Chronic Obstructive Pulmonary DiseaseRECORDNCT05213611
REported Outcomes in COPD With Trixeo in Real worlD
An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 31 sites in United Kingdom.
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 to 130 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 150 participants
- Where
- 31 sitesUnited Kingdom
- Study dates
- 11 Aug 2022to 8 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 to 130 years
- 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
31 sites in 1 country.
31 sites in 1 country
United Kingdom31 sites
Research Site
Ashton-under-Lyne
Research Site
Bath
Research Site
Belfast
Research Site
Birkenhead
Research Site
Bury St Edmunds
Research Site
Carmarthen
Research Site
Cippenham
Research Site
Dewsbury
Research Site
Gillingham
Research Site
Gloucestershire
Research Site
Greenisland
Research Site
Hampshire
Research Site
Harlow
Research Site
Leeds
Research Site
Leicester
Research Site
Louth
Research Site
Macclesfield
Research Site
Manchester
Research Site
Metropolitan Borough of Wirral
Research Site
Mundesley
Research Site
North Shields
Research Site
Nuneaton
Research Site
Prenton
Research Site
Preston
Research Site
Redruth
Research Site
Rhyl
Research Site
Stafford
Research Site
Taunton
Research Site
Waterlooville
Research Site
Watford
Research Site
Westcliff-on-Sea
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 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Change from baseline in CAT score after 1, 6 and 12 months treatment
Measured: 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
Change from baseline in St George's Respiratory Questionnaire (SGRQ) score after 3 and 12 months treatment
Measured: 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
Change from baseline in device-measured steps per day after 3 and 12 months of treatment
Measured: 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
Change from baseline in activity limitations, measured by CAT activity question/domain, after 1, 3 and 12 months of treatment
Measured: 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
Change from baseline in activity limitations, measured by SGRQ activity question/domain, after 3 and 12 months of treatment
Measured: 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
IQVIA Treatment Satisfaction Questionnaire for Medication (TSQM)© scores at baseline, 3 and 12 months
Measured: 12 months
Describe change in physician-reported exacerbation rate (moderate and severe exacerbations) after 6 and 12 months vs baseline
Change from baseline in exacerbation rate (moderate, severe) after 6 and 12 months of 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 posted28 Jan 2022
- Study start11 Aug 2022
- Primary completion8 Jul 2024
- Study completion8 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213611
- Sponsor's protocol ID
- D5980R00051
- Acronym
- RECORD
- Status last verified
- Jul 2025
- First submitted
- 22 Dec 2021
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 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
- NCT05213611
- Acronym / sponsor ID
- RECORD / D5980R00051
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 8 Jul 2024 (actual)
- Study completion
- 8 Jul 2024 (actual)
- First posted
- 28 Jan 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 130 years
- 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
To describe the change in COPD health status after 3 months of treatment vs baseline in eligible COPD patients initiated with TRIXEO treatment
Time frame: 3 months
Change from baseline in COPD Assessment Test (CAT) score after 3 months treatment
7 secondary outcomes
Describe change in COPD health status after 1, 6 and 12 months of treatment vs baseline in eligible COPD patients initiated with TRIXEO treatment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months
Describe change in physician-reported exacerbation rate (moderate and severe exacerbations) after 6 and 12 months vs baseline
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 11 Jul 2025.
- CSR SynopsisLink provided by the sponsor.
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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.
31 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 31 sites in United Kingdom.
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 11 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 31 sites in United Kingdom. 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?
To describe the change in COPD health status after 3 months of treatment vs baseline in eligible COPD patients initiated with TRIXEO 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 11 Jul 2025.