Eligibility of patients with chronic obstructive pulmonary disease for inclusion in randomised control trials investigating triple therapy: a study using routinely collected data.

"Declarations Ethics approval and consent to participateCPRD has NHS Health Research Authority (HRA) Research Ethics Committee (REC) approval to allow the collection and release of anonymised primary care data for observational research [NHS HRA REC reference number: 05/MRE04/87]. Each year CPRD obtains Sect. 251 regulatory support through the HRA Confidentiality Advisory Group (CAG), to enable patient identifiers, without accompanying clinical data, to flow from CPRD contributing GP practices in England to NHS Digital, for the purposes of data linkage [CAG reference number: 21/CAG/0008]. The protocol for this research was approved by CPRD’s Research Data Governance (RDG) Process (protocol number: 22_002425) and the approved protocol is available upon request. Linked pseudonymised data was provided for this study by CPRD. Data is linked by NHS Digital, the statutory trusted third party for linking data, using identifiable data held only by NHS Digital. Informed consent for this study was not applicable. Rather, select general practices from CPRD consent to this process at a practice level with individual patients having the right to opt-out. Consent for publicationNot applicable. Competing interestsHW reports Grants from BRC outside the submitted work. AT has no competing interests. JQ reports Grants from BHF Data Science Centre, MRCm HDR UK, GSK, Asthma and Lung, AZ, Evidera, and Insemed outside of the submitted work and BI for this submitted work. Competing interests HW reports Grants from BRC outside the submitted work. AT has no competing interests. JQ reports Grants from BHF Data Science Centre, MRCm HDR UK, GSK, Asthma and Lung, AZ, Evidera, and Insemed outside of the submitted work and BI for this submitted work."

"Funding This project was funding by Boehringer Ingelheim as an investigator-initiated grant. The funder had no input into the methodology, data acquisition or analysis or interpretation of the findings."