The Effects of Different Long-acting Bronchodilator Medications on Asthma Patients With Different Genetic Variations

Stopped early · Not applicable

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT00706446

Run by

Brigham and Women's Hospital

People needed

255

Starts

2008-06-01

Expected to finish

2011-09-01

Last updated by the study team

2017-05-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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