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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- total exhaled, bronchial, and small airway/alveolar nitric oxide
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Ecologic Or Community
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 20 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
long acting bronchodilator
salmeterol 50mcg bid by DPI, no fluticasone in patients with COPD/emphysema to evaluate effect on bronchodilation and exhaled nitric oxide
Intervention: Salmeterol (Drug)
bronchodilator/ inhaled corticosteroid
fluticasone 250mcg/salmeterol 50 mcg bid X 3momths to evaluate effect on lung function and exhaled nitric oxide
Intervention: fluticasone 250/salmeterol 50 (Drug)
bronchodilator/ inhaled corticosteroid
fluticasone 250mcg/salmeterol 50 mcg bid X 3momths to evaluate effect on lung function and exhaled nitric oxide
Intervention: salmeterol and fluticasone propionate (Drug)
C
Fluticasone 100mcg/salmeterol 50mcg
Intervention: fluticasone 100mcg/ salmeterol 50mcg (Drug)
C
Fluticasone 100mcg/salmeterol 50mcg
Intervention: Salmeterol (Drug)
Outcomes
Primary Outcomes
total exhaled, bronchial, and small airway/alveolar nitric oxide
Time Frame: 3 months
Secondary Outcomes
- lung function(3 months)
Investigators
Arthur F Gelb MD
Arthur F Gelb MD
Gelb, Arthur F., M.D.