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

• Patient-reported outcomes (Asthma Quality of Life, Asthma Control, Asthma symptom Utility index, Symptom Free Days) [ Time Frame: evaluated monthly (on average) via questionnaire for 12 months ] [ Designated as safety issue: No ]
  Patient-reported outcomes (Asthma Quality of Life, Asthma Control, Asthma symptom Utility index, Symptom Free Days)
• Spirometry (FEV1) [ Time Frame: evaluated Visits 1-4 (weeks 0, 4, 26, 52) ] [ Designated as safety issue: No ]
  Lung function (FEV1) will be evaluated by spirometry at each visit. (four times over the one year study period)
• Rescue Medication Use [ Time Frame: evaluated monthly (on average) via questionnaire for 12 months ] [ Designated as safety issue: No ]
  Monthly questionnaires will evaluate the amount of rescue medication subjects have used on average.
• Moderate Asthma Deterioration [ Time Frame: evaluated monthly (on average) via questionnaire for 12 months ] [ Designated as safety issue: No ]
  The definition of a moderate asthma deterioration should include one or more of the following: deterioration in symptoms, deterioration in lung function, or increased rescue bronchodilator use. These features should last for 2 days or more, but not be severe enough to warrant systemic corticosteroid use and/or hospitalization.

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.

• Drug: Tiotropium
  Tiotropium bromide 18 mcg once daily for one year of treatment.
  Other Name: Spiriva
• Drug: Salmeterol
  Salmeterol 50 mcg twice daily for one year of treatment.
  Other Name: Serevent
• Drug: Formoterol
  Formoterol 12 mcg twice daily for one year
  Other Name: Foradil

• Experimental: Tiotropium
  Tiotropium bromide will be evaluated as a treatment for asthma.
  Intervention: Drug: Tiotropium
• Active Comparator: Long Acting Beta Agonist
  Long acting beta agonists (Serevent, Foradil) are the standard treatments for moderate asthma. The efficacy of Tiotropium will be compared to this standard.
  Interventions:

  • Drug: Salmeterol
  • Drug: Formoterol

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.

• Olmsted Medical Center
• American Academy of Family Physicians National Research Network
• Harvard Clinical Research Institute