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Budesonide for Emergency Treatment of Acute Wheezing in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00733317
First Posted: August 13, 2008
Last Update Posted: December 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cem Hasan Razi, Kecioren Education and Training Hospital
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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:


Further study details as provided by Cem Hasan Razi, Kecioren Education and Training Hospital:

Primary Outcome Measures:
  • Pulmonary index score at 2 to 4 hours [ Time Frame: 2 to 4 hours ]

Secondary Outcome Measures:
  • Hospital admission rates [ Time Frame: 4 hours ]
  • Proportion of subjects improving from severe to moderate, severe to mild, and moderate to mild. [ Time Frame: 4 hours ]
  • Respiratory rate [ Time Frame: 2 hours ]
  • Oxygen saturation [ Time Frame: 2 hours ]
  • Time to discharge from the Emergency Department to home [ Time Frame: 2 to 4 hours ]
  • Adverse reactions. [ Time Frame: 2-5 days ]

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

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Ages Eligible for Study:   6 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: August 12, 2008
First Posted: August 13, 2008
Last Update Posted: December 20, 2011
Last Verified: December 2011

Keywords provided by Cem Hasan Razi, Kecioren Education and Training Hospital:
Wheezing
Acute asthma
Children
Budesonide
Emergency room

Additional relevant MeSH terms:
Asthma
Emergencies
Respiratory Sounds
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Disease Attributes
Pathologic Processes
Signs and Symptoms, Respiratory
Signs and Symptoms
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists