A Study of MK0476 in the Treatment of Asthma Patients Aged 2-5 Years - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00700661

Purpose

A study to determine the efficacy of MK0476 in the Treatment of Asthmatic Patients Aged 2 to 5 Years.

Condition	Intervention	Phase
Asthma	Drug: montelukast Drug: placebo (unspecified)	Phase III

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 Determine the Efficacy of Montelukast in the Treatment of Exacerbations in Asthmatic Patients Aged 2-to-5 Years

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

asthma episodes in 2 - 5 year old children [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

the number of treatments and duration of asthma episodes [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Enrollment:	500
Primary Completion Date:	December 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Drug	Drug: montelukast One montelukast 4-mg chewable tablet (CT) administered once daily at bedtime. Duration of Treatment: 48 Weeks Other Names: MK0476 SINGULAIR ®
Placebo Comparator: 2 Pbo	Drug: placebo (unspecified) Matching-image Montelukast placebo. Duration of Treatment: 48 Weeks

Eligibility

Ages Eligible for Study:	2 Years to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or Female between and including the ages of 2 and 5 years
Patient was treated with steroids for an asthma episode in the last 3 months
Patient was admitted to the hospital or emergency room in the last 3 months
Patient is able to chew a tablet

Exclusion Criteria:

Patient has been in a research study in the past 4 weeks
Patient has visited the emergency room for an asthma episode in the past week
Patients has a history of stomach, heart, liver, nerve, kidney or blood disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700661

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

Publications:

Bisgaard H, Zielen S, Garcia-Garcia ML, Johnston SL, Gilles L, Menten J, Tozzi CA, Polos P. Montelukast reduces asthma exacerbations in 2- to 5-year-old children with intermittent asthma. Am J Respir Crit Care Med. 2005 Feb 15;171(4):315-22. Epub 2004 Nov 12.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00700661 History of Changes
Other Study ID Numbers:	2007_572, MK0476-907
Study First Received:	June 17, 2008
Last Updated:	September 23, 2009
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

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 February 12, 2012