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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00489346
Recruitment Status : Completed
First Posted : June 21, 2007
Last Update Posted : March 6, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 994 participants
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
Study Start Date : October 2001
Actual Primary Completion Date : June 2002
Actual Study Completion Date : June 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00489346

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

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
First Posted: June 21, 2007    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: March 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