At a glance
ClinicalIndex Comparison Record- ✓Physician-diagnosed asthma
- ✓Age 6 or older
- ✓Pre-bronchodilator FEV1 at least 60% of predicted
- ✓Beta-agonist reversibility OR airways hyperreactivity by methacholine challenge
- ✕Current or past smoking history greater than 20 pack-years
- ✕Chronic or current oral steroid therapy
- ✕Pregnancy or lactation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial
In Brief
A Phase 4 clinical trial evaluating fluticasone, montelukast, and 1 other intervention for Asthma. Completed, enrolled 500 participants across 19 sites.
Detailed 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.
Study Details
Timeline
Interventions
fluticasone (100 microgram twice daily) treatment
Montelukast (5 or 10 mg each night).
fluticasone (100 microgram) plus salmeterol (50 microgram) each night