Chronic Obstructive Pulmonary DiseaseRECORDNCT05311306
REported Outcomes in COPD With Trixeo in Real worlD in Germany
An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 62 sites in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 475 participants
- Where
- 62 sitesGermany
- Study dates
- 15 Mar 2022to 16 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
62 sites in 1 country.
62 sites in 1 country
Germany62 sites
Research Site
Auerbach, 08209
Research Site
Augsburg, 86150
Research Site
Bad Neustadt A.d. Saale, 97616
Research Site
Bayreuth, 95445
Research Site
Beelitz, 14547
Research Site
Berlin, 10711
Research Site
Berlin, 10969
Research Site
Berlin, 12099
Research Site
Berlin, 12203
Research Site
Berlin, 12627
Research Site
Berlin, 13465
Research Site
Biberach, 88400
Research Site
Böblingen, Germany, 71032
Research Site
Bremen, 28215
Research Site
Bremen, 28259
Research Site
Cottbus, 03050
Research Site
Darmstadt, 64283
Research Site
Doerfles-Esbach, Germany, 96487
Research Site
Dresden, 01324
Research Site
Düsseldorf, 40489
Research Site
Echterdingen, 70771
Research Site
Ehringshausen, 35630
Research Site
Filderstadt, 70794
Research Site
Flensburg, 24937
Research Site
Frankfurt, 60389
Research Site
Freiburg im Breisgau, 79104
Research Site
Fürstenwalde, Germany, 15517
Research Site
Fürth, 90762
Research Site
Halle, 06108
Research Site
Hamburg, 20354
Research Site
Hamburg, 22041
Research Site
Hattingen, 45525
Research Site
Ibbenbueren, 49477
Research Site
Kronach, 96317
Research Site
Laage, 18299
Research Site
Leipzig, 04103
Research Site
Marburg, 35037
Research Site
Marburrg, Germany, 35037
Research Site
Markkleeberg, 04416
Research Site
Nuremberg, 90408
Research Site
Nuremberg, 90478
Research Site
Nuremberg, 90489
Research Site
Peißenberg, 82380
Research Site
Potsdam, 14467
Research Site
Potsdam, 14478
Research Site
Rathenow, 14712
Research Site
Rendsburg, 24768
Research Site
Rosenheim, 83022
Research Site
Rostock, 18055
Research Site
Roth, 91154
Research Site
Saalfeld, 07318
Research Site
Saarlouis, 66740
Research Site
Schleswig, 24837
Research Site
Teuchern, 06682
Research Site
Treuchtlingen, 91757
Research Site
Ulm, 89073
Research Site
Weißenburg, 91781
Research Site
Wiesbaden, 65183
Research Site
Wilhelmshaven, 26388
Research Site
Witten, 58452
Research Site
Würzburg, 97070
Research Site
Zirndorf, 90513
About this study
Official 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
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.
Read more
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Lung Diseases, Obstructive, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Respiratory Tract Diseases
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Lung Diseases, Respiratory Tract Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (6)
Change from baseline in CAT score after 1, 6 and 12 months treatment
Describe change in COPD health status after 1, 6 and 12 months of treatment vs baseline in eligible COPD patients initiated with TRIXEO treatment
Measured: 12 months
Change from baseline in St George's Respiratory Questionnaire (SGRQ) score after 3 and 12 months treatment
Describe change in health-related quality of life (HRQL) after 3 and 12 months vs baseline in eligible COPD patients initiated with TRIXEO treatment
Measured: 12 months
Change from baseline in activity limitations, measured by CAT activity question/domain, after 1, 3 and 12 months of treatment
Describe change in physical activity and activity limitation at 1, 3, and 12 months of treatment vs baseline in eligible COPD patients initiated with TRIXEO treatment
Measured: 12 months
Change from baseline in activity limitations, measured by SGRQ activity question/domain, after 3 and 12 months of treatment
Describe change in physical activity and activity limitation at 1, 3, and 12 months of treatment vs baseline in eligible COPD patients initiated with TRIXEO treatment
Measured: 12 months
IQVIA Treatment Satisfaction Questionnaire for Medication (TSQM)© scores at baseline, 3 and 12 months
Describe change in patient satisfaction with their inhalation device after 3 and 12 months vs baseline in eligible COPD patients initiated with TRIXEO treatment
Measured: 12 months
Change from baseline in exacerbation rate (moderate, severe) after 6 and 12 months of treatment
Describe change in physician-reported exacerbation rate (moderate and severe exacerbations) after 6 and 12 months vs baseline in eligible COPD patients initiated with TRIXEO treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start15 Mar 2022
- Primary completion16 Jul 2024
- Study completion16 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 475 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311306
- Sponsor's protocol ID
- D5980R00037
- Acronym
- RECORD
- Status last verified
- Jun 2025
- First submitted
- 28 Mar 2022
- Last updated
- 1 Jul 2025
- Results posted
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05311306
- Acronym / sponsor ID
- RECORD / D5980R00037
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Lung Diseases, Obstructive, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Respiratory Tract Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 475 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 16 Jul 2024 (actual)
- Study completion
- 16 Jul 2024 (actual)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline in COPD Assessment Test (CAT) score after 3 months treatment
Time frame: 3 months
To describe the change in COPD health status after 3 months of treatment vs baseline in eligible COPD patients initiated with TRIXEO treatment
6 secondary outcomes
Change from baseline in CAT score after 1, 6 and 12 months treatment
Time frame: 12 months
Change from baseline in St George's Respiratory Questionnaire (SGRQ) score after 3 and 12 months treatment
Time frame: 12 months
Change from baseline in activity limitations, measured by CAT activity question/domain, after 1, 3 and 12 months of treatment
Time frame: 12 months
Change from baseline in activity limitations, measured by SGRQ activity question/domain, after 3 and 12 months of treatment
Time frame: 12 months
IQVIA Treatment Satisfaction Questionnaire for Medication (TSQM)© scores at baseline, 3 and 12 months
Time frame: 12 months
Change from baseline in exacerbation rate (moderate, severe) after 6 and 12 months of treatment
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- D5980R00037\_CSR Synopsis\_redactedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
62 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 62 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in COPD Assessment Test (CAT) score after 3 months treatment (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.