Nebulized Budesonide for Children Who Are Hospitalized for Acute Wheezing

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma; Acute Asthma
• Intervention / Treatment: Drug: Budesonide 0.5 mg/ml nebules; Drug: % 0.9 Saline solution

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.

• 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
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 1 Budesonide; This arm consist 50 children with recurrent wheezing who are hospitalized for wheezing epizode. They received 1 mg nebulized budesonide 2 times a day upto 5 days	Drug: Budesonide 0.5 mg/ml nebules; Children will receive 1 mg nebulized budesonide 2 times a day up to 5 days; Other Names: Pulmicort 0.5 mg/ml nebules
PLACEBO_COMPARATOR: 2 Placebo saline; This arm consist 50 children with recurrent wheezing who are hospitalized for wheezing epizode. They received 2ml of nebulized saline 2 times a day upto 5 days	Drug: % 0.9 Saline solution; Children will receive 2 ml of nebulized saline 2 times a day up to 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to discharge from the hospital to home	1-5 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Pulmonary index score	1 to 5 days
Respiratory rate	1 to 5 days
Oxygen saturation	1 to 5 days
Adverse reactions.	1 to 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): January 1, 2010

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
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Signs and Symptoms, Respiratory; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; 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.0.11.00.01-3246