Montelukast Added to Standard Therapy for Acute Asthma in Children Age 6-14 Years

This study has been terminated.

( Results of the interim analysis suggested no significant diff between study groups. )

First Received on July 17, 2006. Last Updated on February 23, 2010 History of Changes

Sponsor:	Washington University School of Medicine
Collaborators:	American Academy of Pediatrics Ambulatory Pediatric Association
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00353184

Purpose

Oral montelukast is helpful in chronic asthma. The purpose of this pediatric study was to investigate whether the addition of oral montelukast to standard therapy for acute asthma exacerbations results in further improvement in breathing function over three hours.

Condition	Intervention
Asthma	Drug: Montelukast 5-mg orally added to standard therapy

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Randomized Controlled Trial of Oral Montelukast Added to Standard Therapy for Acute Asthma Exacerbations in Children Age 6 to 14 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 Washington University School of Medicine:

Primary Outcome Measures:

Forced Expiratory Volume in One Second (FEV1)

Secondary Outcome Measures:

Hospitalization Rate
Relapse Visit Rate

Enrollment:	27
Study Start Date:	September 2001
Study Completion Date:	February 2005
Primary Completion Date:	October 2004 (Final data collection date for primary outcome measure)

Detailed Description:

We hypothesized that children with moderate acute asthma exacerbations receiving oral montelukast in addition to standard therapy will have at least 12% greater FEV1 improvement in three hours than those receiving standard therapy alone.

In this randomized double-blind placebo-controlled study, we enrolled emergency patients aged 6-14 years with moderate acute asthma exacerbations (initial PEFR 40-70% predicted). Subjects received montelukast 5-mg or placebo orally then standard therapy consisting of weight-based doses of nebulized albuterol, nebulized ipratropium bromide, and oral corticosteroids. We measured FEV1 before study medication administration and hourly for three hours.

We conducted a planned an interim analysis after approximately one-half of the estimated sample had been enrolled.

Eligibility

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

Criteria

Inclusion Criteria:

Seeking care in ED for acute asthma exacerbation
Age 6-14 years inclusive
Initial FEV1 = 40-70% predicted (defined as moderate severity)
Consent to participate in study

Exclusion Criteria:

Severe exacerbation requiring immediate therapy as determined by treating clinician
Pregnancy by history
Cystic Fibrosis by history
Tuberculosis
Gastroesophageal reflux disease requiring medications
Acute or chronic liver disease
Bronchopulmonary dysplasia
Premature <34 weeks gestational age by history
Having used leukotriene-modifying medication within 48 hours
Having used theophylline within four weeks
Unable to perform FEV1

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353184

Locations

United States, Missouri
St. Louis Children's Hospital
St. Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

American Academy of Pediatrics

Ambulatory Pediatric Association

Investigators

Principal Investigator:	Kyle A Nelson, MD	Physician in Division of Pediatric Emergency Medicine at Washington University School of Medicine in St. Louis
Study Chair:	David M Jaffe, MD	Senior Advisor for Study, Division Director for Pediatric Emergency Medicine at Washington University School of Medicine

More Information

No publications provided

Responsible Party:	Kyle Nelson, Washington University
ClinicalTrials.gov Identifier:	NCT00353184 History of Changes
Other Study ID Numbers:	WUSM HSC #01-0464
Study First Received:	July 17, 2006
Last Updated:	February 23, 2010
Health Authority:	United States: Federal Government

Keywords provided by Washington University School of Medicine:

Acute
Asthma
Child
Pediatric
Emergency

Oral
Montelukast
Forced Expiratory Volume in One Second
FEV1

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 09, 2012