Effect of Budesonide on Exhaled Nitric Oxide in Asthmatic Children

This study has been completed.

First Received: August 28, 2007 Last Updated: January 22, 2009 History of Changes

Sponsor:	AAADRS Clinical Research Center
Collaborator:	AstraZeneca
Information provided by:	AAADRS Clinical Research Center
ClinicalTrials.gov Identifier:	NCT00522782

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: Nebulized Budesonide Device: Nitric Oxide Analyzer	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Nitric oxide Budesonide

U.S. FDA Resources

Further study details as provided by AAADRS Clinical Research Center:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	16
Study Start Date:	August 2007
Study Completion Date:	January 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Nebulized budesonide	Drug: Nebulized Budesonide Pulmicort Respules 0.5mg/2cc Device: Nitric Oxide Analyzer Niox NO analyzer

Detailed Description:

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

Eligibility

Ages Eligible for Study:	4 Years to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522782

Locations

United States, Florida
AAADRS Clinical Research Center
Coral Gables, Florida, United States, 33134

Sponsors and Collaborators

AAADRS Clinical Research Center

AstraZeneca

Investigators

Principal Investigator:

Miguel J Lanz, MD

Principal Investigator

More Information

No publications provided

Responsible Party:	AAADRS ( Miguel Lanz, MD )
Study ID Numbers:	IRUSBUPR-0062
Study First Received:	August 28, 2007
Last Updated:	January 22, 2009
ClinicalTrials.gov Identifier:	NCT00522782 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Vasodilator Agents
Antioxidants
Bronchial Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses
Free Radical Scavengers

Endothelium-Dependent Relaxing Factors
Immune System Diseases
Budesonide
Asthma
Anti-Asthmatic Agents
Cardiovascular Agents
Glucocorticoids
Protective Agents
Pharmacologic Actions
Nitric Oxide
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on February 08, 2010