Effect of Budesonide on Exhaled Nitric Oxide in Asthmatic Children - Tabular View

Tracking Information

First Received Date ^ICMJE

August 28, 2007

Last Updated Date

January 22, 2009

Start Date ^ICMJE

August 2007

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Exhaled breath nitric oxide pre- to post treatment [ Time Frame: two weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Exhaled breath nitric oxide pre- to post treatment [ Time Frame: two weeks ]

Change History

Complete list of historical versions of study NCT00522782 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Spirometry with peak flow measurements and daily diary scores [ Time Frame: two weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Spirometry with peak flow measurements and daily diary scores [ Time Frame: two weeks ]

Descriptive Information

Brief Title ^ICMJE

Effect of Budesonide on Exhaled Nitric Oxide in Asthmatic Children

Official Title ^ICMJE

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

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: Nebulized Budesonide
Device: Nitric Oxide Analyzer

Study Arms / Comparison Groups

Active Comparator: Nebulized budesonide

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2009

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

4 Years to 6 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00522782

Responsible Party

Miguel Lanz, MD, AAADRS

Study ID Numbers ^ICMJE

IRUSBUPR-0062

Study Sponsor ^ICMJE

AAADRS Clinical Research Center

Collaborators ^ICMJE

AstraZeneca

Investigators ^ICMJE

Principal Investigator:

Miguel J Lanz, MD

Principal Investigator

Information Provided By

AAADRS Clinical Research Center

Verification Date

January 2009

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