Effect of Budesonide on Exhaled Nitric Oxide in Asthmatic Children

Verified by: AAADRS Clinical Research Center, January 2009
First Received: August 28, 2007 | Last Updated: January 22, 2009 | Phase: Phase 4 | Start Date: August 2007
Overall Status: Completed | Estimated Enrollment: 16
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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...

Brief Summary

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: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: December 2008

Detailed Clinical Trial Description

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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: AAADRS Clinical Research Center Other

Overall Clinical Trial Officials and Contacts

Miguel J Lanz, MD Principal Investigator Principal Investigator  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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