The Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis (0476-265)

NCT ID: NCT00092118

Last Updated: 2022-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1992 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2004-05-31

Brief Summary

The purpose of this study is to determine the effect of an approved medication on the symptoms of perennial allergic rhinitis (an inflammation of the mucous membrane of the nose similar to that found in hay fever except that symptoms persist throughout the year), in patients who have a history of perennial allergic rhinitis.

Conditions

Rhinitis, Allergic, Perennial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Montelukast

Group Type: EXPERIMENTAL

Montelukast

Intervention Type: DRUG

one 10 mg tablet, taken once daily at bed time for 6 weeks

2

Placebo

Group Type: PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type: DRUG

one placebo tablet, taken once daily at bed time for 6 weeks

Interventions

Montelukast

one 10 mg tablet, taken once daily at bed time for 6 weeks

Intervention Type: DRUG

Comparator: Placebo

one placebo tablet, taken once daily at bed time for 6 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Non-smoker with a 2-year documented history of perennial allergic (symptoms that persist throughout the year) rhinitis symptoms and positive allergy testing

Exclusion Criteria

• Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Patel P, Philip G, Yang W, Call R, Horak F, LaForce C, Gilles L, Garrett GC, Dass SB, Knorr BA, Reiss TF. Randomized, double-blind, placebo-controlled study of montelukast for treating perennial allergic rhinitis. Ann Allergy Asthma Immunol. 2005 Dec;95(6):551-7. doi: 10.1016/S1081-1206(10)61018-6.

Reference Type: BACKGROUND

PMID: 16400895 (View on PubMed)

Other Identifiers

MK0476-265

Identifier Type: -

Identifier Source: secondary_id

2004_018

Identifier Type: -

Identifier Source: secondary_id

0476-265

Identifier Type: -

Identifier Source: org_study_id