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

Phase 3

Completed

• Conditions: Perennial Allergic Rhinitis
• Interventions: Drug: montelukast sodium

• Registration Number: NCT00974571
• Lead Sponsor: Organon and Co

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-11
• Primary Completion: 2002-05
• Study Completion: 2002-05
• Study First Submitted: 2009-09-09
• Study First Submitted QC: 2009-09-09
• Study First Posted: 2009-09-10
• Results First Submitted: 2009-09-17
• Results First Submitted QC: 2010-05-07
• Results First Posted: 2010-06-07
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-01
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1365

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	montelukast sodium	montelukast

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Daytime Nasal Symptoms Score	Baseline and first 4 weeks of a 6-week 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 \[Score 0 (best) to 3 (worst)\]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Nighttime Symptoms Score	Baseline and first 4 weeks in 6-week treatment period	Mean change from baseline in Nighttime Symptoms Score.; Patients were asked to rate each symptom daily on a 4-point scale \[Score 0 (best) to 3 (worst)\], and the average score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score.
Physician's Global Evaluation of Allergic Rhinitis	End of the first 4 weeks in 6-week treatment period	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.
Mean Change From Baseline in Composite Symptoms Score	Baseline and first 4 weeks in 6-week treatment period	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	End of the first 4 weeks in 6-week treatment period	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.