Dataset from Safety and Effectiveness of Spiriva® in COPD (Chronic Obstructive Pulmonary Disease) Patients Under the Real Condition of Usual Practice

The purpose of this study is to monitor the change in the health status of severe COPD
patients after the initiation of Tiotropium therapy. This will be assessed by the physician's
global evaluation of the patient's health status on a 8-point scale. This measure has been
shown to correlate with a established standard measure of the patients health related quality
of life. The primary analysis in this trial will only include patients not pre-treated with a
long-acting beta-agonist to establish a clear efficacy signal in this patient population. As
the reality of COPD treatment nowadays is poly-pharmacy, a secondary analysis will analyse
patients who are pretreated with long-acting bronchodilators to put the changes in the health
status in a likely real world context. In parallel to these evaluations of the health status,
the lung function response of the patients will be assessed to gain an established objective
measure of treatment response.