Budesonide for Emergency Treatment of Acute Wheezing in Children

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00733317
• Other study ID #: B.10.0.IEG.0.11.00.01- 1864
• Status: Completed
• Phase: Phase 4
• First received: August 12, 2008
• Last updated: December 17, 2011
• Start date: September 2007
• Est. completion date: December 2009

Study information

• Verified date: December 2011
• Source: Kecioren Education and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics CommitteeTurkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 6 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Asthma
• Asthma
• Emergencies

Intervention

Drug:
• 0.5 mg/ml budesonide nebules
Children will receive 0.5 mg/ml budesonide nebules every 20 minutes for 3 times
• Saline
Children will receive 2 ml of saline every 20 minutes for 3 times

Locations

Country	Name	City	State
Turkey	Kecioren Education and Training Hospital	Ankara	Kecioren

Sponsors (1)

Lead Sponsor	Collaborator
Kecioren Education and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary index score at 2 to 4 hours		2 to 4 hours	No
Secondary	Hospital admission rates		4 hours	No
Secondary	Proportion of subjects improving from severe to moderate, severe to mild, and moderate to mild.		4 hours	No
Secondary	Respiratory rate		2 hours	No
Secondary	Oxygen saturation		2 hours	No
Secondary	Time to discharge from the Emergency Department to home		2 to 4 hours	No
Secondary	Adverse reactions.		2-5 days	Yes