Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 134
Healthy volunteers: no

Brief summary:
This study assesses inhaled corticosteroid plus montelukast compared with inhaled corticosteroid therapy alone for treatment of patients with chronic asthma.

Detailed description:
During this study, all patients will receive mometasone (powder, 220 mcg once-daily, for approximately 6 weeks). In a crossover manner, eligible patients will also receive montelukast (powder, 1 mg once-daily, for approximately 2 weeks) followed by placebo; or will receive placebo followed by montelukast. The order of when each of these 2 treatments are added to the mometasone will be randomized.

Arms:
arm 1: mometasone arm 2: montelukast followed by placebo; or placebo followed by montelukast.

Interventions: intervention 1: Comparator: mometasone intervention 2: Comparator: montelukast intervention 3: Comparator: placebo (unspecified)
Intervention descriptions: intervention 1: mometasone (inhalation powder, 220 mcg once-daily, for approximately 6 weeks) intervention 2: montelukast (inhalation powder, 1 mg once-daily, for approximately 2 weeks) intervention 3: Placebo (Placebo once-daily, for approximately 2 weeks)

Protocol document: