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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092118
First received: September 21, 2004
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Rhinitis, Allergic, Perennial
Drug: Montelukast
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, Placebo-Controlled, Parallel-Group Study Investigating the Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Mean Change From Baseline in Daytime Nasal Symptoms Score Averaged Over the 6-week Treatment Period in Patients With Perennial Allergic Rhinitis [ Time Frame: 6 week treatment period (from baseline though the end of week 6) ] [ Designated as safety issue: No ]
    Mean change from baseline in Daytime Nasal Symptoms score averaged over the 6-week treatment period. The Daytime Nasal Symptoms score was calculated as the average of the 3 individual scores for Congestion, Rhinorrhea, and Sneezing, each rated by patients daily on a 4-point scale [Score 0 (best) to 3 (worst)].


Secondary Outcome Measures:
  • Patient's Global Evaluation of Allergic Rhinitis at the End of the 6 Week Treatment Period [ Time Frame: At the end of the 6 week treatment period ] [ Designated as safety issue: No ]
    An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], in answer to a single question regarding the change in symptoms as compared to the beginning of the study.

  • Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score After the 6 Week Treatment Period [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    Patients completed the validated, self-administered RQLQ which included 28 items on a 7-point scale [Score 0 (best) to 6 (worst)] across 7 domains: activities, sleep, nonnose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The scores for each domain were averaged, then scores for the 7 domains were averaged to obtain the overall score.


Enrollment: 1992
Study Start Date: October 2003
Study Completion Date: May 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Montelukast
Drug: Montelukast
one 10 mg tablet, taken once daily at bed time for 6 weeks
Placebo Comparator: 2
Placebo
Drug: Comparator: Placebo
one placebo tablet, taken once daily at bed time for 6 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092118

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092118     History of Changes
Other Study ID Numbers: 0476-265, MK0476-265, 2004_018
Study First Received: September 21, 2004
Results First Received: September 10, 2009
Last Updated: May 9, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 19, 2014