Effect of Budesonide on Exhaled Nitric Oxide in Asthmatic Children

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
AAADRS Clinical Research Center
ClinicalTrials.gov Identifier:
NCT00522782
First received: August 28, 2007
Last updated: January 22, 2009
Last verified: January 2009

August 28, 2007
January 22, 2009
August 2007
December 2008   (final data collection date for primary outcome measure)
Exhaled breath nitric oxide pre- to post treatment [ Time Frame: two weeks ] [ Designated as safety issue: No ]
Exhaled breath nitric oxide pre- to post treatment [ Time Frame: two weeks ]
Complete list of historical versions of study NCT00522782 on ClinicalTrials.gov Archive Site
Spirometry with peak flow measurements and daily diary scores [ Time Frame: two weeks ] [ Designated as safety issue: No ]
Spirometry with peak flow measurements and daily diary scores [ Time Frame: two weeks ]
Not Provided
Not Provided
 
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

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.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Asthma
  • Drug: Nebulized Budesonide
    Pulmicort Respules 0.5mg/2cc
    Other Name: Pulmicort Respules 0.5mg/2ml nebulized
  • Device: Nitric Oxide Analyzer
    Niox NO analyzer
    Other Name: Niox NO analyzer
Active Comparator: A
Nebulized budesonide
Interventions:
  • Drug: Nebulized Budesonide
  • Device: Nitric Oxide Analyzer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
January 2009
December 2008   (final data collection date for primary outcome measure)

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
Both
4 Years to 6 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00522782
IRUSBUPR-0062
Yes
Miguel Lanz, MD, AAADRS
AAADRS Clinical Research Center
AstraZeneca
Principal Investigator: Miguel J Lanz, MD Principal Investigator
AAADRS Clinical Research Center
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP