Blacks and Exacerbations on Long Acting Beta Agonists (LABA) vs. Tiotropium (BELT)
Condition: Asthma
MeSH terms: Asthma
Intervention: Tiotropium; Salmeterol; Formoterol
Intervention description: Tiotropium bromide 18 mcg once daily for one year of treatment.; Salmeterol 50 mcg twice daily for one year of treatment.; Formoterol 12 mcg twice daily for one year
Intervention MeSH terms: Formoterol Fumarate; Tiotropium Bromide; Salmeterol Xinafoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1070.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Asthma; Blacks; LABA; Tiotropium; Spiriva; African American; Serevent; salmeterol; Foradil; formoterol; Advair; Symbicort; Dulera

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.
    

Eligibility 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.