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Quality of Life in Asthma and Rhinitis Allergic With Singulair (0476-365)

Primary Purpose

Asthma, Rhinitis Allergic

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
MK0476, Singulair, montelukast sodium / Duration of Treatment: 8 Weeks
Sponsored by
Organon and Co
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Establish diagnosis of mild to moderate chronic asthma and/or allergic rhinitis currently on treatment
  • Voluntary acceptance to participate in the study

Exclusion Criteria:

  • Patients with cystic fibrosis
  • Patients with known hypersensitivity to singulair or any of its components
  • Patients with severe chronic asthma

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Quality of life measures

    Secondary Outcome Measures

    Nocturnal wake up, work or school absences, physical activity and recurrence of asthma and/or rhinitis

    Full Information

    First Posted
    September 22, 2006
    Last Updated
    January 31, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00380705
    Brief Title
    Quality of Life in Asthma and Rhinitis Allergic With Singulair (0476-365)
    Official Title
    Quality of Life in Asthma and Rhinitis Allergic With Singulair
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    March 18, 2005 (Actual)
    Primary Completion Date
    July 29, 2005 (Actual)
    Study Completion Date
    July 29, 2005 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    5. Study Description

    Brief Summary
    Allow physicians not familiar with anti-leukotriene based therapy to test it

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma, Rhinitis Allergic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    91 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0476, Singulair, montelukast sodium / Duration of Treatment: 8 Weeks
    Primary Outcome Measure Information:
    Title
    Quality of life measures
    Secondary Outcome Measure Information:
    Title
    Nocturnal wake up, work or school absences, physical activity and recurrence of asthma and/or rhinitis

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Establish diagnosis of mild to moderate chronic asthma and/or allergic rhinitis currently on treatment Voluntary acceptance to participate in the study Exclusion Criteria: Patients with cystic fibrosis Patients with known hypersensitivity to singulair or any of its components Patients with severe chronic asthma
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

    Quality of Life in Asthma and Rhinitis Allergic With Singulair (0476-365)

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