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Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117)

Primary Purpose

Seasonal Allergic Rhinitis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Comparator: montelukast/loratadine
Comparator: montelukast
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 seasonal 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 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
  • Patient has any active pulmonary disorder other than asthma

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    3

    4

    Arm Description

    montelukast/loratadine

    loratadine

    montelukast

    placebo

    Outcomes

    Primary Outcome Measures

    Mean Change From Baseline in Daytime Nasal Symptoms Score
    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 (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
    Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale (0 (best) to 3 (worst)), and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score.
    Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms)
    Composite Symptoms scores were computed as the average of the Daytime Nasal Symptoms scores and Nighttime Symptoms scores collected on a 4 point scale (0 (best) to 3 (worst)).
    Mean Change From Baseline in Daytime Eye Symptoms Score
    Mean change from baseline in Daytime Eye Symptoms scores. Patients were asked to rate each of the 4 eye symptom 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.
    Mean Change From Baseline in Daytime Nasal Congestion Score
    Patients were asked to rate the nasal symptom of Congestion daily on a 4-point scale (0 (best) to 3 (worst)).
    Mean Change From Baseline in Daytime Rhinorrhea Score
    Patients were asked to rate the nasal symptom of Rhinorrhea daily on a 4-point scale (0 (best) to 3 (worst)).
    Mean Change From Baseline in Daytime Nasal Itching Score
    Patients were asked to rate the nasal symptom of Nasal Itching daily on a 4-point scale (0 (best) to 3 (worst)).
    Mean Change From Baseline in Daytime Sneezing Score
    Patients were asked to rate the nasal symptom of Sneezing daily on a 4-point scale (0 (best) to 3 (worst)).
    Mean Change From Baseline in Nasal Congestion Upon Awakening
    Patients were asked to rate the symptom of Nasal Congestion Upon Awakening daily on a 4-point scale (0 (best) to 3 (worst)).
    Patient's Global Evaluation of Allergic Rhinitis
    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. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).
    Physician's Global Evaluation of Allergic Rhinitis
    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. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).
    Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score
    Patients completed a Rhinoconjunctivitis Quality-of-Life Questionnaire, 28 questions on a 7-point scale [0(best) to 6(worst)] across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, emotional. Scores per domain were averaged, then scores for the 7 domains were averaged for an overall score.

    Full Information

    First Posted
    August 19, 2009
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00963599
    Brief Title
    Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117)
    Official Title
    A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effect of Combination Montelukast/Loratadine in Patients With Seasonal Allergic Rhinitis-Fall Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1999 (undefined)
    Primary Completion Date
    November 1999 (Actual)
    Study Completion Date
    November 1999 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    This study will evaluate the ability of oral montelukast/loratadine to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine alone, montelukast alone 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
    907 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    montelukast/loratadine
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    loratadine
    Arm Title
    3
    Arm Type
    Experimental
    Arm Description
    montelukast
    Arm Title
    4
    Arm Type
    Placebo Comparator
    Arm Description
    placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: montelukast/loratadine
    Intervention Description
    montelukast 10 mg/loratadine 10 mg tablet taken once daily at bed time for 2 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: montelukast
    Intervention Description
    montelukast 10 mg tablet taken once daily at bed time for 2 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: loratadine
    Intervention Description
    loratadine 10 mg tablet taken once daily at bed time for 2 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: placebo
    Intervention Description
    placebo tablet taken once daily at bed time for 2 weeks
    Primary Outcome Measure Information:
    Title
    Mean Change From Baseline in Daytime Nasal Symptoms Score
    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 (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 Week 2
    Secondary Outcome Measure Information:
    Title
    Mean Change From Baseline in Nighttime Symptoms Score
    Description
    Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale (0 (best) to 3 (worst)), and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score.
    Time Frame
    Baseline and Week 2
    Title
    Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms)
    Description
    Composite Symptoms scores were computed as the average of the Daytime Nasal Symptoms scores and Nighttime Symptoms scores collected on a 4 point scale (0 (best) to 3 (worst)).
    Time Frame
    Baseline and Week 2
    Title
    Mean Change From Baseline in Daytime Eye Symptoms Score
    Description
    Mean change from baseline in Daytime Eye Symptoms scores. Patients were asked to rate each of the 4 eye symptom 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 Week 2
    Title
    Mean Change From Baseline in Daytime Nasal Congestion Score
    Description
    Patients were asked to rate the nasal symptom of Congestion daily on a 4-point scale (0 (best) to 3 (worst)).
    Time Frame
    Baseline and Week 2
    Title
    Mean Change From Baseline in Daytime Rhinorrhea Score
    Description
    Patients were asked to rate the nasal symptom of Rhinorrhea daily on a 4-point scale (0 (best) to 3 (worst)).
    Time Frame
    Baseline and Week 2
    Title
    Mean Change From Baseline in Daytime Nasal Itching Score
    Description
    Patients were asked to rate the nasal symptom of Nasal Itching daily on a 4-point scale (0 (best) to 3 (worst)).
    Time Frame
    Baseline and Week 2
    Title
    Mean Change From Baseline in Daytime Sneezing Score
    Description
    Patients were asked to rate the nasal symptom of Sneezing daily on a 4-point scale (0 (best) to 3 (worst)).
    Time Frame
    Baseline and Week 2
    Title
    Mean Change From Baseline in Nasal Congestion Upon Awakening
    Description
    Patients were asked to rate the symptom of Nasal Congestion Upon Awakening daily on a 4-point scale (0 (best) to 3 (worst)).
    Time Frame
    Baseline and Week 2
    Title
    Patient's Global Evaluation of Allergic Rhinitis
    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. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).
    Time Frame
    Week 2
    Title
    Physician's Global Evaluation of Allergic Rhinitis
    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. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).
    Time Frame
    Week 2
    Title
    Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score
    Description
    Patients completed a Rhinoconjunctivitis Quality-of-Life Questionnaire, 28 questions on a 7-point scale [0(best) to 6(worst)] across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, emotional. Scores per domain were averaged, then scores for the 7 domains were averaged for an overall score.
    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 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 Patient has any active pulmonary disorder other than 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

    Citations:
    PubMed Identifier
    12086367
    Citation
    Nayak AS, Philip G, Lu S, Malice MP, Reiss TF; Montelukast Fall Rhinitis Investigator Group. Efficacy and tolerability of montelukast alone or in combination with loratadine in seasonal allergic rhinitis: a multicenter, randomized, double-blind, placebo-controlled trial performed in the fall. Ann Allergy Asthma Immunol. 2002 Jun;88(6):592-600. doi: 10.1016/S1081-1206(10)61891-1.
    Results Reference
    result

    Learn more about this trial

    Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117)

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