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Budesonide for Emergency Treatment of Acute Wheezing in Children

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ClinicalTrials.gov Identifier: NCT00733317
Recruitment Status : Completed
First Posted : August 13, 2008
Last Update Posted : December 20, 2011
Sponsor:
Information provided by (Responsible Party):
Cem Hasan Razi, Kecioren Education and Training Hospital

August 12, 2008
August 13, 2008
December 20, 2011
September 2007
December 2009   (Final data collection date for primary outcome measure)
Pulmonary index score at 2 to 4 hours [ Time Frame: 2 to 4 hours ]
Same as current
Complete list of historical versions of study NCT00733317 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Budesonide for Emergency Treatment of Acute Wheezing in Children
Phase 4 Study of Budesonide for Emergency Treatment of Acute Wheezing in Children
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Asthma
  • Acute Asthma
  • 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
  • Drug: Saline
    Children will receive 2 ml of saline every 20 minutes for 3 times
    Other Name: 0.9% Saline solution
  • 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
    Intervention: Drug: 0.5 mg/ml budesonide 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
    Intervention: Drug: Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
80
December 2009
December 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Months to 6 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
 
NCT00733317
B.10.0.İEG.0.11.00.01- 1864
No
Not Provided
Not Provided
Cem Hasan Razi, Kecioren Education and Training Hospital
Kecioren Education and Training Hospital
Not Provided
Study Director: C H Razi, MD Kecioren Education and Training Hospital
Principal Investigator: C H Razi, MD Kecioren Education and Training Hospital
Kecioren Education and Training Hospital
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP