Montelukast in Patients With Seasonal Allergic Rhinitis - Spring 2000 Study (MK-0476A-162)(COMPLETED)

Seasonal Allergic Rhinitis Clinical Trial

Official title:

A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effects of Montelukast in Patients With Seasonal Allergic Rhinitis--Spring Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00979901
• Other study ID #: 0476A-162
• Secondary ID: MK0476A-1622009_
• Status: Completed
• Phase: Phase 3
• Start date: March 2000
• Est. completion date: May 2000

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 montelukast to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine and placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1577
• Est. completion date: May 2000
• Est. primary completion date: May 2000
• 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 and has been a nonsmoker for at least 1 year
• 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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Comparator: montelukast
10 mg montelukast tablet given once daily at bedtime for 2 weeks
• Comparator: loratadine
10 mg loratadine tablet given once daily at bedtime for 2 weeks
• Comparator: placebo
placebo tablet given once daily at bedtime for 2 weeks
• Comparator: montelukast/loratadine
montelukast 10-mg/loratadine 10-mg combination tablet taken orally once daily at bedtime for 2 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

Philip G, Malmstrom K, Hampel FC, Weinstein SF, LaForce CF, Ratner PH, Malice MP, Reiss TF; Montelukast Spring Rhinitis Study Group. Montelukast for treating seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled trial performed in the — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in Daytime Nasal Symptoms Score Over 2 Weeks	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. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal; Symptoms Score. Scores were measured as 0 (best) to 3 (worst).	Baseline and Week 2
Secondary	Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks	Mean change from baseline in Nighttime Symptoms Score.; Patients were asked to rate each symptom daily on a 4-point scale, and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score. Scores were measured as 0 (best) to 3 (worst).	Baseline and Week 2
Secondary	Mean Change From Baseline in Daytime Eye Symptoms Score Over 2 Weeks	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. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score. Scores were measured as 0 (best) to 3 (worst).	Baseline and Week 2
Secondary	Patient's Global Evaluation of Allergic Rhinitis at 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. Scores were measured as 0 (best) to 6 (worst).	Week 2
Secondary	Physician's Global Evaluation of Allergic Rhinitis at 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. Scores were measured as 0 (best) to 6 (worst).	Week 2
Secondary	Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score at Week 2	Patients completed the validated, self-administered RQLQ, which included 28 items on a 7-point scale across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Scores for each domain were averaged, then scores for the 7 domains were averaged for the overall score. Scores were measured as 0 (best) to 6 (worst).	Week 2