Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246)

Organon and Co1,365 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,365

Conditions

Perennial Allergic Rhinitis

Interventions

montelukast sodiumDRUG

montelukast 10 mg tablet orally once daily at bedtime for 6 weeks

Comparator: cetirizineDRUG

cetirizine 10 mg tablet orally once daily at bedtime for 6 weeks

Comparator: placeboDRUG

placebo tablet orally once daily at bedtime for 6 weeks

Eligibility

Sex: ALLMin age: 15 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Baseline and first 4 weeks of a 6-week treatment period

Secondary Outcomes

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.

Time frame: Baseline and first 4 weeks in 6-week treatment period

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 \[Score 0 (best) to 3 (worst)\].

Time frame: Baseline and first 4 weeks in 6-week treatment period

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.

Time frame: End of the first 4 weeks in 6-week treatment period

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.

Data from ClinicalTrials.gov

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