Asthma
Conditions
Keywords
Asthma, Airway responsiveness, Dose-response plateau, Montelukast, Add-on to inhaled corticosteroids
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.
Interventions
10 mg tablet once daily
DRUGPlacebo
Oral placebo once daily
Sponsors
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline in maximal FEV1 decline at the dose-response plateau | After 12 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in PD20 methacholine | After 12 weeks of treatment |
Outcome results
None listed