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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Montelukast (Singulair)
Placebo
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Airway responsiveness, Dose-response plateau, Montelukast, Add-on to inhaled corticosteroids

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Montelukast

    Placebo

    Arm Description

    Oral montelukast 10 mg once daily for 12 weeks

    Oral placebo once daily for 12 weeks

    Outcomes

    Primary Outcome Measures

    Changes from baseline in maximal FEV1 decline at the dose-response plateau

    Secondary Outcome Measures

    Changes from baseline in PD20 methacholine

    Full Information

    First Posted
    June 3, 2009
    Last Updated
    June 3, 2009
    Sponsor
    Hvidovre University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00913328
    Brief Title
    Effect of Add-on Montelukast to Inhaled Corticosteroids on Airway Responsiveness
    Acronym
    SINGDEN
    Official Title
    Effect of Add-on Montelukast to Inhaled Corticosteroids in Excessive Airway Narrowing in Adults With Asthma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2002 (undefined)
    Primary Completion Date
    May 2006 (Actual)
    Study Completion Date
    October 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Hvidovre University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma
    Keywords
    Asthma, Airway responsiveness, Dose-response plateau, Montelukast, Add-on to inhaled corticosteroids

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    31 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Montelukast
    Arm Type
    Active Comparator
    Arm Description
    Oral montelukast 10 mg once daily for 12 weeks
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Oral placebo once daily for 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Montelukast (Singulair)
    Other Intervention Name(s)
    Singulair
    Intervention Description
    10 mg tablet once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Oral placebo once daily
    Primary Outcome Measure Information:
    Title
    Changes from baseline in maximal FEV1 decline at the dose-response plateau
    Time Frame
    After 12 weeks of treatment
    Secondary Outcome Measure Information:
    Title
    Changes from baseline in PD20 methacholine
    Time Frame
    After 12 weeks of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zuzana Diamant, MD, PhD
    Organizational Affiliation
    Erasmus Medical Center
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Charlotte S Ulrik, MD, DMSc
    Organizational Affiliation
    Dept. of Heart and Lung Diseases, Hvidovre Hospital, Denmark
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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