Skip to main content
OpenTrials
Completed

NCT Number: NCT00733317

Budesonide for Emergency Treatment of Acute Wheezing in Children

The purpose of this study is to determine if adding nebulized budesonide to the systemic steroid for treatment of acute wheezing has any additive benefit in the emergency room.

Completed

Looking for future studies?

Notify Me

Key information

About this study

Context: Inhaled steroids reduced admission rates in patients with acute asthma, but it is unclear if there is a benefit of inhaled corticosteroids when used in addition to systemic corticosteroids. There is insufficient evidence that inhaled corticosteroids result in clinically important changes in pulmonary function or clinical scores when used in acute asthma. Similarly, it was mentioned in the Cochrane Database of Systematic Reviews that further research is needed to clarify if there is a benefit of inhaled corticosteroids when used in addition to systemic steroids.

Objective: To determine if adding nebulized budesonide to the systemic steroid for treatment of acute wheezing in the emergency room has any benefit on, symptom score, hospitalization rate and time to discharge from emergency room.

Study Design/Setting/Participants: A double-blind, randomized, controlled trial of nebulized budesonide versus placebo for children 6 months to 6 years of age who have admitted to the emergency room for acute wheezing.

Intervention: Participants will receive standard therapy including SCS, albuterol, and ipratropium bromide and will be randomly assigned to also receive either nebulized BIS or saline.

Study Measures: Differences in asthma scores, vital signs, and the need for hospitalization will be compared between treatment groups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children who have recurrent wheezing attacks and admitted to the emergency room for acute wheezing
  • Pulmonary index score of 7-13
  • Parental/guardian permission (informed consent) and if appropriate, child assent

Exclusion criteria

  • Systemic corticosteroid use in the last 30 days
  • Chronic lung diseases including cystic fibrosis
  • Immunodeficiency
  • Cardiac disease requiring surgery or medications
  • Adverse drug reaction or allergy to budesonide, albuterol, ipratropium bromide, prednisone, prednisolone, or methylprednisolone
  • Known renal or hepatic dysfunction
  • Impending respiratory failure requiring positive pressure ventilation
  • Immune deficiency
  • Gastroesophageal reflux disease
  • Suspected foreign body aspiration or croup
  • Anatomic abnormalities of the respiratory tract

Treatment and study plan

0.5 mg/ml budesonide nebules

Drug

Children will receive 0.5 mg/ml budesonide nebules every 20 minutes for 3 times

Other names: Budesonide 0.5 mg/ml nebules

Saline

Drug

Children will receive 2 ml of saline every 20 minutes for 3 times

Other names: 0.9% Saline solution

Primary outcomes

  1. Pulmonary index score at 2 to 4 hours

    Time frame: 2 to 4 hours

Secondary outcomes

  1. Hospital admission rates

    Time frame: 4 hours

  2. Proportion of subjects improving from severe to moderate, severe to mild, and moderate to mild.

    Time frame: 4 hours

  3. Respiratory rate

    Time frame: 2 hours

  4. Oxygen saturation

    Time frame: 2 hours

  5. Time to discharge from the Emergency Department to home

    Time frame: 2 to 4 hours

  6. Adverse reactions.

    Time frame: 2-5 days

Sponsors and collaborators

Lead sponsor

Kecioren Education and Training Hospital

Other

Registry information

Official study title

Phase 4 Study of Budesonide for Emergency Treatment of Acute Wheezing in Children

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Aug 13, 2008
Registry last updated
Dec 20, 2011

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.

Published trials that share one or more normalized conditions with this study.