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Montelukast in Seasonal Allergic Rhinitis - Spring 2001 Study (0476-235)

Primary Purpose

Seasonal Allergic Rhinitis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
montelukast sodium
Comparator: loratadine
Comparator: Placebo
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 season allergic rhinitis symptoms that flare up during the study season
  • Patient is a nonsmoker
  • Patient is in good general health

Exclusion Criteria:

  • Patient is hospitalized
  • Patient is a woman who is <8 weeks postpartum or is breast-feeding
  • Patient has had major surgery in the past 4 weeks
  • Patient intends to move or vacation away during the study
  • Patient is a current or past abuser of alcohol or illicit drugs

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    1

    2

    3

    Arm Description

    montelukast

    loratadine

    placebo

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Mean Change From Baseline in Nighttime Symptoms Score Over the 2-week Treatment Period
    Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptoms of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings daily on a 4-point [Scale 0 (best) to 3 (worst)]. The average of the individual symptoms scores was reported as the Nighttime Symptoms Score.
    Mean Change From Baseline in Daytime Eye Symptoms Score Over the 2-week Treatment Period
    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 [0 (best) to 3 (worst)]. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score.
    Patient's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period
    An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (very much better) to 6 (very much worse)], of the change in symptoms as compared to the beginning of the study.
    Physician's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period
    An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (very much better) to 6 (very much worse)], of the change in symptoms as compared to the beginning of the study.
    Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After the 2-week Treatment Period
    Patients completed a validated, self-administered Rhinoconjunctivitis Quality-of-Life Questionnaire, which included 28 questions on a 7-point scale [Score 0 (best) to 6 (worst)], across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The individual domain scores were calculated as the average values of all scores within a domain, then the scores for the 7 domains were averaged for the overall score.

    Full Information

    First Posted
    September 4, 2009
    Last Updated
    February 1, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00972738
    Brief Title
    Montelukast in Seasonal Allergic Rhinitis - Spring 2001 Study (0476-235)
    Official Title
    A Multi-Center, Double-blind, Randomized, Parallel-Group Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis-Spring 2001 Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2001 (undefined)
    Primary Completion Date
    July 2001 (Actual)
    Study Completion Date
    July 2001 (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 assess the treatment effect of montelukast versus placebo over a 2 week period in patients with seasonal allergic rhinitis. Loratadine is included in the study as an active comparator.

    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
    1214 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    montelukast
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    loratadine
    Arm Title
    3
    Arm Type
    Placebo Comparator
    Arm Description
    placebo
    Intervention Type
    Drug
    Intervention Name(s)
    montelukast sodium
    Intervention Description
    Montelukast 10-mg tablet orally once daily at bedtime for 2 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: loratadine
    Intervention Description
    Loratadine 10-mg tablet orally once daily at bedtime for 2 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo
    Intervention Description
    placebo tablet orally once daily at bedtime for 2 weeks
    Primary Outcome Measure Information:
    Title
    Mean Change From Baseline in Daytime Nasal Symptoms Score Over the 2-week Treatment Period
    Description
    Mean change from baseline in Daytime Nasal Symptoms. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale [Score 0 (best) to 3 (worst)]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.
    Time Frame
    Baseline and over the 2-week treatment period
    Secondary Outcome Measure Information:
    Title
    Mean Change From Baseline in Nighttime Symptoms Score Over the 2-week Treatment Period
    Description
    Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptoms of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings daily on a 4-point [Scale 0 (best) to 3 (worst)]. The average of the individual symptoms scores was reported as the Nighttime Symptoms Score.
    Time Frame
    Baseline and over the 2-week treatment period
    Title
    Mean Change From Baseline in Daytime Eye Symptoms Score Over the 2-week Treatment Period
    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 [0 (best) to 3 (worst)]. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score.
    Time Frame
    Baseline and over the 2-week treatment period
    Title
    Patient's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period
    Description
    An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (very much better) to 6 (very much worse)], of the change in symptoms as compared to the beginning of the study.
    Time Frame
    End of the 2-week treatment period
    Title
    Physician's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period
    Description
    An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (very much better) to 6 (very much worse)], of the change in symptoms as compared to the beginning of the study.
    Time Frame
    End of the 2-week treatment period
    Title
    Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After the 2-week Treatment Period
    Description
    Patients completed a validated, self-administered Rhinoconjunctivitis Quality-of-Life Questionnaire, which included 28 questions on a 7-point scale [Score 0 (best) to 6 (worst)], across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The individual domain scores were calculated as the average values of all scores within a domain, then the scores for the 7 domains were averaged for the overall score.
    Time Frame
    Baseline and at the end of 2-week treatment period

    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 season allergic rhinitis symptoms that flare up during the study season Patient is a nonsmoker Patient is in good general health Exclusion Criteria: Patient is hospitalized Patient is a woman who is <8 weeks postpartum or is breast-feeding Patient has had major surgery in the past 4 weeks Patient intends to move or vacation away during the study Patient is a current or past abuser of alcohol or illicit drugs
    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
    12602669
    Citation
    van Adelsberg J, Philip G, LaForce CF, Weinstein SF, Menten J, Malice MP, Reiss TF; Montelukast Spring Rhinitis Investigator Group. Randomized controlled trial evaluating the clinical benefit of montelukast for treating spring seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2003 Feb;90(2):214-22. doi: 10.1016/S1081-1206(10)62144-8.
    Results Reference
    background

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    Montelukast in Seasonal Allergic Rhinitis - Spring 2001 Study (0476-235)

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