Budesonide for Emergency Treatment of Acute Wheezing in Children

NCT ID: NCT00733317

Last Updated: 2011-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-12-31

Brief 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.

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.

Conditions

Asthma; Acute Asthma

Keywords

Wheezing; Acute asthma; Children; Budesonide; Emergency room

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

0.5 mg/ml budesonide nebules

Intervention Type: DRUG

Children will receive 0.5 mg/ml budesonide nebules every 20 minutes for 3 times

2- 0.9% saline

Children will receive 2 ml of saline every 20 minutes for 3 times and will not give after 3 doses

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

Children will receive 2 ml of saline every 20 minutes for 3 times

Interventions

0.5 mg/ml budesonide nebules

Children will receive 0.5 mg/ml budesonide nebules every 20 minutes for 3 times

Intervention Type: DRUG

Saline

Children will receive 2 ml of saline every 20 minutes for 3 times

Intervention Type: DRUG

Other Intervention Names

Budesonide 0.5 mg/ml nebules; 0.9% Saline solution

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kecioren Education and Training Hospital

OTHER

Sponsor Role: lead

Responsible Party

Cem Hasan Razi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

C H Razi, MD

Role: STUDY_DIRECTOR

Kecioren Education and Training Hospital

C H Razi, MD

Role: PRINCIPAL_INVESTIGATOR

Kecioren Education and Training Hospital

Locations

Kecioren Education and Training Hospital

Ankara, Kecioren, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

B.10.0.İEG.0.11.00.01- 1864

Identifier Type: -

Identifier Source: org_study_id