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

Seasonal Allergic Rhinitis Clinical Trial

Official title:

A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effect of Combination Montelukast/Loratadine in Patients With Seasonal Allergic Rhinitis-Fall Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00963599
• Other study ID #: 0476A-117
• Secondary ID: MK0476A-1172009_
• Status: Completed
• Phase: Phase 3
• Start date: September 1999
• Est. completion date: November 1999

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 907
• Est. completion date: November 1999
• Est. primary completion date: November 1999
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• Comparator: montelukast/loratadine
montelukast 10 mg/loratadine 10 mg tablet taken once daily at bed time for 2 weeks
• Comparator: montelukast
montelukast 10 mg tablet taken once daily at bed time for 2 weeks
• Comparator: loratadine
loratadine 10 mg tablet taken once daily at bed time for 2 weeks
• Comparator: placebo
placebo tablet taken once daily at bed time for 2 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

Nayak AS, Philip G, Lu S, Malice MP, Reiss TF; Montelukast Fall Rhinitis Investigator Group. Efficacy and tolerability of montelukast alone or in combination with loratadine in seasonal allergic rhinitis: a multicenter, randomized, double-blind, placebo-c — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in Daytime Nasal Symptoms Score	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.	Baseline and Week 2
Secondary	Mean Change From Baseline in Nighttime Symptoms Score	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.	Baseline and Week 2
Secondary	Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms)	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)).	Baseline and Week 2
Secondary	Mean Change From Baseline in Daytime Eye Symptoms Score	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.	Baseline and Week 2
Secondary	Mean Change From Baseline in Daytime Nasal Congestion Score	Patients were asked to rate the nasal symptom of Congestion daily on a 4-point scale (0 (best) to 3 (worst)).	Baseline and Week 2
Secondary	Mean Change From Baseline in Daytime Rhinorrhea Score	Patients were asked to rate the nasal symptom of Rhinorrhea daily on a 4-point scale (0 (best) to 3 (worst)).	Baseline and Week 2
Secondary	Mean Change From Baseline in Daytime Nasal Itching Score	Patients were asked to rate the nasal symptom of Nasal Itching daily on a 4-point scale (0 (best) to 3 (worst)).	Baseline and Week 2
Secondary	Mean Change From Baseline in Daytime Sneezing Score	Patients were asked to rate the nasal symptom of Sneezing daily on a 4-point scale (0 (best) to 3 (worst)).	Baseline and Week 2
Secondary	Mean Change From Baseline in Nasal Congestion Upon Awakening	Patients were asked to rate the symptom of Nasal Congestion Upon Awakening daily on a 4-point scale (0 (best) to 3 (worst)).	Baseline and Week 2
Secondary	Patient's Global Evaluation of Allergic Rhinitis	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).	Week 2
Secondary	Physician's Global Evaluation of Allergic Rhinitis	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).	Week 2
Secondary	Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score	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.	Week 2