Study of an Approved Drug in Patients With Asthma (0476-289)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092144
First received: September 21, 2004
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to assess the efficacy and safety of an approved drug on asthma symptoms in patients with chronic asthma which is also active during the allergy season.


Condition Intervention Phase
Asthma
Drug: MK0476, montelukast sodium / Duration of Treatment: 4 weeks
Drug: Comparator: placebo / Duration of Treatment: 4 weeks
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Evaluate the Clinical Effect of Oral MK0476 Vs Placebo During the Allergy Season in Patients With Seasonal Aeroallergen Sensitivity and Chronic Asthma Which is Also Active During Allergy Season

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To assess daytime asthma symptoms as measured by daily diaries over a 3-week treatment period

Secondary Outcome Measures:
  • To assess the following over a 3-week treatment period:
  • nighttime symptoms
  • AM PEFR
  • PM PEFR
  • B-agonist use
  • asthma attacks
  • discontinuations due to asthma

Estimated Enrollment: 500
Study Start Date: March 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Asthma symptoms brought on by allergies

Exclusion Criteria:

  • Patient has any lung disease
  • Currently have a sinus infection or cold symptoms
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092144

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

Publications:
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00092144     History of Changes
Other Study ID Numbers: 2004_028, MK0476-289
Study First Received: September 21, 2004
Last Updated: May 21, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
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 April 17, 2014