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
About this trial
This is an interventional treatment trial for Seasonal Allergic Rhinitis
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
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
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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