RECORD: REported Outcomes in COPD with Trixeo in Real worlD
Research type
Research Study
Full title
A non-interventional, multi-centre study to investigate the change in clinical and patient-reported outcomes in moderate to severe COPD patients treated with TRIXEO (Budesonide / Glycopyrronium / Formoterol) under real-life conditions
IRAS ID
308176
Contact name
Dave Singh
Contact email
Sponsor organisation
AstraZeneca
Duration of Study in the UK
1 years, 10 months, 28 days
Research summary
Chronic obstructive pulmonary disease (COPD) is characterized by persistent respiratory symptoms (including breathlessness, cough, and sputum production), which has a substantial impact on health-related quality of life (HRQoL). Medical treatment of COPD aims to reduce these symptoms, reduce exacerbations, and improve patients’ ability to perform exercise and daily activities. TRIXEO is a triple therapy indicated as a maintenance treatment in adult patients with moderate-to-severe COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist.
The RECORD study is a prospective, non-interventional study to be conducted in the United Kingdom (UK) and Germany. The study aims to generate data to describe the real world effectiveness of Trixeo for patients with COPD who receive Trixeo in routine clinical practice. It also aims describe patients HRQoL, physical activity and treatment satisfaction, and will explore patients’ sleep quality and adherence to inhalers in the real-world. This data may provide important information for practicing physicians.The study will include approximately 500 patients with moderate to severe COPD from approximately 50 sites (including hospitals and GP practices) in the UK. Patients eligible for TRIXEO therapy may be enrolled by their treating physicians. The decision to treat with TRIXEO must be independent of the study and made by the treating physician according to the patients’ medical need and local routine clinical practice. Patients data will be collected for 12 months after starting therapy with Trixeo.
Demographic and clinical data will be extracted from patients' health care records. Patient reported outcomes will be collected remotely by asking patients to answer questionnaires on health status and HRQoL, treatment satisfaction, and inhaled medication adherence through electronic surveys. Consenting patients´ physical activity and sleep data will be collected via a Fitbit armband device.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
22/YH/0044
Date of REC Opinion
24 Mar 2022
REC opinion
Further Information Favourable Opinion