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

Condition(s) targeted: Asthma

Intervention: tiotropium bromide (Drug); salmeterol or formoterol (Drug)

Phase: N/A

Status: Recruiting

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

Overall contact:
Stefanie Dutile, Phone: 617-732-8266

This study is looking at the effects of certain long-acting bronchodilators on patients with asthma who have specific genetic variations. We 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. We 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.

Official title: Genotype Stratified Treatment With Anticholinergic vs. Beta-agonist (Long Acting) and Exacerbations (GABLE)

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Asthma exacerbations

Secondary outcome:

FEV1

Exhaled NO

Symptom-free days

Asthma-related Quality of Life

Minimum age: 18 Years. Maximum age: 70 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.

Stefanie Dutile, Phone: 617-732-8266

Brigham and Women's Hospital, Boston, Massachusetts 02115, United States; Recruiting
Elliot Israel, MD, Principal Investigator

Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Fiona Gibbons, MD, Principal Investigator

Brigham and Women's Hospital Asthma Research Center

Starting date: June 2008
Ending date: December 2010
Last updated: September 15, 2009