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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: montelukast sodium
* Drug: Comparator: loratadine
* Drug: Comparator: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>montelukast | Drug: montelukast sodium<br>* montelukast 10 mg tablet orally once daily in the morning for 4 weeks<br>|
| Active Comparator: 2<br>loratadine | Drug: Comparator: loratadine<br>* loratadine 10 mg tablet orally once daily in the morning for 4 weeks<br>|
| Placebo Comparator: 3<br>placebo | Drug: Comparator: placebo<br>* placebo tablet orally once daily in the morning for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) | 
| 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)]. | Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) | 
| 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. | Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) | 
| 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. | After first 2 weeks of treatment | 
| 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. | After first 2 weeks of treatment | 
| 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. | Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2) |