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

Sponsor:	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

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

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:

Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration [ Time Frame: Baseline and (time weighted average over) 60 Minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change From Baseline in Modified Pulmonary Index [mPI] Score [ Time Frame: Baseline and 60 minutes ] [ Designated as safety issue: No ]
Number of Participants With Treatment Failure (Hospitalization or Time to Decision to Discharge > 2 Hours) [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
Time-Weighted Average Change in FEV1 Over 45 Minutes Following the End of Study Drug Administration [ Time Frame: Baseline and (time-weighed average over) 45 Minutes ] [ Designated as safety issue: No ]
Time-Weighted Average Change in FEV1 Over 30 Minutes Following the End of Study Drug Administration [ Time Frame: Baseline and (time-weighted average over) 30 Minutes ] [ Designated as safety issue: No ]
Change in FEV1 After 15 Minutes Following the End of Study Drug Administration [ Time Frame: Baseline and 15 Minutes ] [ Designated as safety issue: No ]
Total Dose of β-agonist Administered Per Patient Over a Period of 2 Hours Following the End of Study Drug Administration [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]

Enrollment:	276
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

No publications provided

Responsible Party:	Merck Sharp & Dohme Corp ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_026, MK0476-301
Study First Received:	June 30, 2005
Results First Received:	March 16, 2009
Last Updated:	January 27, 2010
ClinicalTrials.gov Identifier:	NCT00117338 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