Viewing Study NCT02552160

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Ignite Creation Date: 2025-12-25 @ 2:11 AM
Ignite Modification Date: 2026-01-31 @ 4:00 PM
Study NCT ID: NCT02552160
Status: COMPLETED
Last Update Posted: 2018-12-11
First Post: 2015-07-29
Is Gene Therapy: True
Has Adverse Events: False
Brief Title: DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3732}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-10', 'studyFirstSubmitDate': '2015-07-29', 'studyFirstSubmitQcDate': '2015-09-16', 'lastUpdatePostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung function', 'timeFrame': 'First visit (baseline)', 'description': 'Assessment of FEV1 (Forced Expiratory Volume), FVC (Forced Vital Capacity)'}, {'measure': 'Number of patients with concomitant diseases classified by diagnostic subgroups', 'timeFrame': 'First visit (baseline)'}, {'measure': 'Number of patients receiving concomitant COPD (Chronic obstructive pulmonary disease) medication classified by therapeutic subgroups', 'timeFrame': 'First visit (baseline)'}, {'measure': 'Number of patients with exacerbations within the previous 24 months', 'timeFrame': 'First visit (baseline)', 'description': 'History of previous exacerbations that will be collected at first observational visit.'}], 'secondaryOutcomes': [{'measure': 'Change in well-being and quality of life', 'timeFrame': 'First visit (baseline) to end of observational period at 12 months', 'description': 'CAT (COPD Assessment Test™) questionnaire will be completed at each visit, approximately every 3 months.'}, {'measure': 'Effect on the severity of the shortness of breath', 'timeFrame': 'First visit (baseline) to end of observational period at 12 months', 'description': 'mMRC (modified Medical Research Council Dyspnea Scale) questionnaire will be completed at each visit, approximately every 3 months.'}, {'measure': 'Change in the night-time and early-morning COPD symptoms', 'timeFrame': 'First visit (baseline) to end of observational period at 12 months', 'description': 'NiSCI/EMSCI (Night-time symptoms of COPD Instrument / Early-morning symptoms of COPD instrument) questionnaire will be completed at each visit, approximately every 3 months.'}, {'measure': 'Lung function', 'timeFrame': 'First visit (baseline) to end of observational period at 12 months', 'description': 'Assessment of FEV1, FVC at each visit, approximately every 3 months.'}, {'measure': 'Number of exacerbations by grade', 'timeFrame': 'First visit (baseline) to end of observational period at 12 months', 'description': 'Number of exacerbations will be collected at each visit, approximately every 3 months'}, {'measure': 'Adverse events', 'timeFrame': 'First visit (baseline) to end of observational period at 12 months', 'description': 'Adverse events will be collected at each visit, approximately every 3 months.'}, {'measure': 'Handling of inhaler', 'timeFrame': 'At 12 months', 'description': 'Questionnaire regarding handling of inhaler by patient'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Obstructive Pulmonary Disease', 'Fixed-dose Combination', 'LAMA/LABA (Long Acting Beta2-Agonists / Long Acting Muscarinic Antagonists)', 'Inhaler', 'Aclidinium/Formoterol', 'Glycopyrronium/Indacaterol', 'Umeclidinium/Vilanterol'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3934&filename=DETECT_Report_Synopsis_20180720_final_Redacted_f_CTgov.pdf', 'label': 'CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'Prospective, multi-centre, non-interventional study to collect findings about the effects of LABA/LAMA (Long Acting Beta2-Agonists / Long Acting Muscarinic Antagonists) combination preparations on COPD (Chronic obstructive pulmonary disease) symptoms and quality of life under real conditions and to find out what types of patients are selected for this therapy by physicians.', 'detailedDescription': 'Retrospective aspect of documentation: For patients who have already been changed over to a fixed-dose combination, lung function parameters and CAT (COPD Assessment Test™) score from the time prior to the changeover will be documented.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have been diagnosed with COPD (Chronic obstructive pulmonary disease), who have been changed over within the last 3 months to one of the 3 listed fixed-dose combinations (FDC) or for whom such a changeover is intended, and whose lung function parameters and CAT (COPD Assessment Test™) score from the time prior to the changeover are available (within the last 6 months) or are determined at the time of the 1st visit, if this is planned as part of the routine treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female/male of at least 40 years of age\n* Patient diagnosed with COPD\n* Patient was changed over within the last 3 months to a fixed-dose combination (FDC) (Aclidinium/Formeterol, Glycopyrronium/Indacaterol or Umeclidinium/Vilanterol), or there is already the intent to change the patient over to a fixed-dose combination (Aclidinium/Formeterol, Glycopyrronium/Indacaterol or Umeclidinium/Vilanterol).\n* Lung function parameters and CAT score from the time prior to the changeover to an FDC are on record (within the last 6 months in the case of patients who have already been changed over) or are determined at the 1st visit (in the case of patients who have not yet been changed over but for whom such a changeover is intended).\n* Signed declaration of consent\n\nExclusion Criteria:\n\n* The prescribing information for the fixed-dose combinations (Duaklir® Genuair®, Ulibtro® Breezhaler® or Anoro®) list contraindications for the patient.\n* Patient is pregnant, plans to become pregnant, or is nursing during the therapy period.\n* Patient suffers from hypersensitivity to one of the active ingredients of the fixed-dose combinations.\n* Patient is participating in a clinical trial.'}, 'identificationModule': {'nctId': 'NCT02552160', 'acronym': 'DETECT', 'briefTitle': 'DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Non-interventional Study for Documentation of the Therapeutic Efficacy, Use and Tolerance of the Fixed-Dose Combinations (FDC) Duaklir® Genuair® (Aclidinium/Formoterol), Ultibro® Breezhaler® (Glycopyrronium/Indacaterol) and Anoro® (Umeclidinium/Vilanterol) in the Treatment of COPD Under Real Conditions in the Practices of Pneumologists, Internists, and General Practitioners', 'orgStudyIdInfo': {'id': 'D6570R00001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients on Duaklir® Genuair®', 'description': 'Patients on fixed-dose combination Duaklir® Genuair® (Aclidinium/Formoterol)'}, {'label': 'Patients on Ultibro® Breezhaler®', 'description': 'Patients on fixed-dose combination Ultibro® Breezhaler® (Glycopyrronium/Indacaterol)'}, {'label': 'Patients on Anoro®', 'description': 'Patients on fixed-dose combination Anoro® (Umeclidinium/Vilanterol)'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D6570R00001', 'city': 'Aachen', 'state': 'D6570r00001', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': 'D6570R00001', 'city': 'Aldenhofen', 'state': 'D6570r00001', 'country': 'Germany', 'facility': 'Research Site'}, {'zip': 'D6570R00001', 'city': 'Aldenhoven', 'state': 'D6570r00001', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.9, 'lon': 6.28333}}, {'zip': 'D6570R00001', 'city': 'Alzey', 'state': 'D6570r00001', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.74657, 'lon': 8.11513}}, {'zip': 'D6570R00001', 'city': 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