Chapman, Kenneth R.
Watz, Henrik
Singh, Dave
Hohlfeld, Jens M.
Diamant, Zuzana
Jones, Ieuan
Tillmann, Hanns-Christian
Nikolaev, Ivan http://orcid.org/0000-0003-4501-2083
Funding for this research was provided by:
Novartis
Article History
Accepted: 22 March 2021
First Online: 17 April 2021
Declarations
:
: The studies were funded by Novartis Institutes for BioMedical Research. The funder had a role in the study design, data collection, data analysis and interpretation, and writing of the manuscript.
: Kenneth R. Chapman reports grants and personal fees from AstraZeneca, Boehringer Ingelheim, Grifols, GlaxoSmithKline, Sanofi, Regeneron, Novartis and Takeda. Kenneth R. Chapman also received personal fees from CSL Behring, Inhibrx and Kamada, and grants from Vertex, outside the submitted work. Henrik Watz reports grants, personal fees and non-financial support from Novartis, during the conduct of the study; grants, personal fees and non-financial support from AZ, BerlinChemie/Menarini, GlaxoSmithKline, Chiesi, Bayer and Takeda, outside the submitted work. Dave Singh reports personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, Genentech, GlaxoSmithKline, Glenmark, Gossamerbio, Menarini, Mundipharma, Novartis, Peptinnovate, Pfizer, Pulmatrix, Theravance and Verona, outside the submitted work. Jens M. Hohlfeld reports grants from Novartis during the conduct of the study. Jens M. Hohlfeld also reports personal fees from Boehringer Ingelheim, Merck & Co, Inc., Novartis and HAL; and grants from AstraZeneca AB, Novartis, Janssen Pharmaceutica NV, ALK, Boehringer Ingelheim, LETI, GlaxoSmithKline, Sanofi-Aventis, Astellas Pharma and Allergopharma, outside the submitted work. In the past 3 years, Zuzana Diamanat acted as the Research Director at QPS-NL, an institution that received research support from several bio-pharmaceutical companies, especially within respiratory field: Patara Pharma (now Respivant), Novartis, Foresee Pharmaceuticals. Furthermore, Zuzana Diamanat received honoraria or speaker fees for serving on advisory boards or acting as a consultant from ALK, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, HAL Allergy, Merck Sharp & Dohme and Sanofi-Genzyme-Regeneron. In addition, Zuzana Diamanat also acts as an advisor for BMR BV, which holds patents for several respiratory indications. Ieuan Jones and Ivan Nikolaev are employees of Novartis. Hanns-Christian Tillmann is an employee of Novartis Institutes for Biomedical Research and owns Novartis shares.
: The study was conducted in accordance with the Declaration of Helsinki and was approved by the independent ethics committees of participating sites in Europe and China.
: Written informed consent was obtained from each patient before conducting any study-specific procedures.
: Not applicable.
: Novartis is committed to sharing with qualified external researchers access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided are anonymized to respect the privacy of patients who have participated in the study in line with applicable laws and regulations. This study data availability is according to the criteria and process described on ExternalRef removed.
: Not applicable.
: KRC, IJ, HCT and IN conceptualised this responder analysis. HW, DS, JHM, ZD and HCT designed the studies. HW, DS, JHM and ZD were responsible for data acquisition. IJ was involved in the extraction of the data and statistical analyses. All the authors were involved in the interpretation of the results and the writing and critical revision of the manuscript with the support of professional medical writers mentioned in the Acknowledgements section. All authors provided final approval on the version to be submitted.