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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
This study assesses inhaled corticosteroid plus montelukast compared with inhaled corticosteroid therapy alone for treatment of patients with chronic asthma.
Details
| Lead sponsor | Organon and Co |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 134 |
| Start date | 2008-05 |
| Completion | 2009-02 |
Conditions
- Asthma
Interventions
- Comparator: mometasone
- Comparator: montelukast
- Comparator: placebo (unspecified)
Primary outcomes
- Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation) — 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.