Randomized, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Inhaled Corticosteroid Plus Montelukast Compared With Inhaled Corticosteroid Therapy Alone in Patients With Chronic Asthma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Asthma
- Sponsor
- Organon and Co
- Enrollment
- 134
- Primary Endpoint
- Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation)
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient has decreased breathing capacity (when not taking asthma medicine) that improves after taking a fast-acting asthma inhaler
- •Within one month of the first study visit, patient has been treated with a fast-acting asthma inhaler, and may be treated with a corticosteroid inhaler or an inhaler that combines a corticosteroid plus a bronchodilator
Exclusion Criteria
- •Patient is hypersensitive to inhaled beta-agonists, corticosteroids, leukotriene antagonists, or any of their components
- •Has required an oral corticosteroid rescue for worsening asthma during the screening period
Outcomes
Primary Outcomes
Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation)
Time Frame: Baseline and 2 weeks
To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on bronchodilation assessed by average change from baseline in FEV1 over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.
Secondary Outcomes
- Change From Baseline in Daytime Asthma Symptom Score(Baseline and 2 weeks)
- Change From Baseline in Nighttime Asthma Symptom Score(Baseline and 2 weeks)