The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial
The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial
This research study will compare the treatment effects of three different asthma medications
 in asthma subjects whose asthma is well controlled when they take fluticasone, an inhaled
 corticosteroid. The treatments are fluticasone, montelukast (an anti?leukotriene drug), and a
 combination therapy of fluticasone and salmeterol (a long-acting beta-agonist). Fluticasone,
 montelukast, and the combination therapy of fluticasone and salmeterol (Advair Diskus®) are
 all approved for the treatment of asthma. We are looking at whether the three treatments are
 equally effective for reducing the number and the severity of asthma attacks in subjects with
 mild to moderately severe asthma.
This trial will attempt to investigate whether asthmatic patients that are well controlled
 with low-dose twice daily inhaled corticosteroid (ICS) therapy can safely be switched to
 other modes of controller therapy without loss of asthma control. Patients demonstrating good
 control on twice-daily low-dose ICS will be randomized to one of three treatment groups:
 once-daily low-dose ICS (fluticasone), leukotriene receptor antagonist (montelukast), or
 once-daily combination therapy (fluticasone-salmeterol).
Inclusion Criteria:

 -  physician-diagnosed asthma

 -  age 6 or older

 -  pre-bronchodilator forced expiratory volume (FEV1) of at least 60% of predicted

 -  beta-agonist reversibility OR airways hyperreactivity by methacholine challenge

 -  Juniper Asthma Control Score of 1.5 or greater if not on daily controller

 -  good current health

 Exclusion Criteria:

 -  current or past smoking (greater than 20 pack-years)

 -  chronic or current oral steroid therapy

 -  pregnancy, lack of effective contraception (when appropriate), lactation