Asthma
Conditions
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.
Interventions
Pulmicort Respules 0.5mg/2cc
DEVICENitric Oxide Analyzer
Niox NO analyzer
Sponsors
AstraZeneca
AAADRS Clinical Research Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exhaled breath nitric oxide pre- to post treatment | two weeks |
Secondary
| Measure | Time frame |
|---|---|
| Spirometry with peak flow measurements and daily diary scores | two weeks |
Countries
United States
Outcome results
None listed