NCT00353184

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Sep 2001

Typical duration for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2006

Completed
Last Updated

February 24, 2010

Status Verified

February 1, 2010

Enrollment Period

3.1 years

First QC Date

July 17, 2006

Last Update Submit

February 23, 2010

Conditions

Asthma

Keywords

AcuteAsthmaChildPediatricEmergencyOralMontelukastForced Expiratory Volume in One SecondFEV1

Outcome Measures

Primary Outcomes (1)

  • Forced Expiratory Volume in One Second (FEV1)

Secondary Outcomes (2)

  • Hospitalization Rate

  • Relapse Visit Rate

Interventions

Montelukast 5-mg orally added to standard therapyDRUG

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

AsthmaEmergencies

Interventions

montelukast

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kyle A Nelson, MD

    Physician in Division of Pediatric Emergency Medicine at Washington University School of Medicine in St. Louis

    PRINCIPAL INVESTIGATOR

  • David M Jaffe, MD

    Senior Advisor for Study, Division Director for Pediatric Emergency Medicine at Washington University School of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 17, 2006

First Posted

July 18, 2006

Study Start

September 1, 2001

Primary Completion

October 1, 2004

Study Completion

February 1, 2005

Last Updated

February 24, 2010

Record last verified: 2010-02

Locations

US(1)