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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00733473
Other study ID # B.10.0.IEG.0.11.00.01-3246
Secondary ID
Status Completed
Phase Phase 4
First received August 12, 2008
Last updated December 17, 2011
Start date September 2007
Est. completion date January 2010

Study information

Verified date December 2011
Source Kecioren Education and Training Hospital
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics CommitteeTurkey: Ministry of Health
Study type Interventional

Clinical Trial 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 children who have hospitalized for acute wheezing.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date January 2010
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 6 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Budesonide 0.5 mg/ml nebules
Children will receive 1 mg nebulized budesonide 2 times a day up to 5 days
% 0.9 Saline solution
Children will receive 2 ml of nebulized saline 2 times a day up to 5 days

Locations

Country Name City State
Turkey Kecioren Education and Training Hospital Ankara Kecioren

Sponsors (1)

Lead Sponsor Collaborator
Kecioren Education and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to discharge from the hospital to home 1-5 days No
Secondary Pulmonary index score 1 to 5 days No
Secondary Respiratory rate 1 to 5 days No
Secondary Oxygen saturation 1 to 5 days No
Secondary Adverse reactions. 1 to 5 days Yes
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