Clinical trial NCT00733317: Budesonide for Emergency Treatment of Acute Wheezing in Children
Official title: Phase 4 Study of Budesonide for Emergency Treatment of Acute Wheezing in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Acute Asthma
Keywords: Wheezing
Acute asthma
Children
Budesonide
Emergency room
Lead sponsor: Kecioren Education and Training Hospital
Sponsor class: OTHER
First posted: 2008-08-13
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pulmonary index score at 2 to 4 hours
timeFrame: 2 to 4 hours
Secondary outcomes:
measure: Hospital admission rates
timeFrame: 4 hours
measure: Proportion of subjects improving from severe to moderate, severe to mild, and moderate to mild.
timeFrame: 4 hours
measure: Respiratory rate
timeFrame: 2 hours
measure: Oxygen saturation
timeFrame: 2 hours
measure: Time to discharge from the Emergency Department to home
timeFrame: 2 to 4 hours
measure: Adverse reactions.
timeFrame: 2-5 days
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Kecioren Education and Training Hospital
state: Kecioren
Study officials:
affiliation: Kecioren Education and Training Hospital
name: C H Razi, MD
role: STUDY_DIRECTOR
affiliation: Kecioren Education and Training Hospital
name: C H Razi, MD
role: PRINCIPAL_INVESTIGATOR
References: