Nebulized Budesonide for Children Who Are Hospitalized for Acute Wheezing - Full Text View

Sponsor:	Kecioren Education and Training Hospital
Information provided by:	Kecioren Education and Training Hospital
ClinicalTrials.gov Identifier:	NCT00733473

Purpose

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.

Condition	Intervention	Phase
Asthma Acute Asthma	Drug: Budesonide 0.5 mg/ml nebules Drug: % 0.9 Saline solution	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Phase 4 Study of Nebulized Budesonide for Children Who Are Hospitalized for Acute Wheezing

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Budesonide

U.S. FDA Resources

Further study details as provided by Kecioren Education and Training Hospital:

Primary Outcome Measures:

Time to discharge from the hospital to home [ Time Frame: 1-5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pulmonary index score [ Time Frame: 1 to 5 days ] [ Designated as safety issue: No ]
Respiratory rate [ Time Frame: 1 to 5 days ] [ Designated as safety issue: No ]
Oxygen saturation [ Time Frame: 1 to 5 days ] [ Designated as safety issue: No ]
Adverse reactions. [ Time Frame: 1 to 5 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	80
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Children will receive 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
2: Placebo Comparator Children will receive 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

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.

Eligibility

Ages Eligible for Study:	6 Months to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733473

Contacts

Contact: C H Razi, MD

90 312 3569000 ext 2036

cemrazi2@superonline.com

Locations

Turkey, Kecioren
Kecioren Education and Training Hospital	Recruiting
Ankara, Kecioren, Turkey, 06380
Contact: C H Razi, MD 90 312 3569000 ext 2034 Cemrazi2@superonline.com
Contact: G Yılmaz, MD, PhD 90 312 3569000 ext 2034 gonca.yilmaz@tr.net
Principal Investigator: C H Razi, MD

Sponsors and Collaborators

Kecioren Education and Training Hospital

Investigators

Study Director:	C H Razi, MD	Kecioren Education and Training Hospital
Principal Investigator:	C H Razi, MD	Kecioren Education and Training Hospital

More Information

No publications provided

Responsible Party:	Kecioren Education and Training Hospital ( Kecioren Education and Training Hospital )
Study ID Numbers:	B.10.0.İEG.0.11.00.01-3246
Study First Received:	August 12, 2008
Last Updated:	September 3, 2009
ClinicalTrials.gov Identifier:	NCT00733473 History of Changes
Health Authority:	Turkey: Ethics Committee; Turkey: Ministry of Health

Keywords provided by Kecioren Education and Training Hospital:

Wheezing
Acute asthma
Children

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Anti-Asthmatic Agents
Asthma
Hormones
Glucocorticoids

Pharmacologic Actions
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010