Effect of Budesonide on Exhaled Nitric Oxide in Asthmatic Children
Information source: AAADRS Clinical Research Center
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Nebulized Budesonide (Drug); Nitric Oxide Analyzer (Device)
Phase: Phase 4
Status: Recruiting
Sponsored by: AAADRS Clinical Research Center Official(s) and/or principal investigator(s):
Miguel J Lanz, MD, Principal Investigator, Affiliation: Principal Investigator
Overall contact:
Miguel J Lanz, MD, Phone: 305 445-0441, Email: mjlanz@pol.net
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.
Clinical Details
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 design: Treatment, Open Label, Active Control, Single Group Assignment, Efficacy Study
Primary outcome: Exhaled breath nitric oxide pre- to post treatment
Secondary outcome: Spirometry with peak flow measurements and daily diary scores
Detailed description:
Comparisons will be made before and after 2 week therapy of nebulized budesonide in children
not on prior anti-inflammatory medications.
Eligibility
Minimum age: 4 Years.
Maximum age: 6 Years.
Gender(s): Both.
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
Locations and Contacts
Miguel J Lanz, MD, Phone: 305 445-0441, Email: mjlanz@pol.net
AAADRS Clinical Research Center, Coral Gables, Florida 33134, United States; Recruiting
Miguel J Lanz, MD, Phone: 305-444-0441, Email: mjlanz@pol.net
Claudia E Lobo, LPN, Phone: 305 444-0441, Email: celobo822@yahoo.com
Miguel J Lanz, MD, Principal Investigator
Additional Information
Starting date: August 2007
Ending date: February 2009
Last updated: May 27, 2008
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