TriOptimize: A prospective non-interventional Trial to document potential optimization of health related quality of life in COPD patients prescribed a fixed vs. free LAMA/LABA/ICS triple therapy

The primary goal of chronic obstructive pulmonary disease (COPD) therapy is the prevention of exacerbations and clinical deterioration. To achieve these goals, treatment adherence is a fundamental requirement. Non-adherence to physician's advice, however, is very common in COPD patients especially when drastic lifestyle changes (e.g. smoking cessation) and multiple inhalative therapies become necessary. This is usually the case for patients more severely affected by their COPD, thus forming a vicious cycle of disease worsening and non-adherence to treatment. The subjective effects of a treatment on the patients' quality of life are therefore not only important effectiveness measures, but also major determinants of treatment adherence, and thus, long-term therapy outcomes. The aim of this study is to bridge the clinical data from pivotal studies to real life. Special focus will be given to aspects which routinely under the settings of pivotal clinical trials cannot fully be seen; such as e.g. the influence of compliance/adherence-aspects in daily life or the effect of two vs. one inhaler in a double dummy setting. The primary objective is to assess changes in health related quality of life in COPD patients for whom the treating physician has decided to prescribe a fixed LAMA/LABA/ICS therapy consisting of glycopyrronium, formoterol and beclomethasone. Secondary objectives include the assessment of adherence to COPD therapy and reasons for non-adherence, use of rescue medication and adjustments of COPD therapy before and under the fixed triple therapy as well as treatment retention and changes in key spirometry parameters.