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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00913328
First Posted: June 4, 2009
Last Update Posted: June 4, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hvidovre University Hospital
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Changes from baseline in PD20 methacholine [ Time Frame: After 12 weeks of treatment ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: June 3, 2009
First Posted: June 4, 2009
Last Update Posted: June 4, 2009
Last Verified: June 2009

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
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action