Phase 2
N=134
Study of Inhaled Corticosteroid Plus Montelukast Compared With Inhaled Corticosteroid Therapy Alone in Patients With Chronic Asthma (0476-386)
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00666679 ↗Enrolled (actual)
134
Serious AEs
0.8%
Results posted
Feb 2010
Primary outcome: Primary: Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation) — 0.22; 0.17 L (Liter) — p=0.033
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Comparator: mometasone (Drug); Comparator: montelukast (Drug); Comparator: placebo (unspecified) (Drug)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation) |
0.22; 0.17 | 0.033 sig |
| SECONDARY Change From Baseline in Daytime Asthma Symptom Score |
-0.39; -0.24 | 0.005 sig |
| SECONDARY Change From Baseline in Nighttime Asthma Symptom Score |
-0.28; -0.18 | 0.015 sig |
Summary
This study assesses inhaled corticosteroid plus montelukast compared with inhaled corticosteroid therapy alone for treatment of patients with chronic asthma.
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
Data sourced from ClinicalTrials.gov (NCT00666679). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.