, 2018
Record last verified: 2018-03