Nebulized Budesonide for Children Who Are Hospitalized for Acute Wheezing

Asthma Clinical Trial

Official title:

Phase 4 Study of Nebulized Budesonide for Children Who Are Hospitalized for Acute Wheezing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00733473
• Other study ID #: B.10.0.IEG.0.11.00.01-3246
• Status: Completed
• Phase: Phase 4
• First received: August 12, 2008
• Last updated: December 17, 2011
• Start date: September 2007
• Est. completion date: January 2010

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 children who have hospitalized for acute wheezing.

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 hospitalized children has any benefit on, symptom score, duration of hospitalization and time to discharge from hospital.

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 hospital 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, duration of hospitalization and time to discharge from hospital will be compared between treatment groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2010
• 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

• Children who admitted to the hospital for acute wheezing

• Clinical asthma score of 3-9

• 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

Intervention

Drug:
• Budesonide 0.5 mg/ml nebules
Children will receive 1 mg nebulized budesonide 2 times a day up to 5 days
• % 0.9 Saline solution
Children will receive 2 ml of nebulized saline 2 times a day up to 5 days

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	Time to discharge from the hospital to home		1-5 days	No
Secondary	Pulmonary index score		1 to 5 days	No
Secondary	Respiratory rate		1 to 5 days	No
Secondary	Oxygen saturation		1 to 5 days	No
Secondary	Adverse reactions.		1 to 5 days	Yes