A year in the life of German patients with COPD: the DACCORD observational study

Roland Buhl,1 Carl-Peter Criée,2 Peter Kardos,3 Claus Vogelmeier,4,5 Nadine Lossi,6 Claudia Mailänder,6 Heinrich Worth7 1Pulmonary Department, Mainz University Hospital, Mainz, 2Department of Sleep and Respiratory Medicine, Evangelical Hospital Göttingen-Weende, Bovenden, 3Group Practice and Centre for Allergy, Respiratory and Sleep Medicine, Red Cross Maingau Hospital, Frankfurt am Main, 4Department of Medicine, Pulmonary, and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-University Marburg, 5German Center for Lung Research, Marburg, 6Clinical Research Primary Care, Novartis Pharma GmbH, Nürnberg, 7Facharztforum Fürth, Fürth, Germany Introduction: Randomized interventional trials generally recruit highly selected patients. In contrast, long-term, noninterventional studies can reflect standard of care of real-life populations. DACCORD (Die ambulante Versorgung mit langwirksamen Bronchodilatatoren: COPD-Register in Deutschland [Outpatient Care With Long-Acting Bronchodilators: COPD Registry in Germany]) is an ongoing observational study, conducted in primary and secondary care in Germany, aiming to describe the impact of disease and treatments on real-life patients with chronic obstructive pulmonary disease (COPD). Methods: Patients had a clinical and spirometry diagnosis of COPD, were aged ≥40 years, and were initiating or changing COPD maintenance medication. The only exclusion criteria were asthma and participation in a randomized clinical trial. Exacerbation data were collected every 3 months. COPD medication, COPD Assessment Test, and forced expiratory volume in 1 second (FEV1) were recorded at the end of the 1 year period. Results: In the 6 months prior to baseline, 26.5% of the 3,974 patients experienced ≥1 exacerbation, compared with 26.1% over the 1-year follow-up (annualized rate 0.384). Importantly, only previous exacerbations and not poor lung function alone predicted an increased exacerbation risk. There was a general shift to lower disease severity from baseline to 1 year, predominantly as a consequence of a lower proportion of patients considered at high risk due to exacerbations. COPD Assessment Test mean change from baseline was -1.9, with 48.9% of patients reporting a clinically relevant improvement. Overall persistence to medication was high, with 77.2% of patients still receiving the same class of medication at 1 year. Conclusion: DACCORD suggests that in clinical practice, the large majority of COPD patients are symptomatic but seldom exacerbate and that widely used tools and treatment recommendations do not reflect this fully. Keywords: COPD, epidemiology, COPD exacerbation

Effectiveness of Extrafine Single Inhaler Triple Therapy in Chronic Obstructive Pulmonary Disease (COPD) in Germany – The TriOptimize Study

Christian Gessner,1 Frederik Trinkmann,2,3 Sanaz Bahari Javan,4 Raimund Hövelmann,4 Valentina Bogoevska,4 George Georges,5 Elena Nudo,6 Carl-Peter Criée7 1Pneumologische Praxis Leipzig, Universitätsklinikum Leipzig, Institut für Klinische Immunologie, Leipzig, Germany; 2Pneumology and Critical Care Medicine, Thoraxklinik at University Hospital Heidelberg, Translational Lung Research Center Heidelberg (TLRC), Member of German Center for Lung Research (DZL), Heidelberg, Germany; 3Department of Biomedical Informatics (DBMI) at the Center for Preventive Medicine and Digital Health Baden-Württemberg (CPD-BW), University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany; 4Department of Medical Affairs, Chiesi GmbH, Hamburg, Germany; 5Corporate R&D, Chiesi USA Inc., Cary, NC, USA; 6Global Medical Affairs, Chiesi Farmaceutici S.p.A., Parma, Italy; 7Department of Sleep and Respiratory Medicine, Evangelical Hospital Goettingen-Weende, Bovenden, GermanyCorrespondence: Christian Gessner, Pneumologische Praxis Leipzig, Universitätsklinikum Leipzig, Institut für Klinische Immunologie, Tauchaer Straße 12, Leipzig, 04357, Germany, Tel +49 341 60 20 960, Email [email protected]: Real-word evidence on the effectiveness of switching from dual therapies or triple therapies (multiple inhalers) to extrafine single-inhaler triple therapy (efSITT), which consists of the inhaled corticosteroid (ICS) beclomethasone, the long-acting β2-agonist (LABA) formoterol and the long-acting muscarinic antagonist (LAMA) glycopyrronium, in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) is limited. The impact of switching to efSITT on health-related quality of life (HRQoL), COPD specific symptoms, lung function and treatment adherence were assessed in routine clinical care.Patients and Methods: Patients were recruited at 148 sites in Germany between 2017 and 2020 in this multicenter, non-interventional observational study. Demographics, clinical data and treatment history were collected at baseline. HRQoL (measured by COPD Assessment Test [CAT]), lung function and adherence (measured by Test of Adherence to Inhalers [TAI]) were assessed at baseline and after six months. Descriptive analyses were conducted by prior treatment and GOLD groups as well as for the overall population.Results: 55.1% of the 2623 included patients were male. Mean age was 65.8 years. 57.5% of the patients were previously treated with ICS+LABA+LAMA (multiple inhalers), 23.9% with ICS/LABA (single or two inhalers) and 18.6% with LAMA/LABA (single or two inhalers). After six months, largest mean improvements in the total CAT score were observed in the ICS/LABA (− 3.9) and LAMA/LABA (− 3.9) prior treatment groups as well as in patients in GOLD group B (− 2.9). In the overall population, the CAT items for cough, phlegm, and dyspnea decreased on average by − 0.4 points each. After six months, FEV1 increased by 2.0 percentage points in relation to predicted values. The percentages of measured sRtot and RV of predicted values decreased by 24.5 and 4.4 percentage points, respectively. The percentage of patients with good adherence increased from 67.8% to 76.5%.Conclusion: Treatment switch to efSITT resulted in an improvement of HRQoL, COPD specific symptoms, lung function parameters and adherence under real-world conditions.Keywords: COPD, extrafine single inhaler triple therapy, treatment adherence, CAT scor