Crapo, James D.
Gupta, Abhya
Lynch, David A.
Turner, Alice M.
Mroz, Robert M.
Janssens, Wim
Ludwig-Sengpiel, Andrea
Koegler, Harald
Eleftheraki, Anastasia
Risse, Frank
Diefenbach, Claudia
Clinical trials referenced in this document:
Documents that mention this clinical trial
FOOTPRINTS study protocol: rationale and methodology of a 3-year longitudinal observational study to phenotype patients with COPD
https://doi.org/10.1136/bmjopen-2020-042526
Baseline characteristics from a 3-year longitudinal study to phenotype subjects with COPD: the FOOTPRINTS study
https://doi.org/10.1186/s12931-023-02584-2
Funding for this research was provided by:
Boehringer Ingelheim
Article History
Received: 31 July 2023
Accepted: 27 October 2023
First Online: 17 November 2023
Declarations
:
: FOOTPRINTS<sup>®</sup> is being performed in accordance with the International Conference on Harmonisation Tripartite Guideline for GCP, the Japanese GCP regulations and local regulations. The protocol was approved by the authorities and IEC/IRB of the respective institutions where applicable, which included study sites in Belgium, Canada, Denmark, Finland, Germany, Japan, the Republic of Korea, Poland, Spain, Sweden, the United Kingdom and the United States. In the respective countries, the ethics approval preceded the study participant’s enrolment. Written informed consent is obtained from all study participants. Notably, any protocol amendments were initiated only after all required legal documentation was reviewed and/or approved by the respective IRB/IEC, as applicable.
: JC is a co-principal investigator for the COPDGene study and has received grants from National Institutes of Health/National Heart, Lung, and Blood Institute (NHLBI). AG, HK, AE, FR and CD are employees of Boehringer Ingelheim. DAL has received grants from NHLBI, and personal fees from Boehringer Ingelheim, and Calyx Inc. In addition, DAL has a patent for ‘systems and methods for classifying severity of COPD’ pending. AMT has received personal fees, payment for educational talks and expenses payments for work on the FOOTPRINTS steering committee from Boehringer Ingelheim, grants and personal fees from AstraZeneca, CSL Behring and Grifols Biotheraputics, and grants, personal fees and non-financial support from Chiesi. RMM has received personal fees from AstraZeneca, Boehringer Ingelheim, GSK, Merck Sharp & Dohme, Mundipharma, Novartis and Roche. WJ has received grants from AstraZeneca and Chiesi. AL-S reports receipt of a study fee for involvement in conducting the FOOTPRINTS study.