Pharmaceutical companies carry out further research to investigate long-term safety and effectiveness upon drug launch. One way is to undertake an observational study using the Clinical Practice Research Datalink (CPRD) consisting of anonymised primary care medical records. “Real-life” data from large numbers of patients can be analysed, enabling better understanding of current prescribing practices in relation to the drug being studied and establish the extent to which guidelines and licence indications are followed in the clinical setting.
Medicines and Healthcare products Regulatory Agency (MHRA) requested Mundipharma Research Limited to carry out a post-launch observational study of fluticasone-propionate/formoterol (FP/FOR) using the CPRD. FP/FOR was licensed for adult patients (≥ 12 years old) with asthma in September 2012. It is available either as a step-up therapy for patients whose asthma is not adequately controlled with their current treatments or as a maintenance therapy for those patients whose asthma is well controlled. Pharmaceutical companies must obtain a product licence from MHRA to advertise and sell a medicine. Off-label use of a drug is the use of a medicine different to that described in its licence. This study will characterise prescribing prevalence of licensed and off-label FP/FOR use and evaluate its safety.
This study aims to evaluate adverse events, prescribing prevalence and patient characteristics for patients initiating on FP/FOR or other FDC ICS/LABA therapies prescribed in the 18 months post launch of FP/FOR in the UK. It will be a historical cohort study within which four subgroups will be evaluated (adult patients (≥ 12 years) with asthma, patients with COPD (and no asthma), paediatric asthma patients 4–11 years, patients prescribed ICS/LABA as the “MART” regimen). Patients included have ≥1 prescriptions for any ICS/LABA fixed-dose combination from 2012. The number and percentage of patients prescribed FP/FOR and other FDC ICS/LABAs and the frequency and percentage of adverse events and patient characteristics including demographic characteristics, comorbidities, medication and disease-severity measures will be evaluated for patients prescribed FP/FOR and other FDC ICS/LABA therapies, and for each of the subgroups.
David Price - Chief Investigator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Jessica Martin - Corresponding Applicant - Wellcome Trust Sanger Institute
Derek Skinner - Collaborator - Research in Real Life ltd.( RiRl )
Frank Andersohn - Collaborator - Frank Andersohn Consulting & Research Services
Karin Maria Thelen - Collaborator - Mundipharma Research Ltd
Vicky Thomas - Collaborator - Cambridge Research Support Ltd.
HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data