Effect of Add-on Montelukast to Inhaled Corticosteroids on Airway Responsiveness
- Registration Number
- NCT00913328
- Lead Sponsor
- Hvidovre University Hospital
- Brief Summary
Leukotriene receptor antagonists appear to posses additive anti-inflammatory effects to the effect of inhaled corticosteroids.
Hypothesis: Treatment with oral montelukast will lower the dose-response plateau to inhaled methacholine in patients with mild to moderate persistent asthma treated with a stable dose of inhaled corticosteroids.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
Inclusion Criteria
-
Non-smoking adults with mild to moderate persistent asthma:
- FEV1 > 70 % pred
- PD20 methacholine < 3.9 mmol
- treated for at least 3 months with a stable dose of inhaled corticosteroids
-
Documented dose-response plateau to inhaled methacholine on two occasions
-
Males and non-pregnant females
Exclusion Criteria
- Asthma medication other than inhaled corticosteroids and inhaled b2-agonists
- Viral respiratory tract infections within the 3 weeks prior to enrollment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Montelukast Montelukast (Singulair) Oral montelukast 10 mg once daily for 12 weeks Placebo Placebo Oral placebo once daily for 12 weeks
- Primary Outcome Measures
Name Time Method Changes from baseline in maximal FEV1 decline at the dose-response plateau After 12 weeks of treatment
- Secondary Outcome Measures
Name Time Method Changes from baseline in PD20 methacholine After 12 weeks of treatment