Nebulized Budesonide for Children Who Are Hospitalized for Acute Wheezing
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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 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 Nebulized Budesonide for Children Who Are Hospitalized for Acute Wheezing |
- Time to discharge from the hospital to home [ Time Frame: 1-5 days ] [ Designated as safety issue: No ]
- 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 ]
| Enrollment: | 100 |
| Study Start Date: | September 2007 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1 Budesonide
This arm consist 50 children with recurrent wheezing who are hospitalized for wheezing epizode. They received 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
Other Name: Pulmicort 0.5 mg/ml nebules
|
|
Placebo Comparator: 2 Placebo saline
This arm consist 50 children with recurrent wheezing who are hospitalized for wheezing epizode. They received 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
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 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 |
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| Turkey | |
| Kecioren Education and Training Hospital | |
| Ankara, Kecioren, Turkey, 06380 | |
| 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: | NCT00733473 History of Changes |
| Other Study ID Numbers: | B.10.0.İEG.0.11.00.01-3246 |
| 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 |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases 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 May 16, 2013