Montelukast in Patients With Seasonal Allergic Rhinitis - Spring 2000 Study (MK-0476A-162)(COMPLETED)

Organon and Co1,577 enrolled

Overview

This study will evaluate the ability of montelukast to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine and placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,577

Conditions

Seasonal Allergic Rhinitis

Interventions

Comparator: montelukastDRUG

10 mg montelukast tablet given once daily at bedtime for 2 weeks

Comparator: loratadineDRUG

10 mg loratadine tablet given once daily at bedtime for 2 weeks

Comparator: placeboDRUG

placebo tablet given once daily at bedtime for 2 weeks

Eligibility

Sex: ALLMin age: 15 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient has a documented history of seasonal allergic rhinitis symptoms that flare up during the study season * Patient is a nonsmoker and has been a nonsmoker for at least 1 year * Patient is in good general health Exclusion Criteria: * Patient is hospitalized * Patient is a woman who is less than 8 weeks postpartum or is breast-feeding * Patient intends to move or vacation away during the study * Patient has had any major surgery within 4 weeks of study start * Patient is a current or past abuser of alcohol or illicit drugs * Patient has been treated in an emergency room for asthma in the past month * Patient had an upper respiratory infection with in 3 weeks prior to study start

Outcomes

Primary Outcomes

Mean Change From Baseline in Daytime Nasal Symptoms Score Over 2 Weeks

Mean change from baseline in Daytime Nasal Symptoms score. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score. Scores were measured as 0 (best) to 3 (worst).

Time frame: Baseline and Week 2

Secondary Outcomes

Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks

Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale, and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score. Scores were measured as 0 (best) to 3 (worst).

Time frame: Baseline and Week 2

Mean Change From Baseline in Daytime Eye Symptoms Score Over 2 Weeks

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. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score. Scores were measured as 0 (best) to 3 (worst).

Time frame: Baseline and Week 2

Patient's Global Evaluation of Allergic Rhinitis at Week 2

An evaluation by the patient, 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. Scores were measured as 0 (best) to 6 (worst).

Time frame: Week 2

Physician's Global Evaluation of Allergic Rhinitis at Week 2

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. Scores were measured as 0 (best) to 6 (worst).

Data from ClinicalTrials.gov

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