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Effect of Budesonide on Exhaled Nitric Oxide in Asthmatic Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00522782
First Posted: August 30, 2007
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
AstraZeneca
Information provided by:
AAADRS Clinical Research Center
  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 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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:


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 ]

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

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
Active Comparator: A
Nebulized budesonide
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Miguel Lanz, MD, AAADRS
ClinicalTrials.gov Identifier: NCT00522782     History of Changes
Other Study ID Numbers: IRUSBUPR-0062
First Submitted: August 28, 2007
First Posted: August 30, 2007
Last Update Posted: October 12, 2017
Last Verified: January 2009

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Nitric Oxide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents