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

This study has been completed.
Sponsor:
Collaborators:
Olmsted Medical Center
American Academy of Family Physicians National Research Network
Harvard Clinical Research Institute
Information provided by (Responsible Party):
Elliot Israel, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01290874
First received: December 28, 2010
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Tiotropium
Drug: Salmeterol
Drug: Formoterol
Phase 3

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 1071
Study Start Date: January 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tiotropium
Tiotropium bromide will be evaluated as a treatment for asthma.
Drug: Tiotropium
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.
Drug: Salmeterol
Salmeterol 50 mcg twice daily for one year of treatment.
Other Name: Serevent
Drug: Formoterol
Formoterol 12 mcg twice daily for one year
Other Name: Foradil

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01290874

Locations
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
Northwestern University
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 Clinic
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
Sponsors and Collaborators
Brigham and Women's Hospital
Olmsted Medical Center
American Academy of Family Physicians National Research Network
Harvard Clinical Research Institute
Investigators
Principal Investigator: Elliot Israel, MD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Elliot Israel, MD, Director of the Asthma Research Center, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01290874     History of Changes
Other Study ID Numbers: 2010p001898
Study First Received: December 28, 2010
Last Updated: July 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Brigham and Women's Hospital:
Asthma
Blacks
LABA
Tiotropium
Spiriva
African American
Serevent
salmeterol
Foradil
formoterol
Advair
Symbicort
Dulera

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Formoterol
Salmeterol
Tiotropium
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on July 24, 2014