Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:24 AM
Study NCT ID:
NCT07414134
Status:
COMPLETED
Last Update Posted:
2026-02-17
First Post:
2025-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exacerbations and Real-World Outcomes Among Patients With Chronic Obstructive Pulmonary Disease Following Severe Exacerbation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3598}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-11-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-10', 'studyFirstSubmitDate': '2025-10-28', 'studyFirstSubmitQcDate': '2026-02-10', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annualized COPD Exacerbation Event Rate', 'timeFrame': '180 days', 'description': 'Annualized rates of COPD exacerbation events observed from index date (qualifying exacerbation event) through study completion (or until end of data availability'}], 'secondaryOutcomes': [{'measure': 'Annualized Cardiopulmonary Event Rate', 'timeFrame': '180 days', 'description': 'Annualized rates of cardiopulmonary events observed from index date (qualifying exacerbation event) through study completion (until end of data availability)'}, {'measure': 'Annualized rate of all-cause mortality', 'timeFrame': '180 days', 'description': 'Annualized incidence of all-cause mortality observed from index date (qualifying exacerbation event) through study completion (until end of data availability)'}]}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'This real-world retrospective study will use de-identified administrative claims data and will examine patients with a diagnosis of COPD who have experienced a qualifying severe disease exacerbation and received subsequent treatment with BGF. Agreed COPD patient data from the Inovalon MORE2 Registry® and Centers for Medicare \\& Medicaid Services (CMS) 100% Medicare Fee for Service (FFS) database spanning from January 1, 2021 to the most recently available data (September 30th, 2024 for the MORE2 database, and December 31st, 2023 for the Medicare FFS database) will be used for this analysis. All patients will be required to present at least one prescription claim for BGF. Patients will also be required to show evidence of a qualifying severe COPD exacerbation event during the 180-day period preceding initiation of BGF. Index date will be set as the date of discharge from the qualifying severe exacerbation event.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The study population is selected to allow a clear comparison of outcomes according to the timing of BGF initiation following a severe COPD exacerbation. The overall sample will include adult (aged ≥40) patients with COPD who have experienced a qualifying severe COPD exacerbation and received treatment with BGF within 6 months. Patients should not have prior single inhaler triple therapy (SITT) use during the available history of patients' data preceding the qualifying index severe exacerbation and prior to initiating BGF treatment.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ≥ 1 prescription(s) fill for BGF on or following January 1, 2021\n* Patients must have evidence of a severe qualifying exacerbation event.\n\n * The qualifying severe exacerbation event discharge date must occur within the 180-day period preceding the initiation of BGF for classification of patients into prompt or delayed initiators of BGF.\n * The discharge date of the first (earliest) observed qualifying index exacerbation event will be set as the index date\n* ≥ 12 months of continuous health plan enrollment preceding the qualifying index exacerbation event date (baseline period)\n* ≥ 1 day of continuous enrollment following the qualifying index exacerbation date\n* Age ≥ 40 years on the qualifying index exacerbation date\n\nExclusion Criteria:\n\n* Presence of cancer diagnoses other than basal or squamous cell skin cancer during the baseline period preceding the index date or entire follow-up period\n* Presence of ≥2 claims with a diagnosis of interstitial fibrosis or sarcoidosis diagnoses during the period preceding the index date or entire follow-up period\n* Presence of SITT at any time during the entire available history of patients' data preceding the index date through BGF initiation"}, 'identificationModule': {'nctId': 'NCT07414134', 'briefTitle': 'Exacerbations and Real-World Outcomes Among Patients With Chronic Obstructive Pulmonary Disease Following Severe Exacerbation', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Exacerbations and Real-World Outcomes Among Patients With Chronic Obstructive Pulmonary Disease Following Severe Exacerbation (MITOS:EROS+DISCHARGE)', 'orgStudyIdInfo': {'id': 'D5980R00121'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prompt', 'description': 'Patients initiating BGF within 30-days of exacerbation', 'interventionNames': ['Drug: BGF- BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL']}, {'label': 'Delayed', 'description': 'Patients initiating BGF within 31-180 days of exacerbation', 'interventionNames': ['Drug: BGF- BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL']}], 'interventions': [{'name': 'BGF- BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL', 'type': 'DRUG', 'description': 'This is a real-world observational study evaluating the timing of BGF, post discharge.', 'armGroupLabels': ['Delayed', 'Prompt']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20878', 'city': 'Gaithersburg', 'state': 'Maryland', 'country': 'United States', 'facility': 'AstraZeneca', 'geoPoint': {'lat': 39.14344, 'lon': -77.20137}}], 'overallOfficials': [{'name': 'Della Varghese, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.\n\nYes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.', 'accessCriteria': 'When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}