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Montelukast in Patients With Seasonal Allergic Rhinitis - Spring 2000 Study (MK-0476A-162)(COMPLETED)

Primary Purpose

Seasonal Allergic Rhinitis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Comparator: montelukast
Comparator: loratadine
Comparator: placebo
Comparator: montelukast/loratadine
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis

Eligibility Criteria

15 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient has a documented history of seasonal allergic rhinitis symptoms that flare up during the study season
  • Patient is a nonsmoker and has been a nonsmoker for at least 1 year
  • Patient is in good general health

Exclusion Criteria:

  • Patient is hospitalized
  • Patient is a woman who is less than 8 weeks postpartum or is breast-feeding
  • Patient intends to move or vacation away during the study
  • Patient has had any major surgery within 4 weeks of study start
  • Patient is a current or past abuser of alcohol or illicit drugs
  • Patient has been treated in an emergency room for asthma in the past month
  • Patient had an upper respiratory infection with in 3 weeks prior to study start

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Experimental

    Arm Label

    1

    2

    3

    4

    Arm Description

    montelukast

    loratadine

    placebo

    montelukast/loratadine

    Outcomes

    Primary Outcome Measures

    Mean Change From Baseline in Daytime Nasal Symptoms Score Over 2 Weeks
    Mean change from baseline in Daytime Nasal Symptoms score. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score. Scores were measured as 0 (best) to 3 (worst).

    Secondary Outcome Measures

    Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks
    Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale, and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score. Scores were measured as 0 (best) to 3 (worst).
    Mean Change From Baseline in Daytime Eye Symptoms Score Over 2 Weeks
    Mean change from baseline in Daytime Eye Symptoms scores. Patients were asked to rate each of the 4 eye symptoms of tearing, itchy, red, and puffy eyes daily on a 4-point scale. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score. Scores were measured as 0 (best) to 3 (worst).
    Patient's Global Evaluation of Allergic Rhinitis at Week 2
    An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Scores were measured as 0 (best) to 6 (worst).
    Physician's Global Evaluation of Allergic Rhinitis at Week 2
    An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Scores were measured as 0 (best) to 6 (worst).
    Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score at Week 2
    Patients completed the validated, self-administered RQLQ, which included 28 items on a 7-point scale across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Scores for each domain were averaged, then scores for the 7 domains were averaged for the overall score. Scores were measured as 0 (best) to 6 (worst).

    Full Information

    First Posted
    September 17, 2009
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00979901
    Brief Title
    Montelukast in Patients With Seasonal Allergic Rhinitis - Spring 2000 Study (MK-0476A-162)(COMPLETED)
    Official Title
    A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effects of Montelukast in Patients With Seasonal Allergic Rhinitis--Spring Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2000 (undefined)
    Primary Completion Date
    May 2000 (Actual)
    Study Completion Date
    May 2000 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will evaluate the ability of montelukast to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine and placebo.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1577 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    montelukast
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    loratadine
    Arm Title
    3
    Arm Type
    Placebo Comparator
    Arm Description
    placebo
    Arm Title
    4
    Arm Type
    Experimental
    Arm Description
    montelukast/loratadine
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: montelukast
    Intervention Description
    10 mg montelukast tablet given once daily at bedtime for 2 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: loratadine
    Intervention Description
    10 mg loratadine tablet given once daily at bedtime for 2 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: placebo
    Intervention Description
    placebo tablet given once daily at bedtime for 2 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: montelukast/loratadine
    Intervention Description
    montelukast 10-mg/loratadine 10-mg combination tablet taken orally once daily at bedtime for 2 weeks
    Primary Outcome Measure Information:
    Title
    Mean Change From Baseline in Daytime Nasal Symptoms Score Over 2 Weeks
    Description
    Mean change from baseline in Daytime Nasal Symptoms score. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score. Scores were measured as 0 (best) to 3 (worst).
    Time Frame
    Baseline and Week 2
    Secondary Outcome Measure Information:
    Title
    Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks
    Description
    Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale, and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score. Scores were measured as 0 (best) to 3 (worst).
    Time Frame
    Baseline and Week 2
    Title
    Mean Change From Baseline in Daytime Eye Symptoms Score Over 2 Weeks
    Description
    Mean change from baseline in Daytime Eye Symptoms scores. Patients were asked to rate each of the 4 eye symptoms of tearing, itchy, red, and puffy eyes daily on a 4-point scale. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score. Scores were measured as 0 (best) to 3 (worst).
    Time Frame
    Baseline and Week 2
    Title
    Patient's Global Evaluation of Allergic Rhinitis at Week 2
    Description
    An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Scores were measured as 0 (best) to 6 (worst).
    Time Frame
    Week 2
    Title
    Physician's Global Evaluation of Allergic Rhinitis at Week 2
    Description
    An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Scores were measured as 0 (best) to 6 (worst).
    Time Frame
    Week 2
    Title
    Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score at Week 2
    Description
    Patients completed the validated, self-administered RQLQ, which included 28 items on a 7-point scale across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Scores for each domain were averaged, then scores for the 7 domains were averaged for the overall score. Scores were measured as 0 (best) to 6 (worst).
    Time Frame
    Week 2

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient has a documented history of seasonal allergic rhinitis symptoms that flare up during the study season Patient is a nonsmoker and has been a nonsmoker for at least 1 year Patient is in good general health Exclusion Criteria: Patient is hospitalized Patient is a woman who is less than 8 weeks postpartum or is breast-feeding Patient intends to move or vacation away during the study Patient has had any major surgery within 4 weeks of study start Patient is a current or past abuser of alcohol or illicit drugs Patient has been treated in an emergency room for asthma in the past month Patient had an upper respiratory infection with in 3 weeks prior to study start
    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

    Citations:
    PubMed Identifier
    12100048
    Citation
    Philip G, Malmstrom K, Hampel FC, Weinstein SF, LaForce CF, Ratner PH, Malice MP, Reiss TF; Montelukast Spring Rhinitis Study Group. Montelukast for treating seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled trial performed in the spring. Clin Exp Allergy. 2002 Jul;32(7):1020-8. doi: 10.1046/j.1365-2222.2002.01422.x. Erratum In: Clin Exp Allergy. 2009 Oct;39(10):1622.
    Results Reference
    result

    Learn more about this trial

    Montelukast in Patients With Seasonal Allergic Rhinitis - Spring 2000 Study (MK-0476A-162)(COMPLETED)

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