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

February 23, 2010 updated by: Washington University School of Medicine

Randomized Controlled Trial of Oral Montelukast Added to Standard Therapy for Acute Asthma Exacerbations in Children Age 6 to 14 Years

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Forced Expiratory Volume in One Second (FEV1)

Secondary Outcome Measures

Outcome Measure
Hospitalization Rate
Relapse Visit Rate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Primary Completion (Actual)

October 1, 2004

Study Completion (Actual)

February 1, 2005

Study Registration Dates

First Submitted

July 17, 2006

First Submitted That Met QC Criteria

July 17, 2006

First Posted (Estimate)

July 18, 2006

Study Record Updates

Last Update Posted (Estimate)

February 24, 2010

Last Update Submitted That Met QC Criteria

February 23, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WUSM HSC #01-0464

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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