Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The HERMES Study (BY217/M2-125)

Post-bronchodilator FEV1 [L]

Mean change from baseline during the treatment period in post-bronchodilator FEV1 \[L\]

Time frame: Change from baseline over 52 weeks of treatment

Time to Mortality Due to Any Reason

Time frame: 52 weeks treatment period

Natural Log-transformed C-reactive Protein (CRP)

Mean change from baseline to the last post randomization measurement in natural log-transformed CRP

Time frame: Change from baseline to last post randomization measurement (52 weeks)

Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period

The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from -3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from -9 to +9.

Time frame: Change from baseline over 52 weeks of treatment