Status:
TERMINATED
The Effects of Different Long-acting Bronchodilator Medications on Asthma Patients With Different Genetic Variations
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Baim Institute for Clinical Research
Massachusetts General Hospital
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 v...
Detailed Description
Asthma affects 7% of the population in the United States. Asthma morbidity and mortality has increased over the past decade. Long-acting β-agonists (LABAs) combined with inhaled corticosteroids are th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT00706446
Start Date
June 1 2008
End Date
September 1 2011
Last Update
May 31 2017
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115