Funding for this research was provided by:
GlaxoSmithKline (study number CTT116855)
Received: 26 September 2019
Accepted: 17 May 2020
First Online: 5 June 2020
Ethics approval and consent to participate
: All study patients provided written informed consent. The study protocol, any amendments, the informed consent, and other information that required pre-approval were reviewed and approved by a national, regional, or investigational site ethics committee or institutional review board (IRB), in accordance with the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice and applicable country-specific requirements, including United States 21 Code of Federal Regulations 312.3(b) for constitution of independent ethics committees.
: Not applicable.
: NC Day, S Kumar, CE Jones, M Kaisermann, S Kilbride, N Martin, and DA Lipson are GSK employees and hold stock/shares in GSK. G Criner has received personal fees from Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, CSA Medical, Eolo, GSK, HGE Technologies, Novartis, Nuvaira, Olympus, Pulmonx, Verona and NGM Bio. M Dransfield has received grant support from the Department of Defense and NIH; personal fees from AstraZeneca, Boehringer Ingelheim, PneumRx/BTG, Genentech, Boston Scientific, Quark Pharmaceuticals and GSK; and contracted clinical trial support from Boehringer Ingelheim, Novartis, AstraZeneca, Yungjin, PneumRx/BTG, Pulmonx, Boston Scientific and GSK. DMG Halpin has received personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Novartis, and Pfizer, and non-financial support from Boehringer Ingelheim and Novartis. MK Han has received personal fees from AstraZeneca, Boehringer Ingelheim, and GSK and research support from Novartis and Sunovion. P Lange has received personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, and GSK. DA Lomas has received personal fees from GSK. FJ Martinez has received personal fees and non-financial support from the American College of Chest Physicians, AstraZeneca, Boehringer Ingelheim, ConCert, Genentech, GSK, Inova Fairfax Health System, Miller Communications, National Society for Continuing Education, Novartis, Pearl Pharmaceuticals, PeerView Communications, Prime Communications, Puerto Rico Respiratory Society, Chiesi, Sunovion, Theravance, Potomac, University of Alabama Birmingham, Physicians Education Resource, Canadian Respiratory Network, Teva and Dartmouth; non-financial support from ProterrixBio, Gilead, Nitto and Zambon; and personal fees from Columbia University, Integritas, MD magazine, Methodist Hospital Brooklyn, New York University, UpToDate, WebMD/MedScape, Western Connecticut Health Network, Patara/Respivant, PlatformIQ, American Thoracic Society, Rockpointe, Rare Disease Healthcare Communications and France Foundation; grant support from NIH; and is a member of steering committees for Afferent/Merck, Biogen, Veracyte, Prometic, Bayer, Bridge Biotherapeutics and ProMedior. D Singh has received personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, Genentech, Glenmark, GSK, Menarini, Mundipharma, Novartis, Peptinnovate, Pfizer, Pulmatrix, Theravance, and Verona. R Wise has received personal fees from AstraZeneca/MedImmune, Boehringer Ingelheim, Contrafect, Pulmonx, Roche, Spiration, Sunovion, Merck, Circassia, GSK, Pneuma, Verona, Bonti, Denali, Aradigm, Mylan/Theravance, Propeller Health and AbbVie; and grant support from AstraZeneca/MedImmune, Boehringer Ingelheim, Pearl Therapeutics, GSK and Sanofi-Aventis.ELLIPTA is owned by or licensed to the GSK Group of Companies.