Effect of Add-on Montelukast to Inhaled Corticosteroids on Airway Responsiveness

Hvidovre University Hospital31 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Asthma

Interventions

Montelukast (Singulair)DRUG

10 mg tablet once daily

PlaceboDRUG

Oral placebo once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Changes from baseline in maximal FEV1 decline at the dose-response plateau

Time frame: After 12 weeks of treatment

Secondary Outcomes

Changes from baseline in PD20 methacholine

Time frame: After 12 weeks of treatment

Data from ClinicalTrials.gov

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