Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
150 participants
OBSERVATIONAL
2022-08-11
2024-07-08
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Related Links
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Other Identifiers
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D5980R00051
Identifier Type: -
Identifier Source: org_study_id
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