Effect of Budesonide on Exhaled Nitric Oxide in Asthmatic Children
Phase 4
Completed
- Conditions
- Asthma
- Interventions
- Device: Nitric Oxide Analyzer
- Registration Number
- NCT00522782
- Lead Sponsor
- AAADRS Clinical Research Center
- Brief Summary
To study the improvement in airway inflammation in children with asthma non-invasively with exhaled breath NO, a marker of inflammation, after therapy with nebulized budesonide as 0.5mg daily.
- Detailed Description
Comparisons will be made before and after 2 week therapy of nebulized budesonide in children not on prior anti-inflammatory medications.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
- Asthma diagnosis previously for 6 months
- Past asthma medication without change for previous 6 months
- Increased NO levels and ability to perform maneuver
- ICF signed by parents
Exclusion Criteria
- Systemic steroids in past 60 days,inhaled/nebulized steroids in past 4 weeks
- Hospitalization within 3 months
- Upper or lower airways active infection or cigarette smoke direct exposure
- Use of other asthma medications other than bronchodilators one month prior and during the trial
- Noncompliance
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A Nitric Oxide Analyzer Nebulized budesonide A Nebulized Budesonide Nebulized budesonide
- Primary Outcome Measures
Name Time Method Exhaled breath nitric oxide pre- to post treatment two weeks
- Secondary Outcome Measures
Name Time Method Spirometry with peak flow measurements and daily diary scores two weeks
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms explain budesonide's anti-inflammatory effects in pediatric asthma?
How does nebulized budesonide compare to inhaled corticosteroids in reducing exhaled nitric oxide levels in children with mild to moderate asthma?
Which biomarkers correlate with exhaled nitric oxide reduction in response to nebulized budesonide therapy in preschool asthmatics?
What are the long-term safety profiles of nebulized budesonide in young asthmatic patients not previously treated with anti-inflammatory drugs?
Are there combination therapies involving budesonide and bronchodilators that enhance asthma control in children with eosinophilic airway inflammation?
Trial Locations
- Locations (1)
AAADRS Clinical Research Center
🇺🇸Coral Gables, Florida, United States
AAADRS Clinical Research Center🇺🇸Coral Gables, Florida, United States