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
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.
Lay summary of study results:
This study looked at how well a medicine called TRIXEO works in everyday life for people with moderate to severe chronic obstructive pulmonary disease (COPD). TRIXEO is a triple combination inhaler that includes budesonide glycopyrronium and formoterol. The study took place in both Germany and the United Kingdom (UK). In the UK, 130 people with COPD took part across 28 locations. The average age was 68 and just over half (53.8%) were men. Most participants were current or former smokers (91.2%) and had other comorbidities (90.8%) mainly high blood pressure (36.2%). A fair number were unemployed (15.9%) or unable to work due to COPD (6.3%).The main goal was to see how COPD symptom burden changed using a questionnaire called the COPD Assessment Test (CAT). At the start UK participants had an average CAT score of 23.6. After 3 months of using TRIXEO the score dropped by 2.4 points and over half (56.3%) saw a meaningful improvement. At 6 months the score dropped by 3.0 points (61.4% saw meaningful improvements) and at 12 months by 0.7 points (46.2% saw meaningful improvements).
Health-related quality of life measured by the St. George’s Respiratory Questionnaire (SGRQ) also improved. Scores dropped by 4.8 points at 3 months and 3.8 points at 12 months with nearly half 47.8% at 3 months and 46.2% at 12 months of people reporting improvements. People with COPD were more satisfied with their treatment over time in terms of ease-of-use effectiveness and overall happiness with the medicine. Treatment satisfaction was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM-9). Satisfaction scores improved at both 3 and 12 months. At the start 58.6% of UK participants had COPD exacerbations (or flareups) with an average of 1.76 exacerbations per year. After 6 months this dropped by 5% and by 18% after 12 months.
Most people 69.2% with COPD kept taking their treatment though 30.8% stopped using TRIXEO within a year, mainly in the first 3 months. and 13.1% due to side effects.
Use of other COPD medicines went down especially oral corticosteroids (OCS) (from 46.2% to 20.3%) and antibiotics (from 18.5% to 8.9%). The COVID19 pandemic affected participants’ lives with nearly half seeing their symptoms worsen and having less contact with healthcare providers.In summary, TRIXEO helped improve COPD symptom burden health-related quality of life and treatment satisfaction for people with COPD in the UK.
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