Effect of Budesonide on Exhaled Nitric Oxide in Asthmatic Children

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. Identifier: NCT00522782
Recruitment Status : Completed
First Posted : August 30, 2007
Last Update Posted : January 23, 2009
Information provided by:
AAADRS Clinical Research Center

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Nebulized Budesonide Device: Nitric Oxide Analyzer Phase 4

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
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
Study Start Date : August 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Exhaled breath nitric oxide pre- to post treatment [ Time Frame: two weeks ]

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

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

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

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 identifier (NCT number): NCT00522782

United States, Florida
AAADRS Clinical Research Center
Coral Gables, Florida, United States, 33134
Sponsors and Collaborators
AAADRS Clinical Research Center
Principal Investigator: Miguel J Lanz, MD Principal Investigator

Responsible Party: Miguel Lanz, MD, AAADRS Identifier: NCT00522782     History of Changes
Other Study ID Numbers: IRUSBUPR-0062
First Posted: August 30, 2007    Key Record Dates
Last Update Posted: January 23, 2009
Last Verified: January 2009

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