Official Title: “Phase IV Study of the Effect of Nebulized Budesonide on Exhaled Nitric Oxide in Children, Four to Six Years of Age, With Asthma”

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.

Study Type: Interventional

Study Design: Treatment, Open Label, Active Control, Single Group Assignment, Efficacy Study

Study Primary Completion Date: December 2008

Comparisons will be made before and after 2 week therapy of nebulized budesonide in children not on prior anti-inflammatory medications.

Intervention(s) in this Clinical Trial

• Drug: Nebulized Budesonide
  • Pulmicort Respules 0.5mg/2cc
• Device: Nitric Oxide Analyzer
  • Niox NO analyzer

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
  • Nebulized budesonide

Primary Measures

• Exhaled breath nitric oxide pre- to post treatment
  • Time Frame: two weeks
    Safety Issue?: No

Secondary Measures

• Spirometry with peak flow measurements and daily diary scores
  • Time Frame: two weeks
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 4 Years

Maximum Age for this Clinical Trial: 6 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AAADRS Clinical Research Center

Overall Clinical Trial Officials and Contacts

Miguel J Lanz, MD Principal Investigator Principal Investigator  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00522782

Study ID Number: IRUSBUPR-0062

ClinicalTrials.gov Identifier: NCT00522782

Health Authority: United States: Institutional Review Board