Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117)

Phase 3

Completed

• Conditions: Seasonal Allergic Rhinitis

• Registration Number: NCT00963599
• Lead Sponsor: Organon and Co

Brief Summary

This study will evaluate the ability of oral montelukast/loratadine to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine alone, montelukast alone and placebo.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-09
• Primary Completion: 1999-11
• Study Completion: 1999-11
• Study First Submitted: 2009-08-19
• Study First Submitted QC: 2009-08-20
• Study First Posted: 2009-08-21
• Results First Submitted: 2009-08-31
• Results First Submitted QC: 2010-05-14
• Results First Posted: 2010-06-16
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 907

Inclusion Criteria

• Patient has a documented history of seasonal 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 less than 8 weeks postpartum or is breast-feeding
• Patient intends to move or vacation away during the study
• Patient has had any major surgery within 4 weeks of study start
• Patient is a current or past abuser of alcohol or illicit drugs
• Patient has been treated in an emergency room for asthma in the past month
• Patient had an upper respiratory infection with in 3 weeks prior to study start
• Patient has any active pulmonary disorder other than asthma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale (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 Week 2	Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale (0 (best) to 3 (worst)), and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score.
Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms)	Baseline and Week 2	Composite Symptoms scores were computed as the average of the Daytime Nasal Symptoms scores and Nighttime Symptoms scores collected on a 4 point scale (0 (best) to 3 (worst)).
Mean Change From Baseline in Daytime Nasal Congestion Score	Baseline and Week 2	Patients were asked to rate the nasal symptom of Congestion daily on a 4-point scale (0 (best) to 3 (worst)).
Mean Change From Baseline in Daytime Eye Symptoms Score	Baseline and 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 (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 Daytime Rhinorrhea Score	Baseline and Week 2	Patients were asked to rate the nasal symptom of Rhinorrhea daily on a 4-point scale (0 (best) to 3 (worst)).
Mean Change From Baseline in Daytime Nasal Itching Score	Baseline and Week 2	Patients were asked to rate the nasal symptom of Nasal Itching daily on a 4-point scale (0 (best) to 3 (worst)).
Mean Change From Baseline in Daytime Sneezing Score	Baseline and Week 2	Patients were asked to rate the nasal symptom of Sneezing daily on a 4-point scale (0 (best) to 3 (worst)).
Mean Change From Baseline in Nasal Congestion Upon Awakening	Baseline and Week 2	Patients were asked to rate the symptom of Nasal Congestion Upon Awakening daily on a 4-point scale (0 (best) to 3 (worst)).
Patient's Global Evaluation of Allergic Rhinitis	Week 2	An evaluation by the patient, 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).
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).
Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score	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: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, emotional. Scores per domain were averaged, then scores for the 7 domains were averaged for an overall score.