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
Trial Locations
- Locations (1)
AAADRS Clinical Research Center
🇺🇸Coral Gables, Florida, United States