NCT00189436

Brief Summary

Subjects aged 1-8 years who have been discharged from the emergency department/outpatient care facility with a diagnosis of asthma/bronchospasm/wheezing after usual standard care will be enrolled into this open-label, randomized, parallel-group study to compare the efficacy of nebulized budesonide and oral corticosteroids in preventing asthma exacerbation relapse rates during the 21-day follow-up period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for phase_4 asthma

Timeline
Completed

Started Mar 2003

Longer than P75 for phase_4 asthma

Geographic Reach
1 country

2 active sites

Status
completed

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

March 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

August 4, 2014

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

5.8 years

First QC Date

September 12, 2005

Results QC Date

July 8, 2014

Last Update Submit

January 8, 2021

Conditions

Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (1)

  • Wheezing/Asthma/Bronchospasm Relapse Rate

    This was defined as the percentage of subjects in each group (treatment with budesonide versus usual care) having an unscheduled acute visit to primary care, urgent care or an emergency department during the study period.

    3 weeks

Secondary Outcomes (2)

  • Urinary Cortisol Levels

    3 weeks

  • Forced Expiratory Volume in 1 Second (FEV1)

    3 weeks

Study Arms (2)

Treatment with Budesonide

ACTIVE COMPARATOR

Subject is treated with nebulized budesonide 0.5 BID for 3 weeks

Drug: Nebulized Budesonide

Usual care

ACTIVE COMPARATOR

Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid.

Drug: Usual care (albuterol with or without oral steroid)

Interventions

Nebulized BudesonideDRUG

Subject is treated with nebulized budesonide 0.5 BID for 3 weeks

Treatment with Budesonide
Usual care (albuterol with or without oral steroid)DRUG

Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)

Usual care

Eligibility Criteria

Age1 Year - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children ages 1-8 years old
  • Discharge from emergency department/outpatient clinic with a diagnosis of asthma exacerbation after usual standard care
  • Subjects must be able to show efficient use with a jet nebulizer

You may not qualify if:

  • Subjects requiring hospitalization
  • Subjects receiving oral steroids 1 week prior to presentation to emergency department.
  • Subjects with FEV1 \< 50% of predicted
  • Subjects with co-morbid medical conditions (renal or cardiovascular disease)
  • Subjects with reported history of HIV
  • Subjects unable to follow up for study visits
  • Subjects who are frequently enuretic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bellevue Pediatric Associates

Bellevue, Pennsylvania, 15202, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

AlbuterolSteroids

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylaminesFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
David Skoner, MD
Organization
Allegheny Singer Research Institute, WPAHS
dskoner@hsc.wvu.edu
412-359-4099

Study Officials

  • David Skoner, MD

    West Penn Allegheny Health System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Co-Investigator

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

March 1, 2003

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

February 1, 2021

Results First Posted

August 4, 2014

Record last verified: 2021-01

Locations

US(2)