Nebulized Budesonide for Children Who Are Hospitalized for Acute Wheezing

Kecioren Education and Training Hospital

Status and phase: Completed; Phase 4

Conditions: Asthma; Acute Asthma

Treatments: Drug: % 0.9 Saline solution; Drug: Budesonide 0.5 mg/ml nebules

Study type: Interventional

Funder types: Other

Identifiers

NCT00733473

B.10.0.İEG.0.11.00.01-3246

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 6 months to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

1 Budesonide

Active Comparator group

Description:

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

Treatment:

Drug: Budesonide 0.5 mg/ml nebules

2 Placebo saline

Placebo Comparator group

Description:

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

Treatment:

Drug: % 0.9 Saline solution