Budesonide for Emergency Treatment of Acute Wheezing in Children

Phase 4 Study of 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.

Study Overview

• Status: Completed
• Conditions: Asthma; Acute Asthma
• Intervention / Treatment: Drug: 0.5 mg/ml budesonide nebules; Drug: Saline

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Kecioren
    • Ankara, Kecioren, Turkey, 06380
      • Kecioren Education and Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1-Budesonide nebulized suspension; Children will receive 0.5 mg/ml budesonide nebules every 20 minutes for 3 times and will not give after 3 doses	Drug: 0.5 mg/ml budesonide nebules; Children will receive 0.5 mg/ml budesonide nebules every 20 minutes for 3 times; Other Names: Budesonide 0.5 mg/ml nebules
Placebo Comparator: 2- 0.9% saline; Children will receive 2 ml of saline every 20 minutes for 3 times and will not give after 3 doses	Drug: Saline; Children will receive 2 ml of saline every 20 minutes for 3 times; Other Names: 0.9% Saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pulmonary index score at 2 to 4 hours	2 to 4 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Hospital admission rates	4 hours
Proportion of subjects improving from severe to moderate, severe to mild, and moderate to mild.	4 hours
Respiratory rate	2 hours
Oxygen saturation	2 hours
Time to discharge from the Emergency Department to home	2 to 4 hours
Adverse reactions.	2-5 days

Collaborators and Investigators

• Sponsor: Kecioren Education and Training Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: August 12, 2008
• First Submitted That Met QC Criteria: August 12, 2008
• First Posted (Estimate): August 13, 2008

Study Record Updates

• Last Update Posted (Estimate): December 20, 2011
• Last Update Submitted That Met QC Criteria: December 17, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Children; Wheezing; Acute asthma; Budesonide; Emergency room
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Disease Attributes; Bronchial Diseases; Signs and Symptoms, Respiratory; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Emergencies; Asthma; Respiratory Sounds; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Budesonide
• Other Study ID Numbers: B.10.0.İEG.0.11.00.01- 1864