[COPD and Clinical Trials. Results of an expert meeting "Castles in the Air" 2010]. / COPD und Studien. Ergebnisse des Expertentreffens Luftschlösser 2010, Mainz, 3.­4. Dezember 2010 (Sponsor: Boehringer Ingelheim Pharma GmbH & Co KG).

ABSTRACT

Clinical trials in COPD patients aim at achieving progress in diagnosis and treatment. Study results should be applicable to a large number of patients. However, an analysis of the methods and design of current and previous trials reveals considerable room for improvement. COPD is a complex disease with different clinical phenotypes. Genetic factors need to be evaluated systematically to allow appropriate stratification of patients. Frequently used endpoints such as the FEV1 that had previously been considered reliable have shown limitations in recent trials. Thus, researchers now aim to identify new surrogate parameters that are related to the prognosis of the disease, e. g., composite endpoints and biomarkers. Physical activity and capacity are becoming increasingly important for the evaluation of disease progression. The focus of pharmaceutical development is long acting bronchodilators and new anti-inflammatory drugs. The value of non-drug interventions will also be evaluated.