Montelukast in Seasonal Allergic Rhinitis: Fall 2001 Study (0476-240)

Phase 3

Completed

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

• Registration Number: NCT00963469
• Lead Sponsor: Organon and Co

Brief Summary

This is a study to evaluate the treatment effect of montelukast 10 mg taken in the morning, versus placebo, in patients with seasonal allergic rhinitis. Loratadine is included in the study as an active control.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-08
• Primary Completion: 2001-11
• Study Completion: 2001-11
• Study First Submitted: 2009-08-19
• Study First Submitted QC: 2009-08-20
• Study First Posted: 2009-08-21
• Results First Submitted: 2009-09-16
• Results First Submitted QC: 2010-05-12
• 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: 1079

Inclusion Criteria

• Patient has a history of seasonal allergic rhinitis that worsens during the study season
• Patient is a nonsmoker
• Patient is in good health physical and mental health

Exclusion Criteria

• Patient is hospitalized
• Patient is a woman who is < 8 weeks postpartum or is breastfeeding
• Patient plans to move or vacation away during the study
• Patient has had any major surgery with in past 4 weeks
• 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 First 2 Weeks of Treatment Period	Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)	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 \[Score 0 (best) to 3 (worse)\]. 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 After First 2 Weeks of Treatment	After first 2 weeks of treatment	An evaluation by the patient, administered after the first 2 weeks of treatment 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 Nighttime Symptoms Score Over First 2 Weeks of Treatment Period	Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)	Mean change from baseline in Nighttime Symptoms Score.; Patients were asked to rate each symptom daily on a 4-point scale \[Score 0 (best) to 3 (worse)\], and the combined score of 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 Over First 2 Weeks of Treatment Period	Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)	Mean change from baseline in Daytime Eye Symptoms scores.; Patients were asked to rate each of the 4 eye symptom of tearing, itchy, red, and puffy eyes daily on a 4-point scale \[Score 0 (best) to 3 (worst)\]. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score.
Mean Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period	Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)	Composite Symptoms Scores were computed as the average of Daytime Nasal Scores \[Score 0 (best) to 3 (worst)\] and Nighttime Symptoms Scores \[Score 0 (best) to 3 (worst)\].
Physician's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment	After first 2 weeks of treatment	An evaluation by the physician, administered after the first 2 weeks of treatment 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 Rhinoconjunctivitis Quality-of-Life Score After First 2 Weeks of Treatment Period	Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)	Patients completed a Rhinoconjunctivitis Quality-of-Life Questionnaire-28 questions on a 7-point scale \[0(best) to 6(worst)\] across 7 domains: activity,sleep,non-nose/eye symptoms,practical problems,nasal symptoms, eye symptoms, and emotions. The scores for each domain were averaged, then scores for the 7 domains were averaged for an overall score.