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

NCT00913328 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2009-06-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Montelukast (Singulair)

10 mg tablet once daily

DRUG

Placebo

Oral placebo once daily

Sponsors & Collaborators

  • Hvidovre University Hospital

    lead OTHER

Principal Investigators

  • Zuzana Diamant, MD, PhD · Erasmus Medical Center

  • Charlotte S Ulrik, MD, DMSc · Dept. of Heart and Lung Diseases, Hvidovre Hospital, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-08-31
Primary Completion
2006-05-31
Completion
2006-10-31

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00913328 on ClinicalTrials.gov