Blacks and Exacerbations on Long Acting Beta Agonists (LABA) vs. Tiotropium (BELT)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      Asthma is a chronic respiratory disease that affects over 22 million people in the United
      States. Asthma produces 500,000 hospital admissions and accounts for 10.1 million days of
      lost work in adults annually. Asthma has been designated a priority condition of the
      Effective Health Care Program.

      Blacks bear a disproportionate burden of asthma morbidity and mortality. In its 2005 report
      on ethnic disparities in health care, AHRQ identified hospital admissions for asthma as the
      second largest disparity in quality of health care for Blacks vs. Caucasians.

      Long-acting beta-agonists (LABAs) produce extended increases in airway caliber among patients
      with asthma via action at the beta2-adrenergic receptor (ADRB2). Adding a LABA to an inhaled
      corticosteroid controller medication (ICS), can decrease asthma symptoms for many individuals
      and appears to decrease asthma exacerbations. LABA/ICS has become the most commonly
      prescribed ICS containing medication.

      Drugs acting at ADRB2, including LABAs, have been associated with rare loss of long-term
      asthma control and increased serious adverse outcomes including death and respiratory
      failure, even when used with ICS. The risk appears four to five-fold greater in Blacks than
      non-Black patients with asthma.

      Consensus guidelines recommend LABAs be added to ICS in those not completely controlled on
      ICS alone. These recommendations are based on weighing data on the benefit demonstrated in
      the general population vs. the rare risk of serious adverse outcomes and balancing the
      apparent benefits vs. the risks of LABAs (Kramer 2009). However, it appears that LABA/ICS may
      be significantly less effective in Blacks than Caucasians. Comparison of studies with
      LABA/ICS in Blacks vs. studies where Blacks were a small minority suggests that Blacks may
      have much less benefit than other racial groups. Additionally, recent data (Wechsler 2009)
      suggest that a polymorphism at the 16th position of the ADRB2 gene identifies a group of
      Blacks (those homozygous for arginine (Arg16Arg)) in whom the response of adding a LABA to an
      ICS is further diminished. This polymorphism is present in ~20% of US Blacks.
    

Intervention name(s): Tiotropium; Salmeterol; Formoterol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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
Other intervention name(s): Spiriva; Serevent; Foradil
Intervention MeSH terms: Formoterol Fumarate; Tiotropium Bromide; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; Blacks; LABA; Tiotropium; Spiriva; African American; Serevent; salmeterol; Foradil; formoterol; Advair; Symbicort; Dulera