REported Outcomes in COPD With Trixeo in Real worlD in Germany
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
475
1 country
62
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 Germany. 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, physical activity, sleep quality, treatment satisfaction, and inhaled medication adherence through electronic surveys.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
Typical duration for all trials
62 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
Study Start
First participant enrolled
March 15, 2022
CompletedFirst Submitted
Initial submission to the registry
March 28, 2022
CompletedFirst Posted
Study publicly available on registry
April 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 16, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 16, 2024
CompletedJuly 1, 2025
June 1, 2025
2.3 years
March 28, 2022
June 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in COPD Assessment Test (CAT) score after 3 months treatment
To describe the change in COPD health status after 3 months of treatment vs baseline in eligible COPD patients initiated with TRIXEO treatment
3 months
Secondary Outcomes (6)
Change from baseline in CAT score after 1, 6 and 12 months treatment
12 months
Change from baseline in St George's Respiratory Questionnaire (SGRQ) score after 3 and 12 months treatment
12 months
Change from baseline in activity limitations, measured by CAT activity question/domain, after 1, 3 and 12 months of treatment
12 months
Change from baseline in activity limitations, measured by SGRQ activity question/domain, after 3 and 12 months of treatment
12 months
IQVIA Treatment Satisfaction Questionnaire for Medication (TSQM)© scores at baseline, 3 and 12 months
12 months
- +1 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 (62)
Research Site
Böblingen, Germany, 71032, Germany
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Doerfles-Esbach, Germany, 96487, Germany
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Fürstenwalde, Germany, 15517, Germany
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Marburrg, Germany, 35037, Germany
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Auerbach, 08209, Germany
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Augsburg, 86150, Germany
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Bad Neustadt A.d. Saale, 97616, Germany
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Bayreuth, 95445, Germany
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Beelitz, 14547, Germany
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Berlin, 10711, Germany
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Berlin, 10969, Germany
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Berlin, 12099, Germany
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Berlin, 12203, Germany
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Berlin, 12627, Germany
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Berlin, 13465, Germany
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Biberach, 88400, Germany
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Bremen, 28215, Germany
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Bremen, 28259, Germany
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Cottbus, 03050, Germany
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Darmstadt, 64283, Germany
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Dresden, 01324, Germany
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Düsseldorf, 40489, Germany
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Echterdingen, 70771, Germany
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Ehringshausen, 35630, Germany
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Filderstadt, 70794, Germany
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Flensburg, 24937, Germany
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Frankfurt, 60389, Germany
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Freiburg im Breisgau, 79104, Germany
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Fürth, 90762, Germany
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Halle, 06108, Germany
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Hamburg, 20354, Germany
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Hamburg, 22041, Germany
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Hattingen, 45525, Germany
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Ibbenbueren, 49477, Germany
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Kronach, 96317, Germany
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Laage, 18299, Germany
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Leipzig, 04103, Germany
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Marburg, 35037, Germany
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Markkleeberg, 04416, Germany
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Nuremberg, 90408, Germany
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Nuremberg, 90478, Germany
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Nuremberg, 90489, Germany
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Peißenberg, 82380, Germany
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Potsdam, 14467, Germany
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Potsdam, 14478, Germany
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Rathenow, 14712, Germany
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Rendsburg, 24768, Germany
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Rosenheim, 83022, Germany
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Rostock, 18055, Germany
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Roth, 91154, Germany
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Saalfeld, 07318, Germany
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Saarlouis, 66740, Germany
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Schleswig, 24837, Germany
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Teuchern, 06682, Germany
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Treuchtlingen, 91757, Germany
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Ulm, 89073, Germany
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Weißenburg, 91781, Germany
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Wiesbaden, 65183, Germany
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Wilhelmshaven, 26388, Germany
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Witten, 58452, Germany
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Würzburg, 97070, Germany
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Zirndorf, 90513, Germany
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
March 28, 2022
First Posted
April 5, 2022
Study Start
March 15, 2022
Primary Completion
July 16, 2024
Study Completion
July 16, 2024
Last Updated
July 1, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.