A Study of an Intravenous Drug in Pediatric Patients With Acute Asthma - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00117338

Purpose

This study will attempt to find out if the addition of an intravenous form of a drug that is already used for treating asthma in children, will help resolve asthma attacks faster than using the current standard care alone.

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

MedlinePlus related topics: Asthma

Drug Information available for: Sodium chloride Dextrose Montelukast sodium Montelukast Chlorides

U.S. FDA Resources

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 Study Comparing the Clinical Effects of Intravenous Montelukast With Placebo in Pediatric Patients (Ages 6 to 14 Years) With Acute Asthma

Further study details as provided by Merck:

Primary Outcome Measures:

Improvement in FEV1 over the first 60 minutes after administration [ Time Frame: 120 Minutes ] [ Designated as safety issue: No ]

Enrollment:	300
Study Start Date:	August 2005
Study Completion Date:	April 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo	Drug: Comparator: placebo (unspecified) Pbo for a study approximately 120 minutes in duration
2: Active Comparator montelukast sodium	Drug: montelukast sodium Montelukast IV 5.25 mg lyophilized (reconstituted in 20 mL of 3.3% dextrose/0.3% sodium chloride) for a study approximately 120 minutes in duration

Detailed Description:

The duration of treatment is a one time dose.

Eligibility

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

Criteria

Inclusion Criteria:

Children 6-14 years of age seeking treatment in emergency departments with acute asthma attacks

Exclusion Criteria:

Other respiratory conditions (including congenital lung abnormalities) or other acute illnesses that would complicate current treatment and response for asthma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117338

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_026, MK0476-301
Study First Received:	June 30, 2005
Last Updated:	May 9, 2008
ClinicalTrials.gov Identifier:	NCT00117338
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Montelukast
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Asthma
Leukotriene Antagonists
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents
Immune System Diseases
Bronchial Diseases
Therapeutic Uses
Hormone Antagonists

Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009