A Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis (MK-0476-192)(COMPLETED)

Seasonal Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00960141
• Other study ID #: 0476-192
• Secondary ID: MK0476-1922009_6
• Status: Completed
• Phase: Phase 3
• Start date: August 2000
• Est. completion date: November 2000

Study information

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

Clinical Trial Summary

A study of the ability of montelukast to improve signs and symptoms of seasonal allergic rhinitis compared with placebo. Loratadine is included in the study as an active control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 829
• Est. completion date: November 2000
• Est. primary completion date: October 2000
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patient has a documented clinical history of seasonal allergic rhinitis symptoms that become worse during the study season

• Patient is a non-smoker

• Patient is in good mental and physical health

Exclusion Criteria:

• Patient is hospitalized

• Patient is a woman who is <8 weeks postpartum or is breast feeding

• Patient intends to move or vacation away during the study

• Patient is a current or past abuser of alcohol or illicit drugs

Related Conditions & MeSH terms

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

Intervention

Drug:
• montelukast sodium
montelukast 10 mg tablet, taken orally once daily at bed time for 2 weeks
• Comparator: loratadine
loratadine 10 mg tablet, taken orally once daily at bed time for 2 weeks
• Comparator: placebo
placebo tablet, taken orally 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)

Chervinsky P, Philip G, Malice MP, Bardelas J, Nayak A, Marchal JL, van Adelsberg J, Bousquet J, Tozzi CA, Reiss TF. Montelukast for treating fall allergic rhinitis: effect of pollen exposure in 3 studies. Ann Allergy Asthma Immunol. 2004 Mar;92(3):367-73 — 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 on a 4-point scale [0(best) to 3(worst)]. The average of the 4 individual nasal symptoms scores (Congestion, Rhinorrhea, Itching, and Sneezing) 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 on a 4-point scale [0(best) to 3(worst)]. The average of 3 scores (Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings) was reported as the Nighttime Symptoms Score.	Baseline and Week 2
Secondary	Mean Change From Baseline in Daytime Eye Symptoms Score	Mean change from baseline in Daytime Eye Symptoms scores on a 4-point scale [0(best) to 3(worst)]. The average of the 4 individual eye symptoms scores (tearing, itchy, red, and puffy eyes) was reported as the Daytime Eye Symptoms Score.	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, in answer to a single question regarding 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 (or upon discontinuation)
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 validated, self-administered 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 scores for each domain were averaged, then the scores for the 7 domains were averaged for the overall score.	Baseline and Week 2