Anti-inflammatory effects of tiotropium in patients with stable COPD

INTERVENTION: Trade Name: Spiriva respimat 2.5 mcg Product Name: Spiriva respimat Pharmaceutical Form: Inhalation powder Pharmaceutical form of the placebo: Inhalation powder Route of administration of the placebo: Inhalation use CONDITION: Chronic obstructive pulmonary disease (COPD) Therapeutic area: Diseases [C] ‐ Respiratory Tract Diseases [C08] PRIMARY OUTCOME: Main Objective: A decrease of leukotriene B4 in induced sputum will be the main parameter for assessing the anti‐inflammatory effects of 6 week treatment with tiotropium in patients with stable COPD Primary end point(s): The primary endpoint is leukotriene B4 decrease in induced sputum for assessing the anti‐inflammatory effects of 6 week treatment with tiotropium in patients with stable COPD Secondary Objective: Additionally, changes in sputum cell differentials and other cytokine parameters (protein, mRNA), blood cell differentials, CRP, and cytokine parameters, health related quality of life (CCQ, CAT) will be assessed as well as changes in post‐bronchdilator FEV1 Timepoint(s) of evaluation of this end point: Baseline and after treatment period of 6 weeks SECONDARY OUTCOME: Secondary end point(s): Changes in sputum cell differentials and other cytokine parameters (protein, mRNA), blood cell differentials, CRP, and cytokine parameters, health related quality of life (CCQ, CAT) will be assessed as well as changes in post‐bronchdilator FEV1 Timepoint(s) of evaluation of this end point: Baseline and after treatment period of 6 weeks INCLUSION CRITERIA: •Men or women, age >= 40 years •post‐bronchodilator FEV1 >= 1.5 Litres •smoking history of > 10 pack years. •Being in a stable phase of COPD, as judged by the investigator. No courses of systemic steroids last 4 weeks •Post‐bronchodilator FEV1 / FVC ratio < 70% and post‐bronchodilator FEV1 < 80%pred Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50