Study of the Effects of Different Long-acting Bronchodilator Medications on Asthma Patients With Different Genetic Variations
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 bromide (Drug); salmeterol or formoterol (Drug)
Phase: N/A
Status: Terminated
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
This study is looking at the effects of certain long-acting bronchodilators on patients with
asthma who have specific genetic variations. The investigators are interested in a certain
common genetic variation in the receptor for beta-agonists, which is found in as many of
one-sixth of the population. There is evidence that patients with asthma who have this
variation may not do as well when treated with albuterol on a regular basis. The
investigators will be looking at whether patients with this variation have more asthma
exacerbations over the course of a year when treated with salmeterol or formoterol, which
are long-acting forms of albuterol; and whether these patients have fewer exacerbations when
treated with tiotropium, which is a different long-acting bronchodilator that does not act
at this receptor. In both groups patients will also be receiving inhaled steroids.
Clinical Details
Official title: Genotype Stratified Treatment With Anticholinergic vs. Beta-agonist (Long Acting) and Exacerbations (GABLE)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Asthma exacerbations
Secondary outcome: FEV1Exhaled NO Symptom-free days Asthma-related Quality of Life
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Clinical history consistent with asthma
- Has a current prescription for a long-acting beta agonist, either along or in
combination with an inhaled corticosteroid (salmeterol, formoterol,
fluticasone/salmeterol, or budesonide/formoterol)
- Ability to provide informed consent
- Non-smoker (total lifetime smoking history < 10 pack-years; no more than five
occasions of smoking any substance or using smokeless tobacco products in the past
year)
- No smoking or use of smokeless tobacco in the past 30 days
- No known contraindication to inhaled tiotropium e. g. narrow angle glaucoma, history
of bladder neck obstruction or significant symptoms related to prostatic hypertrophy
Exclusion Criteria:
- Lung disease other than asthma
- Established or suspected diagnosis of vocal cord dysfunction
- Significant medical illness (other than asthma) that is not stable
- History of life-threatening asthma requiring treatment with intubation and mechanical
ventilation within the past 5 years
- History of respiratory tract infection within the previous 4 weeks (only applies at
screening visits)
- Hyposensitization therapy other than an established maintenance regimen
- Allergy to tiotropium
- Pregnancy or lactation. If potentially able to bear children, not using an acceptable
form of birth control
- Inability to use inhaler devices
- Inability to participate over the one year period
- Current use of tiotropium
Locations and Contacts
Brigham and Women's Hospital, Boston, Massachusetts 02115, United States
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information
Brigham and Women's Hospital Asthma Research Center
Starting date: June 2008
Last updated: July 16, 2014
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