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Completed

NCT Number: NCT00189436

Effect of Nebulized Budesonide and Oral Corticosteroids on Wheezing Episode Relapse in Children

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

1 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bellevue Pediatric Associates, Bellevue, Pennsylvania, United States

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About this study

Secondary outcomes include urinary cortisol-creatinine rations, symptom severity scores and peak flow rates.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Nebulized Budesonide

Drug

Subject is treated with nebulized budesonide 0.5 BID for 3 weeks

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)

Primary outcomes

  1. Wheezing/Asthma/Bronchospasm Relapse Rate

    Time frame: 3 weeks

    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.

Secondary outcomes

  1. Urinary Cortisol Levels

    Time frame: 3 weeks

    This was defined as the mean +/- standard deviation of 12 hour urinary cortisol levels in each group (treatment with budesonide versus usual care).

  2. Forced Expiratory Volume in 1 Second (FEV1)

    Time frame: 3 weeks

    This was defined as the mean +/- standard deviation of FEV1 in each group (treatment with budesonide versus usual care.

Sponsors and collaborators

Lead sponsor

Deborah Gentile

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

A Pilot Study to Evaluate the Effect of Nebulized Budesonide and Oral Corticosteroids on Wheezing Episode Relapse in Pediatric Patients Following Discharge From the Emergency Department/Outpatient Care Facility

Acronym: BudER

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Sep 19, 2005
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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