Effect of Add-on Montelukast to Inhaled Corticosteroids on Airway Responsiveness (SINGDEN)

This study has been completed.
Sponsor:
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00913328
First received: June 3, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Montelukast (Singulair)
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Add-on Montelukast to Inhaled Corticosteroids in Excessive Airway Narrowing in Adults With Asthma

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Changes from baseline in maximal FEV1 decline at the dose-response plateau [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes from baseline in PD20 methacholine [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: August 2002
Study Completion Date: October 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Montelukast
Oral montelukast 10 mg once daily for 12 weeks
Drug: Montelukast (Singulair)
10 mg tablet once daily
Other Name: Singulair
Placebo Comparator: Placebo
Oral placebo once daily for 12 weeks
Drug: Placebo
Oral placebo once daily

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00913328

Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Principal Investigator: Zuzana Diamant, MD, PhD Erasmus Medical Center
Principal Investigator: Charlotte S Ulrik, MD, DMSc Dept. of Heart and Lung Diseases, Hvidovre Hospital, Denmark
  More Information

No publications provided

Responsible Party: Ass. prof. of Medicine Charlotte Suppli Ulrik, Department of Heart and Lung Diseases, Hvidovre Hospital
ClinicalTrials.gov Identifier: NCT00913328     History of Changes
Other Study ID Numbers: SINGDEN-04-2002
Study First Received: June 3, 2009
Last Updated: June 3, 2009
Health Authority: Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency

Keywords provided by Hvidovre University Hospital:
Asthma
Airway responsiveness
Dose-response plateau
Montelukast
Add-on to inhaled corticosteroids

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014