Evaluation Inhaled Corticosteroids on Exhaled Nitric Oxide Gas Exchange
Overview
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.
Full Title of Study: “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 Type
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: October 2013
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.
Interventions
- Drug: fluticasone 100mcg/ salmeterol 50mcg
- inhaled fluticasone 100mcg/salmeterol 50mcg bid X 3 months
- Drug: fluticasone 250/salmeterol 50
- inhaled fluticasone 250/salmeterol 50 X 3 months to evaluate effect on lung function and exhaled nitric oxide
- Drug: salmeterol
- salmeterol 50 mcg by dry powder inhaler disk bid to evaluated effect on lung function and exhaled nitric oxide
- Drug: Salmeterol
- salmeterol 50mcg bid X 3months
- Drug: salmeterol and fluticasone propionate
- salmeterol 50mcg/fluticasone 250mcg by DPI bid
Arms, Groups and Cohorts
- long acting bronchodilator
- salmeterol 50mcg bid by DPI, no fluticasone in patients with COPD/emphysema to evaluate effect on bronchodilation and exhaled nitric oxide
- bronchodilator/ inhaled corticosteroid
- fluticasone 250mcg/salmeterol 50 mcg bid X 3momths to evaluate effect on lung function and exhaled nitric oxide
- C
- Fluticasone 100mcg/salmeterol 50mcg
Clinical Trial Outcome Measures
Primary Measures
- total exhaled, bronchial, and small airway/alveolar nitric oxide
- Time Frame: 3 months
Secondary Measures
- lung function
- Time Frame: 3 months
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 20 Years
Maximum Age: 85 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Arthur F Gelb MD
- Provider of Information About this Clinical Study
- Sponsor-Investigator: Arthur F Gelb MD, Arthur F Gelb MD – Gelb, Arthur F., M.D.
- Overall Official(s)
- Arthur F Gelb, MD, Principal Investigator, Arthur F Gelb Medical Corporation
Citations Reporting on Results
Gelb AF, Flynn Taylor C, Shinar C. Nitric Oxide gas exchange in COPD. Am J Respir Crit Care Med 2007; 174: A630.
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