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