Kocks, Janwillem
Bosnic-Anticevich, Sinthia
van Cooten, Joyce
Correia de Sousa, Jaime
Cvetkovski, Biljana
Dekhuijzen, Richard
Dijk, Lars
Garcia Pardo, Marina
Gardev, Asparuh
Gawlik, Radosław
van der Ham, Iris
Janse, Ymke
Lavorini, Federico
Maricoto, Tiago
Meijer, Jiska
Metz, Boyd
Price, David
Roman Rodriguez, Miguel
Schuttel, Kirsten
Stoker, Nilouq
Tsiligianni, Ioanna
Usmani, Omar
Voorham, Jaco
Leving, Marika T.
Article History
Received: 1 February 2023
Accepted: 16 July 2023
First Online: 17 August 2023
Declarations
:
: The PIFotal COPD study protocol has received approvals from the following institutional ethics committees/institutional review boards: Australia: Human Research Ethics Committee (HREC 3) University of Sydney; Greece: Research Ethics Committee University of Crete; Poland: Komisja Bioetyczna przy Beskidziej Izble Lekarskiej – Bielsko Biala; Komisji Bioetycznej przy Śląskiej Izbie Lekarskiej; Silesian Medical Society (Śląska Izba Lekarska); Bioethics Committee at Lower Silesian Medical Association; Bioethics Committee at the Medical University of Biaystok; Portugal: North Health Regional Administration (ARS Norte); Matosinhos Local Health Unit (ULS Matosinhos); Guimarães Hospital; Center Health Regional Administration (ARS Centro); Regional Health Administration of Lisbon and Tagus Valley (ARS LVT); Spain: Comité de Ética de la Investigación (CEI) Islas Baleares; CEI Hospital Universitario de Gran Canaria; The Netherlands: Medisch Ethische Toetsingscommissie (METC) Assen exempted this study. All methods of this study were carried out in accordance with relevant (inter-)national guidelines and regulations, and all subjects gave written informed consent.
: Not applicable.
: JK reports grants, personal fees, and non-financial support from AstraZeneca, GSK, and Boehringer Ingelheim; grants and personal fees from Chiesi Pharmaceuticals and TEVA; grants from Mundipharma; personal fees from MSD and COVIS Pharma; and also holds 72.5% of shares in the General Practitioners Research Institute and 4% of shares in Lothar MedTec GmbH.SB-A has received grants from TEVA, and personal fees from TEVA, Boehringer Ingelheim, AstraZeneca, GSK, Sanofi and Mylan.JCdS reports or personal fees from AstraZeneca, Bial, Boehringer Ingelheim, GSK, Medinfar, Mundipharma and Sanofi.BC received an honorarium from GSK and Sanofi.JvC, LD, IvdH, YJ, BM, KS, NS, TM, BM, ML were employed by General Practitioners Research Institute (GPRI) at the time of the study. In the past three years (2020–2023), GPRI conducted investigator- and sponsor-initiated research funded by non-commercial organizations, academic institutes, and pharmaceutical companies (including AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Mundipharma, Novartis, Teva, Valneva, Eli Lilly and G3P).RD has received grants and personal fees from TEVA, Boehringer Ingelheim, AstraZeneca, GSK, Chiesi, Focus Care, and Glenmark.RG has received personal fees from AstraZeneca, GSK, and Chiesi.MGP receives grants from AstraZeneca, GSK and Boehringer Ingelheim.AG is an employee of Boehringer Ingelheim.FL received grants and personal fees from GSK, personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Menarini International, Novartis, Orion, and Trudell International, outside the submitted work.TM has no competing interests to declare.JM received grants from Boehringer Ingelheim, during the conduct of the study; and grants from AstraZeneca, Chiesi, Novartis, and GSK, outside the submitted work.DP reports grants and personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Theravance and Zentiva (Sanofi Generics); grants from the British Lung Foundation, Respiratory Effectiveness Group, UK National Health Service, and AKL Research and Development Ltd; personal fees from Cipla, GlaxoSmithKline, Kyorin, Merck, Mundipharma, Airway Vista Secretariat, EPG Communication Holdings Ltd, FIECON Ltd, Fieldwork International, OM Pharma SA, PeerVoice, Phadia AB, Spirosure Inc, Strategic North Limited, Synapse Research Management Partners S.L., Talos Health Solutions, and WebMD Global LLC; non-financial support from Efficacy and Mechanism Evaluation programme and Health Technology Assessment; stock/stock options from AKL Research and Development Ltd, which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 92.61% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); and 5% shareholding in Timestamp, which develops adherence monitoring technology.MR-R receives grants and personal fees from AstraZeneca and GSK; and personal fees from Boehringer Ingelheim, Chiesi, Menarini, Mundipharma, Novartis, Pfizer, TEVA and BIAL.IT reports grants and personal fees from GSK, AstraZeneca, Boehringer Ingelheim, Menarini, Novartis, Chiesi and Elpen.OU reports grants and personal fees from AstraZeneca, Boehringer Ingelheim, Edmond Pharma, Chiesi and GSK; grants from Edmond Pharma; and personal fees from Napp, Mundipharma, Sandoz, Takeda, Cipla, COVIS, Novartis, Mereobiopharma, Orion, and Menarini.JV has no competing interests to declare.