Funding for this research was provided by:
Chiesi Farmaceutici (Not applicable)
Received: 12 June 2019
Accepted: 23 July 2019
First Online: 9 August 2019
Ethics approval and consent to participate
: The study was approved by independent ethics committees for each institution (see the Additional file InternalRef removed for details). All patients provided written informed consent prior to study start.
: Not applicable.
: Dave Singh received personal fees from Chiesi during the conduct of this study. Outside the submitted work, he reports grants and personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Glenmark, Menarini, Mundipharma, Novartis, Pfizer, Pulmatrix, Therevance, and Verona, and personal fees from Cipla, Genentech and Peptinnovate.Kai Michael Beeh declares that no personal payments were received from any pharmaceutical entity in the past five years. He is a full time employee of insaf Respiratory Research Institute. The institution has received compensation for services on advisory boards or consulting for Ablynx, Almirall, AstraZeneca, Berlin Chemie, Boehringer, Chiesi, Cytos, Mundipharma, Novartis, Pohl Boskamp, Zentiva. The institution has received compensation for speaker activities in scientific meetings supported by Almirall, AstraZeneca, Berlin Chemie, Boehringer, Cytos, ERT, GSK, Novartis, Pfizer, Pohl Boskamp, Takeda. The institution has received compensation for design and performance of clinical trials from Almirall, Altana/Nycomed, AstraZeneca, Boehringer, Cytos, GSK, Infinity, Medapharma, MSD, Mundipharma, Novartis, Parexel, Pearl Therapeutics, Pfizer, Revotar, Teva, Sterna, and Zentiva.Brendan Colgan has nothing to disclose.Oliver Kornmann’s institution received fees from Chiesi for conducting this study as a participating site. Dr. Kornmann reports personal fees as speaker or Advisory Board member from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Sanofi and Novartis.Brian Leaker has nothing to disclose.Henrik Watz reports personal fees from Chiesi during the conduct of the study. Outside the submitted work, Dr. Watz reports personal fees from Bayer, personal fees from GSK, personal fees from Boehringer Ingelheim, personal fees from Novartis, personal fees from AstraZeneca, personal fees from BerlinChemie, and personal fees from Roche.Germano Lucci, Silvia Geraci, Mirco Govoni, Aida Emirova, and Marie Anna Nandeuil are all employees of Chiesi, the sponsor of this trial.