Evaluation Inhaled Corticosteroids on Exhaled Nitric Oxide Gas Exchange
Information source: Gelb, Arthur F., M.D.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: COPD
Intervention: fluticasone 100mcg/ salmeterol 50mcg (Drug); fluticasone 250/salmeterol 50 (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Gelb, Arthur F., M.D. Official(s) and/or principal investigator(s):
Arthur F Gelb, MD, Principal Investigator, Affiliation: Arthur F Gelb Medical Corporation
Summary
To evaluate the role of inhaled corticosteroids to suppress nitric oxide gas exchange in
stable patients with moderate-to-severe COPD who are current non-smokers and not on oral
corticosteroids.
Clinical Details
Official title: Evaluation of the Effects of Varying Doses of Inhaled Corticosteroids on Suppression of Total Exhaled, Bronchial, and Alveolar Nitric Oxide as Markers of Endogenous Inflammation in Patients With Moderate-to-Severe COPD
Study design: Diagnostic, Randomized, Single Blind (Outcomes Assessor), Active Control, Crossover Assignment, Bio-equivalence Study
Primary outcome: total exhaled, bronchial, and small airway/alveolar nitric oxide
Secondary outcome: lung function
Detailed description:
Stable, non-smoking COPD patients not on oral corticosteroids will be randomized in single
blinded study to evaluate nitric oxide gas exchange at baseline, and subsequent effects of
fluticasone 100mcg/salmeterol 50mcg bid, and fluticasone 250mcg/salmeterol 50mcg bid. Primary
end points will include measurements of nitric oxide at varying expiratory flow rates to
calculate bronchial, and small airway/alveolar nitric oxide. Secondary end points will
evaluate lung function. Exhaled nitric oxide production presumably reflects endogenous
inflammation. Normal healthy, non-smoking controls will be used for comparison, with exhaled
nitric oxide measured before and after 3 weeks of low dose inhlaed corticosteroids.
Eligibility
Minimum age: 40 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Clinical diagnosis of copd
- Current non-smoker
- Not on oral corticosteroids
- Must be able to use Advair discus or salmeterol discus
Exclusion Criteria:
- Pregnancy
- Current smoker
- On corticosteroids
- Clinically unstable
Locations and Contacts
Arthur F Gelb MD, Lakewood, California 90712, United States
Arthur F Gelb MD, Lakewood, California 90712, United States
Additional Information
Starting date: January 2006
Ending date: March 2008
Last updated: December 5, 2007
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