A Study to Evaluate MK0476 and Fluticasone to Control Asthma in Patients With Mild Persistent Asthma (0476-910)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00489346
First received: June 20, 2007
Last updated: June 22, 2015
Last verified: June 2015
  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 (Subject, Investigator)
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 ]

Enrollment: 994
Study Start Date: October 2001
Study Completion Date: June 2002
Primary Completion Date: June 2002 (Final data collection date for primary outcome measure)
  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
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: NCT00489346

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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00489346     History of Changes
Other Study ID Numbers: 0476-910, 2007_574
Study First Received: June 20, 2007
Last Updated: June 22, 2015
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

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

ClinicalTrials.gov processed this record on July 30, 2015