Budesonide for Emergency Treatment of Acute Wheezing in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cem Hasan Razi, Kecioren Education and Training Hospital
ClinicalTrials.gov Identifier:
NCT00733317
First received: August 12, 2008
Last updated: December 17, 2011
Last verified: December 2011
  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
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014