An Approved Drug to Study a New Indication for Seasonal Allergic Rhinitis in Patients With Asthma (0476-269)

August 12, 2024 updated by: Organon and Co

A Multicenter, Double-Blind, Randomized Study Investigating the Clinical Effect of Montelukast on Allergic Rhinitis in Patients With Seasonal Allergic Rhinitis and Chronic Asthma

The purpose of this study is to determine the effect of an approved medication on the symptoms of seasonal allergic rhinitis (a seasonal variety of inflammation of the mucous membrane of the nose) in patients who are experiencing symptoms of seasonal allergic rhinitis and asthma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The duration of treatment is 2 weeks.

Study Type

Interventional

Enrollment (Actual)

831

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Non-smoker
  • A 2-year documented history of seasonal allergic rhinitis
  • A 1-year documented history of chronic asthma
  • Positive allergy testing

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Daily Rhinitis Symptoms score; the Daytime Nasal Symptoms score and Nighttime Symptoms score

Secondary Outcome Measures

Outcome Measure
(1) Rhinoconjunctivitis Quality-of-Life Questionnaire overall score; (2) Global Evaluation of Allergic Rhinitis by Patient; (3) Global Evaluation of Allergic Rhinitis by Physician

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Investigators

  • Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

October 1, 2003

Study Completion (Actual)

October 1, 2003

Study Registration Dates

First Submitted

September 23, 2004

First Submitted That Met QC Criteria

September 27, 2004

First Posted (Estimated)

September 28, 2004

Study Record Updates

Last Update Posted (Actual)

August 15, 2024

Last Update Submitted That Met QC Criteria

August 12, 2024

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0476-269
  • 2004_025

Plan for Individual participant data (IPD)

Study Data/Documents

  1. CSR Synopsis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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