Back to resultsA Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis (MK-0476-192)(COMPLETED)
Primary Purpose
Seasonal Allergic Rhinitis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
montelukast sodium
Comparator: loratadine
Comparator: placebo
Sponsored by
About this trial
This is an interventional treatment trial for Seasonal Allergic Rhinitis
Eligibility Criteria
Inclusion Criteria:
- Patient has a documented clinical history of seasonal allergic rhinitis symptoms that become worse during the study season
- Patient is a non-smoker
- Patient is in good mental and physical health
Exclusion Criteria:
- Patient is hospitalized
- Patient is a woman who is <8 weeks postpartum or is breast feeding
- 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
Mean change from baseline in Daytime Nasal Symptoms score on a 4-point scale [0(best) to 3(worst)]. The average of the 4 individual nasal symptoms scores (Congestion, Rhinorrhea, Itching, and Sneezing) 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 on a 4-point scale [0(best) to 3(worst)]. The average of 3 scores (Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings) was reported as the Nighttime Symptoms Score.
Mean Change From Baseline in Daytime Eye Symptoms Score
Mean change from baseline in Daytime Eye Symptoms scores on a 4-point scale [0(best) to 3(worst)]. The average of the 4 individual eye symptoms scores (tearing, itchy, red, and puffy eyes) was reported as the Daytime Eye Symptoms Score.
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, in answer to a single question regarding 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 validated, self-administered 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 scores for each domain were averaged, then the scores for the 7 domains were averaged for the overall score.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00960141
Brief Title
A Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis (MK-0476-192)(COMPLETED)
Official Title
A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effect of Montelukast 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
August 2000 (undefined)
Primary Completion Date
October 2000 (Actual)
Study Completion Date
November 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
A study of the ability of montelukast to improve signs and symptoms of seasonal allergic rhinitis compared with placebo. 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
829 (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, taken orally once daily at bed time for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Comparator: loratadine
Intervention Description
loratadine 10 mg tablet, taken orally once daily at bed time for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Comparator: placebo
Intervention Description
placebo tablet, taken orally 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 on a 4-point scale [0(best) to 3(worst)]. The average of the 4 individual nasal symptoms scores (Congestion, Rhinorrhea, Itching, and Sneezing) 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 on a 4-point scale [0(best) to 3(worst)]. The average of 3 scores (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
Mean Change From Baseline in Daytime Eye Symptoms Score
Description
Mean change from baseline in Daytime Eye Symptoms scores on a 4-point scale [0(best) to 3(worst)]. The average of the 4 individual eye symptoms scores (tearing, itchy, red, and puffy eyes) was reported as the Daytime Eye Symptoms Score.
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, in answer to a single question regarding 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 (or upon discontinuation)
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 validated, self-administered 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 scores for each domain were averaged, then the scores for the 7 domains were averaged for the overall score.
Time Frame
Baseline and 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 clinical history of seasonal allergic rhinitis symptoms that become worse during the study season
Patient is a non-smoker
Patient is in good mental and physical health
Exclusion Criteria:
Patient is hospitalized
Patient is a woman who is <8 weeks postpartum or is breast feeding
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
15049402
Citation
Chervinsky P, Philip G, Malice MP, Bardelas J, Nayak A, Marchal JL, van Adelsberg J, Bousquet J, Tozzi CA, Reiss TF. Montelukast for treating fall allergic rhinitis: effect of pollen exposure in 3 studies. Ann Allergy Asthma Immunol. 2004 Mar;92(3):367-73. doi: 10.1016/S1081-1206(10)61576-1.
Results Reference
result
Learn more about this trial
A Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis (MK-0476-192)(COMPLETED)
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