Montelukast in Seasonal Allergic Rhinitis - Spring 2001 Study (0476-235)

Phase 3

Completed

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

• Registration Number: NCT00972738
• Lead Sponsor: Organon and Co

Brief Summary

This study will assess the treatment effect of montelukast versus placebo over a 2 week period in patients with seasonal allergic rhinitis. Loratadine is included in the study as an active comparator.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-04
• Primary Completion: 2001-07
• Study Completion: 2001-07
• Study First Submitted: 2009-09-04
• Study First Submitted QC: 2009-09-04
• Study First Posted: 2009-09-07
• Results First Submitted: 2009-09-15
• Results First Submitted QC: 2010-05-14
• Results First Posted: 2010-06-16
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-01
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1214

Inclusion Criteria

• Patient has a documented history of season allergic rhinitis symptoms that flare up during the study season
• 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 has had major surgery in the past 4 weeks
• 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 Over the 2-week Treatment Period	Baseline and over the 2-week treatment period	Mean change from baseline in Daytime Nasal Symptoms. Patients were asked to rate each of the 4 nasal symptoms 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
Patient's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period	End of the 2-week treatment period	An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale \[Score 0 (very much better) to 6 (very much worse)\], of the change in symptoms as compared to the beginning of the study.
Physician's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period	End of the 2-week treatment period	An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale \[Score 0 (very much better) to 6 (very much worse)\], of the change in symptoms as compared to the beginning of the study.
Mean Change From Baseline in Nighttime Symptoms Score Over the 2-week Treatment Period	Baseline and over the 2-week treatment period	Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptoms of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings daily on a 4-point \[Scale 0 (best) to 3 (worst)\]. The average of the individual symptoms scores was reported as the Nighttime Symptoms Score.
Mean Change From Baseline in Daytime Eye Symptoms Score Over the 2-week Treatment Period	Baseline and over the 2-week treatment period	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 \[0 (best) to 3 (worst)\]. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score.
Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After the 2-week Treatment Period	Baseline and at the end of 2-week treatment period	Patients completed a validated, self-administered Rhinoconjunctivitis Quality-of-Life 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 individual domain scores were calculated as the average values of all scores within a domain, then the scores for the 7 domains were averaged for the overall score.