A Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis (MK-0476-192)(COMPLETED)

Phase 3

Completed

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

• Registration Number: NCT00960141
• Lead Sponsor: Organon and Co

Brief Summary

A study of the ability of montelukast to improve signs and symptoms of seasonal allergic rhinitis compared with placebo. Loratadine is included in the study as an active control.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-08
• Primary Completion: 2000-10
• Study Completion: 2000-11
• Study First Submitted: 2009-08-14
• Study First Submitted QC: 2009-08-14
• Study First Posted: 2009-08-17
• Results First Submitted: 2009-08-31
• Results First Submitted QC: 2010-05-17
• Results First Posted: 2010-06-09
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-01
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 829

Inclusion Criteria

• Patient has a documented clinical history of seasonal allergic rhinitis symptoms that become worse during the study season
• Patient is a non-smoker
• Patient is in good mental and physical health

Exclusion Criteria

• Patient is hospitalized
• Patient is a woman who is <8 weeks postpartum or is breast feeding
• Patient intends to move or vacation away during the study
• 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 Week 2	Mean change from baseline in Daytime Nasal Symptoms score on a 4-point scale \[0(best) to 3(worst)\]. The average of the 4 individual nasal symptoms scores (Congestion, Rhinorrhea, Itching, and Sneezing) was reported as the Daytime Nasal Symptoms Score.

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Nighttime Symptoms Score	Baseline and Week 2	Mean change from baseline in Nighttime Symptoms Score on a 4-point scale \[0(best) to 3(worst)\]. The average of 3 scores (Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings) was reported as the Nighttime Symptoms Score.
Mean Change From Baseline in Daytime Eye Symptoms Score	Baseline and Week 2	Mean change from baseline in Daytime Eye Symptoms scores on a 4-point scale \[0(best) to 3(worst)\]. The average of the 4 individual eye symptoms scores (tearing, itchy, red, and puffy eyes) was reported as the Daytime Eye Symptoms Score.
Patient's Global Evaluation of Allergic Rhinitis	Week 2 (or upon discontinuation)	An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale, in answer to a single question regarding the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).
Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score	Baseline and Week 2	Patients completed a validated, self-administered questionnaire, which included 28 questions on a 7-point scale \[score 0 (best) to 6 (worst)\] across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The scores for each domain were averaged, then the scores for the 7 domains were averaged for the overall score.
Physician's Global Evaluation of Allergic Rhinitis	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. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).