Blacks and Exacerbations on Long Acting Beta Agonists (LABA) vs. Tiotropium (BELT)

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

We are doing this study to learn how genes affect the way that people, specifically Black people, respond to treatment for asthma. Recent studies suggest that people respond differently to some asthma medications (eg Serevent, Foradil). Some people feel better when they use these inhalers, but others may not, and some people get worse. It seems that this difference shows up more often in Blacks than in Whites, which is why we are looking for Black subjects for this study. In all people, this difference seems to depend on their genes or DNA. This study is comparing the use of long acting asthma medications (Serevent, Foradil) to Tiotropium (Spiriva) for the treatment of asthma. Spiriva is used to treat chronic obstructive pulmonary disease (COPD). This study will help to see if this medication is also useful for treating asthma and whether it works better for some people than the current asthma medications.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborators: American Academy of Family Physicians National Research Network; Baim Institute for Clinical Research; Harvard Clinical Research Institute; Olmsted Medical Center
• Treatments: Formoterol Fumarate; Salmeterol Xinafoate; Tiotropium Bromide

Criteria

Inclusion Criteria:

1. Black (self-identified, with at least one biological parent identified as Black)

2. Male and female subjects, ages 18-75

3. Ability to provide informed consent

4. Clinical history consistent with asthma for > 1 year.

5. Ability to perform pulmonary function tests

6. FEV1 > 40% of predicted

7. Receiving inhaled corticosteroids (ICS)/LABA combination therapy, or ICS moderate dose monotherapy and baseline ACQ>1.25

8. Non-smoker for past year (total lifetime smoking history < 10 pack-years)

Exclusion Criteria:

1. Use of greater than the equivalent of 1000 mcg inhaled fluticasone daily

2. Chronic use of oral corticosteroids or Anti IgE for asthma

3. Lung disease other than asthma or diagnosis of vocal cord dysfunction.

4. Significant medical illness (other than asthma) that is not stable.

5. Pregnancy or lactation or an unwillingness to maintain effective birth control.

6. History of a significant exacerbation of asthma or respiratory tract infection in the prior 4 weeks

7. History of life-threatening asthma requiring treatment with intubation and mechanical ventilation within 5 years.

8. Hypo sensitization therapy other than an established maintenance regimen.

9. Use of inhaled anticholinergic therapy (ipratropium, tiotropium) in prior month

10. Known contraindication to inhaled tiotropium e.g. narrow angle glaucoma, history of bladder neck obstruction or significant symptoms related to prostatic hypertrophy.

11. Inability to speak and read English.