Open Access funding enabled and organized by Projekt DEAL. Sponsorship for this trial and the journal’s Rapid Service and Open Access Fees were funded by G. Pohl-Boskamp GmbH & Co. KG, Hohenlockstedt, Germany.
Medical Writing, Editorial, and Other Assistance
The authors wish to thank all patients that participated in this trial and all investigators and members of the study teams for their expert help and contribution. Nicola Ryan is acknowledged for editorial assistance in the preparation of this article. In particular, Pharmalog Institut für Klinische Forschung GmbH, Ismaning, Germany, and Holger Stammer, Otto Wonhas and Dr. Norbert Gmeinwieser are acknowledged for their help in setting up and running the study.
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
All authors contributed to the design, conduct and evaluation of the study and were involved in planning, writing and review of the manuscript. Michael Dreher, Christian Grohè, Stephan Kanzler, Karin Kraft, Christoph Sarrazin, Michael Doll, Jens Spiesshöfer, Stephan Steiner, Jochen Wöhrle, Julia Seeger, and Stephan Eisenmann were involved as investigators, Michael Dreher also as co-ordinating investigator of the entire study.
Michael Dreher received consulting fees and honoraria for lectures from GSK, Boehringer Ingelheim, Novartis. Karin Kraft received grants from Schwabe, G. Pohl-Boskamp, and Pascoe and is President of the German Society of Phytotherapy. Kristina Röschmann-Doose, Jörn Thomsen, Thomas Wittig are employees of the sponsor of this RCT. Stephan Eisenmann received consulting fees from Actelion, Acceleron, Gilead, AstraZeneca, and Bess, support for attending meetings by Novartis and Boehringer Ingelheim and reports honoraria for lectures by the German Respiratory Society, Springer, Actelion, MSD, Gilead, AstraZeneca, Pulmonx, and Boehringer Ingelheim. Furthermore, he has served on Advisory Boards of Actelion, Acceleron, Gilead, AstraZeneca, and Boehringer Ingelheim. All other authors declare that they have no conflict of interest.
Compliance with Ethics Guidelines
The study was approved by the German Competent Authority (Federal Institute for Drugs and Medical Devices [Bundesinstitut für Arzneimittel und Medizinprodukte]) and the relevant independent ethics committees (lead: Faculty of Medicine, RWTH Aachen, Germany; approved 15 December 2021, reference number EK 408/20; for a complete list of ethic committees, see Supplementary Table S1). The study was performed in accordance with the Helsinki Declaration of 1964, and its later amendments. All subjects provided informed consent to participate in the study.
The datasets generated during and/or analysed during the current study are not publicly available due to confidentiality agreements.