COPD und Studien

Zusammenfassung

Klinische Studien zur COPD haben zum Ziel, Fortschritte in der Diagnostik und Therapie der Erkrankung zu ermöglichen. Ihre Ergebnisse sollen für eine möglichst große Gruppe von Patienten anwendbar sein. Analysiert man aktuelle und ältere Studien genauer hinsichtlich ihrer Methodik und ihres Studiendesigns, werden Problembereiche sichtbar. Die COPD selbst ist eine komplexe Erkrankung mit unterschiedlichen Phänotypen. Genetische Grundlagen müssen systematischer untersucht werden, um eine Stratifizierung der Patienten zu ermöglichen. Vormals als robust eingeschätzte Zielparameter wie die FEV1 haben Grenzen, wie aktuelle Studien gezeigt haben. Dementsprechend wird nach neuen, prognoserelevanten Surrogat-Parametern gesucht, zu denen Komposit-Endpunkte und Biomarker gehören. Für die Beurteilung der Krankheitsprogression spielen körperliche Aktivität und Belastbarkeit eine zunehmende Rolle. Schwerpunkte der Medikamentenentwicklung sind lang wirksame Broncholytika und neue antiinflammatorische Substanzen. Zusätzlich wird der Wert nicht-medikamentöser Therapien evaluiert.

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.

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