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

• Status: Terminated
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborators: Baim Institute for Clinical Research; Harvard Clinical Research Institute; Massachusetts General Hospital
• Treatments: Bromides; Budesonide; Fluticasone; Formoterol Fumarate; Salmeterol Xinafoate; Tiotropium Bromide; Xhance

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