Montelukast Back to School Asthma Study - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00461032

Purpose

This study, in children with chronic asthma, evaluates the number of days of worsening asthma during 8 weeks of treatment with montelukast after treatment is started for the first day of school.

Condition	Intervention	Phase
Asthma	Drug: Comparator: montelukast Drug: Comparator: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double-blind, Placebo-Controlled Parallel Group 8-week Study to Evaluate the Efficacy and Safety of Chewable Montelukast When Initiated at the Start of the School Year in Pediatric Patients With Chronic Asthma

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:

Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Patients [ Time Frame: 8 Week treatment period initiated at the beginning of a school year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of Patients With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries) [ Time Frame: 8 Week treatment period initiated at the beginning of a school year ] [ Designated as safety issue: No ]
Percentage of Days With Increased β-agonist Use by >70% and a Minimum Increase of 2 Puffs From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Patients [ Time Frame: 8 Week treatment period initiated at the beginning of a school year ] [ Designated as safety issue: No ]
Percentage of Days With Increased Daytime Asthma Symptom Score by >50% From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Patients [ Time Frame: 8 Week treatment period initiated at the beginning of a school year ] [ Designated as safety issue: No ]

Enrollment:	1162
Study Start Date:	June 2006
Study Completion Date:	March 2007
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental montelukast	Drug: Comparator: montelukast montelukast 5 mg tablet QD for 8 weeks
2: Placebo Comparator Placebo	Drug: Comparator: Placebo Placebo to montelukast QD for 8 weeks

Eligibility

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

Criteria

Inclusion Criteria:

Male and female non-smoking patients, ages 6 to 14 years, with chronic asthma, history of at least one asthma exacerbation associated with a cold within the past year and a documented history of asthma that required treatment with any asthma medication within 6 months prior to Visit 1

Exclusion Criteria:

Patient cannot have any other acute or chronic pulmonary disorder, or hospitalization for asthma more than three times within one year prior to signing informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461032

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

PhRMA Clinical Study Results Database - web-based repository for clinical study results This link exits the ClinicalTrials.gov site

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

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_539, MK0476-340
Study First Received:	April 13, 2007
Results First Received:	January 12, 2010
Last Updated:	January 12, 2010
ClinicalTrials.gov Identifier:	NCT00461032 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Asthma
Pharmacologic Actions

Leukotriene Antagonists
Montelukast
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Therapeutic Uses
Lung Diseases
Hypersensitivity, Immediate
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010