Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
Study NCT ID:
NCT05311306
Status:
COMPLETED
Last Update Posted:
2025-07-01
First Post:
2022-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
REported Outcomes in COPD With Trixeo in Real worlD in Germany
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}], 'ancestors': [{'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 475}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-27', 'studyFirstSubmitDate': '2022-03-28', 'studyFirstSubmitQcDate': '2022-03-28', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in COPD Assessment Test (CAT) score after 3 months treatment', 'timeFrame': '3 months', 'description': 'To describe the change in COPD health status after 3 months of treatment vs baseline in eligible COPD patients initiated with TRIXEO treatment'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in CAT score after 1, 6 and 12 months treatment', 'timeFrame': '12 months', 'description': 'Describe change in COPD health status after 1, 6 and 12 months of treatment vs baseline in eligible COPD patients initiated with TRIXEO treatment'}, {'measure': "Change from baseline in St George's Respiratory Questionnaire (SGRQ) score after 3 and 12 months treatment", 'timeFrame': '12 months', 'description': 'Describe change in health-related quality of life (HRQL) after 3 and 12 months vs baseline in eligible COPD patients initiated with TRIXEO treatment'}, {'measure': 'Change from baseline in activity limitations, measured by CAT activity question/domain, after 1, 3 and 12 months of treatment', 'timeFrame': '12 months', 'description': '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'}, {'measure': 'Change from baseline in activity limitations, measured by SGRQ activity question/domain, after 3 and 12 months of treatment', 'timeFrame': '12 months', 'description': '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'}, {'measure': 'IQVIA Treatment Satisfaction Questionnaire for Medication (TSQM)© scores at baseline, 3 and 12 months', 'timeFrame': '12 months', 'description': 'Describe change in patient satisfaction with their inhalation device after 3 and 12 months vs baseline in eligible COPD patients initiated with TRIXEO treatment'}, {'measure': 'Change from baseline in exacerbation rate (moderate, severe) after 6 and 12 months of treatment', 'timeFrame': '12 months', 'description': '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'}]}, 'conditionsModule': {'keywords': ['Lung Diseases, Obstructive', 'Pulmonary Disease, Chronic Obstructive', 'Lung Diseases', 'Respiratory Tract Diseases'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5980R00037&attachmentIdentifier=43f18fe9-9e10-47c1-99ab-25d8e9b538da&fileName=D5980R00037_CSR_Synopsis_redacted.pdf&versionIdentifier=', 'label': 'D5980R00037\\_CSR Synopsis\\_redacted'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.\n\nThe 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.\n\nDemographic 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "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.\n\nThe 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.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Physician-diagnosed COPD\n* Having been prescribed treatment with TRIXEO according to label and local market reimbursement criteria\n* Patients must be able and willing to read and to comprehend written instructions, and to comprehend and complete the questionnaires required by the protocol\n* 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.\n\nExclusion Criteria:\n\n* COPD due to α-1 antitrypsin deficiency\n* Previous treatment with any other triple fixed-dose combination during screening\n* Hospitalisation due to COPD exacerbation within the last 4 weeks prior to enrolment\n* Pregnancy or lactation period\n* 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.\n* Patient still recovering from Covid-19 infection"}, 'identificationModule': {'nctId': 'NCT05311306', 'acronym': 'RECORD', 'briefTitle': 'REported Outcomes in COPD With Trixeo in Real worlD in Germany', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'D5980R00037'}}, 'contactsLocationsModule': {'locations': [{'zip': '71032', 'city': 'Böblingen', 'state': 'Germany', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 48.68212, 'lon': 9.01171}}, {'zip': '96487', 'city': 'Doerfles-Esbach', 'state': 'Germany', 'country': 'Germany', 'facility': 'Research Site'}, {'zip': '15517', 'city': 'Fürstenwalde', 'state': 'Germany', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.36067, 'lon': 14.06185}}, {'zip': '35037', 'city': 'Marburrg', 'state': 'Germany', 'country': 'Germany', 'facility': 'Research Site'}, {'zip': '08209', 'city': 'Auerbach', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.51155, 'lon': 12.40083}}, {'zip': '86150', 'city': 'Augsburg', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '97616', 'city': 'Bad Neustadt A.d. 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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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}