Role and pharmacological modulation of lug inflammation in chronic obstructive pulmonary disease (COPD)

INTERVENTION: Trade Name: FLIXOTIDE DISK 500 Pharmaceutical Form: Inhalation powder INN or Proposed INN: Fluticasone Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 500‐ Trade Name: SPIRIVA Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: Tiotropium bromide Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 18‐ CONDITION: chronic obstructive pulmonary disease ; MedDRA version: 12.1 Level: LLT Classification code 10008842 Term: Chronic bronchitis & emphysema PRIMARY OUTCOME: Main Objective: Study of the effects of therapy with inhaled glucocorticoids on neutrophil cell counts in sputum, iPF2alfa, a biomarker of oxidative stress, and endogenous anti‐inflammatory compounds (prostaglandin E, lipoxins) in exhaled breath condensate (EBC) and sputum supernatants in patients with chronic obstructive pulmonary disease (COPD). Primary end point(s): 1. Neutrophil cell counts in sputum Secondary Objective: 1) cellular analysis of induced sputum 2) measurement of fractional exhaled nitric oxide (FeNO) 3) measurement of biomarkers of systemic inflammation (serum C reactive protein, urinary iPF2alfa) 4) assessment of lung function 5) study of possible correlations between clinical, biochemical, cellular and functional parameters INCLUSION CRITERIA: 1. Patient is male or female, at least 40 years of age and no more than 85 years. 2. Patient has mild, moderate or severe COPD according to the GOLD guidelines with a FEV1/FVC < 70% and FEV1 > 30% of the predicted value. 3. Reversibility to short‐acting beta‐agonists (SABA) of less than 200 ml or less than 12% predicted value FEV1 4. No acute exacerbations in the previous 3 months 5. No history of systemic disease or other pulmonary disease 6. No treatment with inhaled or systemic glucocorticoids in the previous 3 weeks. 7. No history of asthma or atopic disease 8. Current treatment for COPD includes SABA alone as needed; patients on tiotropium before the beginning of the study will continue tiotropium; patients on a different antimuscarinic drug before the beginning of the study will continue bronchodilating treatment with tiotropium; patients on a LABA before the beginning of the study, will continue bronchodilating treatment with tiotropium 9. Ability