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An Approved Drug to Study a New Indication for Seasonal Allergic Rhinitis in Patients With Asthma

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00092885
First received: September 23, 2004
Last updated: January 21, 2010
Last verified: January 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Rhinitis, Allergic, Seasonal
Asthma, Bronchial
 Drug: MK0476, montelukast sodium
Drug: Comparator: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized Study Investigating the Clinical Effect of Montelukast on Allergic Rhinitis in Patients With Seasonal Allergic Rhinitis and Chronic Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma Hay Fever
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Daily Rhinitis Symptoms score; the Daytime Nasal Symptoms score and Nighttime Symptoms score

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

Estimated Enrollment: 800
Study Start Date: March 2003
Detailed Description:

The duration of treatment is 2 weeks.

  Eligibility

Ages Eligible for Study:   15 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092885

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Publications:

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00092885     History of Changes
Other Study ID Numbers: 2004_025, MK0476-269
Study First Received: September 23, 2004
Last Updated: January 21, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Rhinitis, Allergic, Seasonal
Rhinitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
 Otorhinolaryngologic Diseases
Respiratory Tract Infections
Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013