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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: June 20, 2007
Last updated: March 3, 2017
Last verified: March 2017
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)

Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00489346

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

Study Data/Documents: CSR Synopsis  This link exits the site

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00489346     History of Changes
Other Study ID Numbers: 0476-910
Study First Received: June 20, 2007
Last Updated: March 3, 2017

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action processed this record on August 17, 2017