Conditions: Asthma
Keywords: Asthma Asthma Control
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 500
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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).

Arms:
arm 1: Participants continued fluticasone (100 microgram twice daily) treatment. arm 2: Participants were changed to Montelukast (5 or 10 mg each night). arm 3: Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.

Interventions: intervention 1: fluticasone intervention 2: montelukast intervention 3: Fluticasone plus salmeterol
Intervention descriptions: intervention 1: fluticasone (100 microgram twice daily) treatment intervention 2: Montelukast (5 or 10 mg each night). intervention 3: fluticasone (100 microgram) plus salmeterol (50 microgram) each night

Protocol document: