Trial | NCT00522782  Report issue

Title

Effect of Budesonide on Exhaled Nitric Oxide in Asthmatic Children
Phase IV Study of the Effect of Nebulized Budesonide on Exhaled Nitric Oxide in Children, Four to Six Years of Age, With Asthma

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    16
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.
Comparisons will be made before and after 2 week therapy of nebulized budesonide in children not on prior anti-inflammatory medications.
Study Started
Aug 31
2007
Primary Completion
Dec 31
2008
Study Completion
Jan 31
2009
Last Update
Jan 23
2009
Estimate

Drug Nebulized Budesonide

Pulmicort Respules 0.5mg/2cc

  • Other names: Pulmicort Respules 0.5mg/2ml nebulized

Device Nitric Oxide Analyzer

Niox NO analyzer

  • Other names: Niox NO analyzer

A Active Comparator

Nebulized budesonide

Criteria 

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
No Results Posted