A Study to Evaluate MK0476 and Fluticasone to Control Asthma in Patients With Mild Persistent Asthma

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00489346
First received: June 20, 2007
Last updated: September 23, 2009
Last verified: September 2009
  Purpose

A study to evaluate MK0476 and Fluticasone to control asthma in patients with mild persistent asthma.


Condition Intervention Phase
Asthma, Bronchial
Drug: MK0476, montelukast sodium / Duration of Treatment: 1 Year
Drug: Comparator : fluticasone propionate / Duration of Treatment: 1 Year
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Double-Dummy, Multicenter Study to Evaluate and Compare Oral Montelukast and Inhaled Fluticasone in the Control of Asthma for 6- to 14-Year-Olds With Mild Persistent Asthma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Improvement of asthma with MK0476 and Fluticasone as measured by number of asthma rescue-free days [ Time Frame: Duration of Trial ]

Secondary Outcome Measures:
  • Improved effect of MK0476 and fluticasone on FEV1 values [ Time Frame: Duration of Trial ]

Estimated Enrollment: 1000
Study Start Date: July 2001
Study Completion Date: June 2003
  Eligibility

Ages Eligible for Study:   6 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is male or female, 6-14 years of age with mild persistent asthma
  • Patient has a history of the following symptoms: wheezing, chest tightness, cough, etc.
  • Patient has asthma diagnosed by a doctor

Exclusion Criteria:

  • Patient is hospitalized
  • Patient has had major surgery or participated in another clinical trial in the last 4 weeks
  • Patient has been on a breathing tube for asthma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489346

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

Publications:
ClinicalTrials.gov Identifier: NCT00489346     History of Changes
Other Study ID Numbers: 2007_574
Study First Received: June 20, 2007
Last Updated: September 23, 2009
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Montelukast
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on April 23, 2014