Budesonide for Emergency Treatment of Acute Wheezing in Children - Full Text View

Sponsor:	Kecioren Education and Training Hospital
Information provided by (Responsible Party):	Cem Hasan Razi, Kecioren Education and Training Hospital
ClinicalTrials.gov Identifier:	NCT00733317

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 the emergency room.

Condition	Intervention	Phase
Asthma Acute Asthma	Drug: 0.5 mg/ml budesonide nebules Drug: Saline	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Phase 4 Study of Budesonide for Emergency Treatment of Acute Wheezing in Children

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:

Pulmonary index score at 2 to 4 hours [ Time Frame: 2 to 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hospital admission rates [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Proportion of subjects improving from severe to moderate, severe to mild, and moderate to mild. [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Respiratory rate [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Oxygen saturation [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Time to discharge from the Emergency Department to home [ Time Frame: 2 to 4 hours ] [ Designated as safety issue: No ]
Adverse reactions. [ Time Frame: 2-5 days ] [ Designated as safety issue: Yes ]

Enrollment:	100
Study Start Date:	September 2007
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 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	Drug: 0.5 mg/ml budesonide nebules Children will receive 0.5 mg/ml budesonide nebules every 20 minutes for 3 times Other Name: Budesonide 0.5 mg/ml nebules
Placebo Comparator: 2- 0.9% saline Children will receive 2 ml of saline every 20 minutes for 3 times and will not give after 3 doses	Drug: Saline Children will receive 2 ml of saline every 20 minutes for 3 times Other Name: 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 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.

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733317

Locations

Turkey
Kecioren Education and Training Hospital
Ankara, Kecioren, Turkey, 06380

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:	Cem Hasan Razi, MD, Kecioren Education and Training Hospital
ClinicalTrials.gov Identifier:	NCT00733317 History of Changes
Other Study ID Numbers:	B.10.0.İEG.0.11.00.01- 1864
Study First Received:	August 12, 2008
Last Updated:	December 17, 2011
Health Authority:	Turkey: Ethics Committee; Turkey: Ministry of Health

Keywords provided by Kecioren Education and Training Hospital:

Wheezing
Acute asthma
Children
Budesonide
Emergency room

Additional relevant MeSH terms:

Asthma
Emergencies
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Disease Attributes
Pathologic Processes
Budesonide

Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012