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

Organon

Status and phase: Completed; Phase 3

Conditions: Rhinitis, Allergic, Perennial

Treatments: Drug: Comparator: Placebo; Drug: Montelukast

Study type: Interventional

Funder types: Industry

Identifiers

NCT00092118

0476-265

2004_018

MK0476-265

Details and patient eligibility

About

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.

Enrollment: 1,992 patients

Sex: All

Ages: 15 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,992 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Montelukast

Treatment:

Drug: Montelukast

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Comparator: Placebo