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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:

FEV1

Exhaled 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

Page last updated: August 23, 2015

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