- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00733473
Nebulized Budesonide for Children Who Are Hospitalized for Acute Wheezing
Phase 4 Study of Nebulized Budesonide for Children Who Are Hospitalized for Acute Wheezing
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Kecioren
-
Ankara, Kecioren, Turkey, 06380
- Kecioren Education and Training Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
Children will receive 1 mg nebulized budesonide 2 times a day up to 5 days
Other Names:
|
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
|
Children will receive 2 ml of nebulized saline 2 times a day up to 5 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to discharge from the hospital to home
Time Frame: 1-5 days
|
1-5 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pulmonary index score
Time Frame: 1 to 5 days
|
1 to 5 days
|
Respiratory rate
Time Frame: 1 to 5 days
|
1 to 5 days
|
Oxygen saturation
Time Frame: 1 to 5 days
|
1 to 5 days
|
Adverse reactions.
Time Frame: 1 to 5 days
|
1 to 5 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Signs and Symptoms, Respiratory
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Respiratory Sounds
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Budesonide
Other Study ID Numbers
- B.10.0.İEG.0.11.00.01-3246
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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