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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

montelukast (Singulair)

Drug

10 mg tablet once daily

Other names: Singulair

Placebo

Drug

Oral placebo once daily

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

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

Effect of Add-on Montelukast to Inhaled Corticosteroids in Excessive Airway Narrowing in Adults With Asthma

Acronym: SINGDEN

Important dates

Study start: 2002
Primary completion: 2006
Study completion: 2006
First posted: Jun 4, 2009
Registry last updated: Jun 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed