Nebulized Budesonide for Children Who Are Hospitalized for Acute Wheezing

Condition(s) targeted: Asthma; Acute Asthma

Intervention: Budesonide 0.5 mg/ml nebules (Drug); % 0.9 Saline solution (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Kecioren Education and Training Hospital

Official(s) and/or principal investigator(s):
C H Razi, MD, Study Director, Affiliation: Kecioren Education and Training Hospital
C H Razi, MD, Principal Investigator, Affiliation: Kecioren Education and Training Hospital

Overall contact:
C H Razi, MD, Phone: 90 312 3569000, Ext: 2036, Email: cemrazi2@superonline.com

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Primary outcome: Time to discharge from the hospital to home

Secondary outcome:

Pulmonary index score

Respiratory rate

Oxygen saturation

Adverse reactions.

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 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.

Minimum age: 6 Months. Maximum age: 6 Years. Gender(s): Both.

Criteria:

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

C H Razi, MD, Phone: 90 312 3569000, Ext: 2036, Email: cemrazi2@superonline.com

Kecioren Education and Training Hospital, Ankara, Kecioren 06380, Turkey; Recruiting
C H Razi, MD, Phone: 90 312 3569000, Ext: 2034, Email: Cemrazi2@superonline.com
G Yılmaz, MD, PhD, Phone: 90 312 3569000, Ext: 2034, Email: gonca.yilmaz@tr.net
C H Razi, MD, Principal Investigator

Starting date: September 2007
Ending date: December 2009
Last updated: September 3, 2009