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”

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.

Study Type: Interventional

Study Design: Diagnostic, Randomized, Single Blind (Outcomes Assessor), Active Control, Crossover Assignment, Bio-equivalence Study

Study Primary Completion Date: December 2008

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• No Intervention: A
  • salmeterol only, no fluticasone
• Active Comparator: B
  • fluticasone 250mcg/salmeterol 50 mcg bid X 3momths
• Active Comparator: C
  • Fluticasone 100mcg/salmeterol 50mcg

Primary Measures

• total exhaled, bronchial, and small airway/alveolar nitric oxide
  • Time Frame: 3 months
    Safety Issue?: No

Secondary Measures

• lung function
  • Time Frame: 3 months
    Safety Issue?: No

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 for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Gelb, Arthur F., M.D.

Overall Clinical Trial Officials and Contacts

Arthur F Gelb, MD Principal Investigator Arthur F Gelb Medical Corporation  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00569348

Study ID Number: 20061697

ClinicalTrials.gov Identifier: NCT00569348

Health Authority: United States: Institutional Review Board