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Montelukast in Seasonal Allergic Rhinitis: Fall 2001 Study (0476-240)

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 history of seasonal allergic rhinitis that worsens during the study season
  • Patient is a nonsmoker
  • Patient is in good health physical and mental health

Exclusion Criteria:

  • Patient is hospitalized
  • Patient is a woman who is < 8 weeks postpartum or is breastfeeding
  • Patient plans to move or vacation away during the study
  • Patient has had any major surgery with in past 4 weeks
  • 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 First 2 Weeks of Treatment Period
    Mean change from baseline in Daytime Nasal Symptoms Score. Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4- point scale [Score 0 (best) to 3 (worse)]. 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 First 2 Weeks of Treatment Period
    Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale [Score 0 (best) to 3 (worse)], and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score.
    Mean Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period
    Composite Symptoms Scores were computed as the average of Daytime Nasal Scores [Score 0 (best) to 3 (worst)] and Nighttime Symptoms Scores [Score 0 (best) to 3 (worst)].
    Mean Change From Baseline in Daytime Eye Symptoms Score Over First 2 Weeks of Treatment Period
    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 [Score 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 After First 2 Weeks of Treatment
    An evaluation by the patient, administered after the first 2 weeks of treatment using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.
    Physician's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment
    An evaluation by the physician, administered after the first 2 weeks of treatment using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.
    Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After First 2 Weeks of Treatment Period
    Patients completed a Rhinoconjunctivitis Quality-of-Life Questionnaire-28 questions on a 7-point scale [0(best) to 6(worst)] across 7 domains: activity,sleep,non-nose/eye symptoms,practical problems,nasal symptoms, eye symptoms, and emotions. The scores for each 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 1, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00963469
    Brief Title
    Montelukast in Seasonal Allergic Rhinitis: Fall 2001 Study (0476-240)
    Official Title
    A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effect of Montelukast in Patients With Seasonal Allergic Rhinitis Over a 4-Week Treatment Period-Fall 2001
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2001 (undefined)
    Primary Completion Date
    November 2001 (Actual)
    Study Completion Date
    November 2001 (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 is a study to evaluate the treatment effect of montelukast 10 mg taken in the morning, versus placebo, in patients with seasonal allergic rhinitis. Loratadine is included in the study as an active control.

    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
    1079 (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 in the morning for 4 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: loratadine
    Intervention Description
    loratadine 10 mg tablet orally once daily in the morning for 4 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: placebo
    Intervention Description
    placebo tablet orally once daily in the morning for 4 weeks
    Primary Outcome Measure Information:
    Title
    Mean Change From Baseline in Daytime Nasal Symptoms Score Over First 2 Weeks of Treatment Period
    Description
    Mean change from baseline in Daytime Nasal Symptoms Score. Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4- point scale [Score 0 (best) to 3 (worse)]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.
    Time Frame
    Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)
    Secondary Outcome Measure Information:
    Title
    Mean Change From Baseline in Nighttime Symptoms Score Over First 2 Weeks of Treatment Period
    Description
    Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale [Score 0 (best) to 3 (worse)], 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 first 2 Weeks of treatment period (from randomization through the end of Week 2)
    Title
    Mean Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period
    Description
    Composite Symptoms Scores were computed as the average of Daytime Nasal Scores [Score 0 (best) to 3 (worst)] and Nighttime Symptoms Scores [Score 0 (best) to 3 (worst)].
    Time Frame
    Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)
    Title
    Mean Change From Baseline in Daytime Eye Symptoms Score Over First 2 Weeks of Treatment Period
    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 [Score 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 first 2 Weeks of treatment period (from randomization through the end of Week 2)
    Title
    Patient's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment
    Description
    An evaluation by the patient, administered after the first 2 weeks of treatment using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.
    Time Frame
    After first 2 weeks of treatment
    Title
    Physician's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment
    Description
    An evaluation by the physician, administered after the first 2 weeks of treatment using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.
    Time Frame
    After first 2 weeks of treatment
    Title
    Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After First 2 Weeks of Treatment Period
    Description
    Patients completed a Rhinoconjunctivitis Quality-of-Life Questionnaire-28 questions on a 7-point scale [0(best) to 6(worst)] across 7 domains: activity,sleep,non-nose/eye symptoms,practical problems,nasal symptoms, eye symptoms, and emotions. The scores for each domain were averaged, then scores for the 7 domains were averaged for an overall score.
    Time Frame
    Baseline and first 2 Weeks of treatment period (from randomization through the end of 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 history of seasonal allergic rhinitis that worsens during the study season Patient is a nonsmoker Patient is in good health physical and mental health Exclusion Criteria: Patient is hospitalized Patient is a woman who is < 8 weeks postpartum or is breastfeeding Patient plans to move or vacation away during the study Patient has had any major surgery with in past 4 weeks 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
    14616102
    Citation
    van Adelsberg J, Philip G, Pedinoff AJ, Meltzer EO, Ratner PH, Menten J, Reiss TF; Montelukast Fall Rhinitis Study Group. Montelukast improves symptoms of seasonal allergic rhinitis over a 4-week treatment period. Allergy. 2003 Dec;58(12):1268-76. doi: 10.1046/j.1398-9995.2003.00261.x. Erratum In: Allergy. 2004 Mar;59(3):357. Allergy. 2009 Nov;64(11):1697.
    Results Reference
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    Montelukast in Seasonal Allergic Rhinitis: Fall 2001 Study (0476-240)

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