Back to resultsMontelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246)
Primary Purpose
Perennial Allergic Rhinitis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
montelukast sodium
Comparator: cetirizine
Comparator: placebo
Sponsored by
About this trial
This is an interventional treatment trial for Perennial Allergic Rhinitis
Eligibility Criteria
Inclusion Criteria:
- Patient has a documented clinical history of perennial allergic rhinitis
- 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 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
cetirizine
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 nasal symptom 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
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 (worst)], and the average 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
Composite Symptoms Scores were computed as the average of the Daytime Nasal Symptoms Scores [Score 0 (best) to 3 (worst)]. and Nighttime Symptoms Scores collected [Score 0 (best) to 3 (worst)].
Patient's Global Evaluation of Allergic Rhinitis
An evaluation by the patient, administered at week 4 of the study (or upon discontinuation) 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
An evaluation by the physician, administered at week 4 of the study (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00974571
Brief Title
Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246)
Official Title
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Investigating the Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
May 2002 (Actual)
Study Completion Date
May 2002 (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 assess the ability of montelukast to improve the signs and symptoms of perennial allergic rhinitis compared to placebo. Cetirizine 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
Perennial Allergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1365 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
montelukast
Arm Title
2
Arm Type
Active Comparator
Arm Description
cetirizine
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 6 weeks
Intervention Type
Drug
Intervention Name(s)
Comparator: cetirizine
Intervention Description
cetirizine 10 mg tablet orally once daily at bedtime for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Comparator: placebo
Intervention Description
placebo tablet orally once daily at bedtime for 6 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 nasal symptom 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 first 4 weeks of a 6-week treatment period
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 [Score 0 (best) to 3 (worst)], and the average 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 4 weeks in 6-week treatment period
Title
Mean Change From Baseline in Composite Symptoms Score
Description
Composite Symptoms Scores were computed as the average of the Daytime Nasal Symptoms Scores [Score 0 (best) to 3 (worst)]. and Nighttime Symptoms Scores collected [Score 0 (best) to 3 (worst)].
Time Frame
Baseline and first 4 weeks in 6-week treatment period
Title
Patient's Global Evaluation of Allergic Rhinitis
Description
An evaluation by the patient, administered at week 4 of the study (or upon discontinuation) 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
End of the first 4 weeks in 6-week treatment period
Title
Physician's Global Evaluation of Allergic Rhinitis
Description
An evaluation by the physician, administered at week 4 of the study (or upon discontinuation) 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
End of the first 4 weeks in 6-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 clinical history of perennial allergic rhinitis
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 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
17619558
Citation
Philip G, Williams-Herman D, Patel P, Weinstein SF, Alon A, Gilles L, Tozzi CA, Dass SB, Reiss TF. Efficacy of montelukast for treating perennial allergic rhinitis. Allergy Asthma Proc. 2007 May-Jun;28(3):296-304. doi: 10.2500/aap.2007.28.3000.
Results Reference
result
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Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246)
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