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To Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy (0476-366)

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0476, montelukast sodium / Duration of Treatment: 12 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

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

Inclusion Criteria:

  • Allergic rhinitis symptoms: sneezing, rhinorrhea, obstruction of the nasal passages, itchy nose and throat, and conjunctival
  • Male or female outpatient 20 years of age and older
  • Patients with the following signs and symptoms of asthma and allergic rhinitis: history of cough, wheezing, shortness of breath, positive methacholine bronchoprovocation test

Exclusion Criteria:

  • Active, acute or chronic, pulmonary disorder (besides asthma) documented by history, physical examination, or chest x-ray. history of anaphylactic or hypersensitive to study drug
  • Requires oral, intravenous, or intramuscular corticosteroids on daily routine basis
  • Started on immunotherapy within six months before the pre-study visit and/or the dose of immunotherapy is expected to change over the course of the study
  • Treated with montelukast within 3 months before enrollment
  • Unable to perform acceptable, reproducible spirometry and peak flow measurement
  • Unresolved symptoms and signs of an upper respiratory tract infection (uri) within 2 weeks prior to visit 1

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Ltd4 in urine and eosinophil from peripheral blood over 3 months of therapy

    Secondary Outcome Measures

    Asthma symptoms score throughout the study

    Full Information

    First Posted
    November 9, 2006
    Last Updated
    January 31, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00398151
    Brief Title
    To Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy (0476-366)
    Official Title
    An Open-Label Study to Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2005 (Actual)
    Primary Completion Date
    January 18, 2006 (Actual)
    Study Completion Date
    January 18, 2006 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    To evaluate the changes in proinflammatory markers (ltd4 in urine) and eosinophil from peripheral blood after newly initiated montelukast therapy.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    58 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0476, montelukast sodium / Duration of Treatment: 12 Weeks
    Primary Outcome Measure Information:
    Title
    Ltd4 in urine and eosinophil from peripheral blood over 3 months of therapy
    Secondary Outcome Measure Information:
    Title
    Asthma symptoms score throughout the study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Allergic rhinitis symptoms: sneezing, rhinorrhea, obstruction of the nasal passages, itchy nose and throat, and conjunctival Male or female outpatient 20 years of age and older Patients with the following signs and symptoms of asthma and allergic rhinitis: history of cough, wheezing, shortness of breath, positive methacholine bronchoprovocation test Exclusion Criteria: Active, acute or chronic, pulmonary disorder (besides asthma) documented by history, physical examination, or chest x-ray. history of anaphylactic or hypersensitive to study drug Requires oral, intravenous, or intramuscular corticosteroids on daily routine basis Started on immunotherapy within six months before the pre-study visit and/or the dose of immunotherapy is expected to change over the course of the study Treated with montelukast within 3 months before enrollment Unable to perform acceptable, reproducible spirometry and peak flow measurement Unresolved symptoms and signs of an upper respiratory tract infection (uri) within 2 weeks prior to visit 1
    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

    To Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy (0476-366)

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