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

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ClinicalTrials.gov Identifier: NCT00913328
Recruitment Status : Completed
First Posted : June 4, 2009
Last Update Posted : June 4, 2009
Sponsor:
Information provided by:
Hvidovre University Hospital

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Asthma Drug: Montelukast (Singulair) Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
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
Study Start Date : August 2002
Actual Primary Completion Date : May 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Changes from baseline in maximal FEV1 decline at the dose-response plateau [ Time Frame: After 12 weeks of treatment ]

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

Eligibility Criteria
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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
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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
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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
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Responsible Party: Ass. prof. of Medicine Charlotte Suppli Ulrik, Department of Heart and Lung Diseases, Hvidovre Hospital
ClinicalTrials.gov Identifier: NCT00913328    
Other Study ID Numbers: SINGDEN-04-2002
First Posted: June 4, 2009    Key Record Dates
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:
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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