Effects of triple therapy on disease burden in patients of GOLD groups C and D: results from the observational COPD cohort COSYCONET.

"Disclosure The abstract of this paper was presented at the 63. DGP Conference (Kongress der Deutschen Gesellschaft für Pneumologie und Beatmungsmedizin) as a poster presentation with interim findings. The poster’s abstract was published in “Poster Abstracts” in Pneumologie Journal 2023;77(S01):79–79. Declarations Ethics approval and consent to participateAll assessments were approved by the central (Marburg [Ethikkommission FB Medizin Marburg]) and local (Bad Reichenhall [Ethikkommission bayerische Landesärztekammer]); Berlin (Ethikkommission Ärztekammer Berlin); Bochum (Ethikkommission Medizinische Fakultät der RUB); Borstel (Ethikkommission Universität Lübeck); Coswig (Ethikkommission TU Dresden); Donaustauf (Ethikkommission Universitätsklinikum Regensburg); Essen (Ethikkommission Medizinische Fakultät Duisburg-Essen); Gießen (Ethikkommission Fachbereich Medizin); Greifswald (Ethikkommission Universitätsmedizin Greifswald); Großhansdorf (Ethikkommission Ärztekammer Schleswig–Holstein); Hamburg (Ethikkommission Ärztekammer Hamburg); MHH Hannover/Coppenbrügge (MHH Ethikkommission); Heidelberg Thorax/Uniklinik (Ethikkommission Universität Heidelberg); Homburg (Ethikkommission Saarbrücken); Immenhausen (Ethikkommission Landesärztekammer Hessen); Kiel (Ethikkommission Christian-Albrechts-Universität zu Kiel); Leipzig (Ethikkommission Universität Leipzig); Löwenstein (Ethikkommission Landesärztekammer Baden-Württemberg); Mainz (Ethikkommission Landesärztekammer Rheinland-Pfalz); München LMU/Gauting (Ethikkommission Klinikum Universität München); Nürnberg (Ethikkommission Friedrich-Alexander-Universität Erlangen Nürnberg); Rostock (Ethikkommission Universität Rostock); Berchtesgadener Land (Ethikkommission Land Salzburg); Schmallenberg (Ethikkommission Ärztekammer Westfalen-Lippe); Solingen (Ethikkommission Universität Witten-Herdecke); Ulm (Ethikkommission Universität Ulm); Würzburg (Ethikkommission Universität Würzburg) ethical committees and written informed consent was obtained from all patients.The study was based on 2741 patients recruited within the COSYCONET framework (ClinicalTrials.gov, Identifier: NCT01245933). For further information see Karch A, Vogelmeier C, Welte T, Bals R, Kauczor HU, Biederer J, Heinrich J, Schulz H, Glaser S, Holle R et al.: The German COPD cohort COSYCONET: Aims, methods and descriptive analysis of the study population at baseline. Respir Med 2016, 114:27–37.For further information see:Karch A, Vogelmeier C, Welte T, Bals R, Kauczor HU, Biederer J, Heinrich J, Schulz H, Glaser S, Holle R et al.: The German COPD cohort COSYCONET: Aims, methods and descriptive analysis of the study population at baseline. Respir Med. 2016;114:27–37. Consent for publicationWithin the ethical approval of COSYCONET, the participants of the study gave their consent to publish the data collected without reference to their person. Competing interestsThe authors declare no competing interests. Competing interests The authors declare no competing interests."

"We are grateful to all COSYCONET study centers, especially to all study nurses, for their excellent and enduring work in data collection, as well as to all patients who were willing to participate in this study. COSYCONET is supported by the German Federal Ministry of Education and Research (BMBF) Competence Network Asthma and COPD (ASCONET) and performed in collaboration with the German Center for Lung Research (DZL). The project is funded by the BMBF with grant number 01 GI 0881, and is supported by unrestricted grants from AstraZeneca GmbH, Bayer Schering Pharma AG, Boehringer Ingelheim Pharma GmbH & Co. KG, Chiesi GmbH, GlaxoSmithKline, Grifols Deutschland GmbH, MSD Sharp & Dohme GmbH, Mundipharma GmbH, Novartis Deutschland GmbH, Pfizer Pharma GmbH, Takeda Pharma Vertrieb GmbH & Co. KG, Teva GmbH for patient investigations and laboratory measurements. The funding body had no involvement in the design of the study, or the collection, analysis or interpretation of the data."

"Data from visit 1 (baseline, n = 2741) and visit 3 (18-month follow-up, n = 2053) of the COSYCONET cohort were used. These visits took place in 2010 until 2015. Further information about the study and its inclusion/exclusion criteria can be found elsewhere []. Patients were categorized into GOLD grades according to spirometry and into GOLD groups A-D according to exacerbations and symptoms [], using the modified Medical Research Council (mMRC) questionnaire. The present analysis was restricted to patients of grades 1–4 at visit 1 (n = 2291) and further limited to those categorized as groups C or D at visits 1 and 3 (n = 268) in order to satisfy the formal criteria for triple therapy at both visits. The requirement of completeness of data resulted in the exclusion of 10 patients and thus a final study population of 258 patients, among them 96 of group C and 162 of group D. The protocol of COSYCONET was approved by the ethical committees of all study centers, and all patients gave their written informed consent. The study is registered under the identifier NCT01245933 (first registration 23/11/2010). COSYCONET was approved by the ethics committees of all study centers and conducted in accordance with the Declaration of Helsinki."