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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