REported Outcomes in COPD With Trixeo in Real worlD
RECORD
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
1 other identifier
observational
150
1 country
31
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2022
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2021
CompletedFirst Posted
Study publicly available on registry
January 28, 2022
CompletedStudy Start
First participant enrolled
August 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2024
CompletedJuly 11, 2025
July 1, 2025
1.9 years
December 22, 2021
July 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
To describe the change in COPD health status after 3 months of treatment vs baseline in eligible COPD patients initiated with TRIXEO treatment
Change from baseline in COPD Assessment Test (CAT) score after 3 months treatment
3 months
Secondary Outcomes (7)
Describe change in COPD health status after 1, 6 and 12 months of treatment vs baseline in eligible COPD patients initiated with TRIXEO treatment
12 months
Describe change in health-related quality of life (HRQL) after 3 and 12 months vs baseline in eligible COPD patients initiated with TRIXEO treatment
12 months
Describe change in physical activity and activity limitations after 1, 3 and 12 months of treatment vs baseline in eligible COPD patients initiated with TRIXEO treatment
12 months
Describe change in physical activity and activity limitations after 1, 3 and 12 months of treatment vs baseline in eligible COPD patients initiated with TRIXEO treatment
12 months
Describe change in physical activity and activity limitations after 1, 3 and 12 months of treatment vs baseline in eligible COPD patients initiated with TRIXEO treatment
12 months
- +2 more secondary outcomes
Eligibility Criteria
The source population for this study is patients with moderate to severe COPD and who have been prescribed TRIXEO therapy in the primary care or hospital care setting may be enrolled in this study. Patients meeting all the inclusion criteria and none of the exclusion criteria may be enrolled by their physician. The decision to start treatment with TRIXEO has to be made by the treating physician according to the subjects' medical need and a positive benefit/risk balance. The decision is not part of the study, lies with the treating physician and is taken according to the standard of current best medical practice and national guidelines.
You may qualify if:
- Physician-diagnosed COPD
- Having been prescribed treatment with TRIXEO according to label and local market reimbursement criteria
- Patients must be able and willing to read and to comprehend written instructions, and to comprehend and complete the questionnaires required by the protocol
- After full explanation, patients must have signed an informed consent document indicating that they understand the purpose of and the procedures required for the study and are willing to participate in the study.
You may not qualify if:
- COPD due to α-1 antitrypsin deficiency
- Previous treatment with any other triple fixed-dose combination during screening
- Hospitalisation due to COPD exacerbation within the last 4 weeks prior to enrolment
- Pregnancy or lactation period
- Participation in an observational trial that might, in the investigator's opinion, influence the assessment for the current study, or participation in a randomised clinical trial in the last 30 days.
- Patient still recovering from Covid-19 infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (31)
Research Site
Ashton-under-Lyne, United Kingdom
Research Site
Bath, United Kingdom
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Belfast, United Kingdom
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Birkenhead, United Kingdom
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Bury St Edmunds, United Kingdom
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Carmarthen, United Kingdom
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Cippenham, United Kingdom
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Dewsbury, United Kingdom
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Gillingham, United Kingdom
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Gloucestershire, United Kingdom
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Greenisland, United Kingdom
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Hampshire, United Kingdom
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Harlow, United Kingdom
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Leeds, United Kingdom
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Leicester, United Kingdom
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Louth, United Kingdom
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Macclesfield, United Kingdom
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Manchester, United Kingdom
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Metropolitan Borough of Wirral, United Kingdom
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Mundesley, United Kingdom
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North Shields, United Kingdom
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Nuneaton, United Kingdom
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Prenton, United Kingdom
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Preston, United Kingdom
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Redruth, United Kingdom
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Rhyl, United Kingdom
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Stafford, United Kingdom
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Taunton, United Kingdom
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Waterlooville, United Kingdom
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Watford, United Kingdom
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Westcliff-on-Sea, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2021
First Posted
January 28, 2022
Study Start
August 11, 2022
Primary Completion
July 8, 2024
Study Completion
July 8, 2024
Last Updated
July 11, 2025
Record last verified: 2025-07