Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-04-09 @ 6:09 AM
Study NCT ID:
NCT02015767
Status:
COMPLETED
Last Update Posted:
2017-06-23
First Post:
2013-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Registry of Roflumilast In Real Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1950}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-21', 'studyFirstSubmitDate': '2013-12-13', 'studyFirstSubmitQcDate': '2013-12-13', 'lastUpdatePostDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of observed exacerbations', 'timeFrame': '12 months', 'description': 'Number of exacerbations observed during the study period and per patient per year'}], 'secondaryOutcomes': [{'measure': 'Severity of exacerbations', 'timeFrame': '12 months', 'description': 'Severity of exacerbations (proportion of exacerbations requiring systemic corticosteroid treatment and/or antibiotics or requiring hospitalization).'}, {'measure': 'Seasonal variation of exacerbation', 'timeFrame': '12 months', 'description': 'Seasonal variation of exacerbation during Roflumilast treatment.'}, {'measure': 'Number of hospitalizations due to COPD exacerbations', 'timeFrame': '12 months', 'description': 'Number of hospitalizations due to Chronic obstructive pulmonary disease (COPD) exacerbations per patient per year.'}, {'measure': 'Change from Baseline in lung function parameters (FEV1 and FEV1/FVC)', 'timeFrame': 'Baseline and Month 12', 'description': 'Change in lung function parameters parameters FEV1(Forced Expired Volume measured after 1 second expiration) and FEV1/FVC (Forced Vital Capacity) from Baseline to the last recorded value and to the end of the study.'}, {'measure': 'Change from Baseline in blood oxygen saturation', 'timeFrame': 'Baseline and Month 12', 'description': 'Change in blood oxygen saturation assessed with pulse oximetry from Baseline to the last recorded value and the end of the study.'}, {'measure': 'Percentage of compliance to treatment', 'timeFrame': '12 months', 'description': 'Estimated percentage of prescribed doses taken since the last date of data collection.'}, {'measure': 'Changes in concomitant administration of COPD maintenance treatments', 'timeFrame': '12 months', 'description': 'Changes in concomitant administration of COPD maintenance treatments since start of roflumilast treatment.'}, {'measure': 'Health status using the COPD Assessment Questionnaire (CAT)', 'timeFrame': 'Baseline, Month 6 and Month 12'}, {'measure': 'Change from Baseline in breathlessness', 'timeFrame': 'Baseline and Month 12', 'description': 'Change in breathlessness assessed using the Modified Medical Research Council (mMRC) dyspnoea scale, from Baseline to the end of observation.'}, {'measure': 'Number of Participants with adverse Drug Reactions (ADRs)', 'timeFrame': '12 months', 'description': 'An ADR is a response to an observed medicinal product which is noxious and unintended resulting not only from the authorised use of a medicinal product at normal doses, but also from medication errors and uses outside the terms of the marketing authorisation, including the misuse and abuse of the medicinal product.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Drug therapy'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4568&filename=PROFILE%20EU%20Synopsis.pdf', 'label': 'Related Info'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4568&filename=PROFILE%20Asia%20Synopsis.pdf', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'A patient registry to capture real life data and demonstrate the performance of roflumilast (Daxas®) in a standard clinical practice.', 'detailedDescription': 'The drug being tested in this observational study design is called roflumilast, but not as an therapeutic intervention. Roflumilast is approved for and marketed globally for maintenance treatment of severe Chronic Obstructive Pulmonary Disease (COPD) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment.\n\nThis study will capture real life data and demonstrate the performance of roflumilast in a standard clinical practice. The study will enroll approximately 1350 (EU)+600(North Asia) patients. This multi-centre trial will be conducted in at least 4 EU and 2 North Asian countries.\n\nThe overall time to participate in this study is 12 months. No visits, diagnostic procedures or monitoring will take place, which would not happen had the patient not been included in the study.\n\nParticipants will be followed according to usual practice and data recorded approximately at 6 months and at 12 months of roflumilast treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants prescribed roflumilast (Daxas®) according to local guidelines and marketing authorization.\n\nThe registry sites will comprise hospitals, and office-based physicians. The investigators will be mainly pulmonologists, or as per the standard practice of the specific country.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent to the data collection\n* Roflumilast (Daxas®) treatment initiated in Roflumilast (Daxas®) naïve patients at the time of registry\n\nExclusion Criteria:\n\nThere are no exclusion criteria per se. However it is expected that patients are treated according to locally approved marketing authorisation.'}, 'identificationModule': {'nctId': 'NCT02015767', 'briefTitle': 'Patient Registry of Roflumilast In Real Life', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Patient Registry of Roflumilast In Real Life', 'orgStudyIdInfo': {'id': 'RO-2455-407-RD'}, 'secondaryIdInfos': [{'id': 'U1111-1146-5619', 'type': 'OTHER', 'domain': 'WHO Unique Trial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Roflumilast', 'description': 'Participants prescribed roflumilast (Daxas®) according to local guidelines and marketing authorization.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pleven', 'country': 'Bulgaria', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'city': 'Razgrad', 'country': 'Bulgaria', 'geoPoint': {'lat': 43.53331, 'lon': 26.51849}}, {'city': 'Sofia', 'country': 'Bulgaria', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Troyan Municipality', 'country': 'Bulgaria', 'geoPoint': {'lat': 42.89427, 'lon': 24.71589}}, {'city': 'Vratsa', 'country': 'Bulgaria', 'geoPoint': {'lat': 43.21052, 'lon': 23.56312}}, {'city': 'Agrinio', 'country': 'Greece', 'geoPoint': {'lat': 38.62139, 'lon': 21.40778}}, {'city': 'Athens', 'country': 'Greece', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Edessa', 'country': 'Greece', 'geoPoint': {'lat': 40.8026, 'lon': 22.04751}}, {'city': 'Herakleion-Crete', 'country': 'Greece'}, {'city': 'Imitos', 'country': 'Greece'}, {'city': 'Kaisarianí', 'country': 'Greece', 'geoPoint': {'lat': 37.9634, 'lon': 23.76523}}, {'city': 'Kalamaria', 'country': 'Greece', 'geoPoint': {'lat': 40.5825, 'lon': 22.95028}}, {'city': 'Katerini', 'country': 'Greece', 'geoPoint': {'lat': 40.26956, 'lon': 22.50608}}, {'city': 'Nafpaktos', 'country': 'Greece', 'geoPoint': {'lat': 38.39167, 'lon': 21.8275}}, {'city': 'Pátrai', 'country': 'Greece', 'geoPoint': {'lat': 38.2462, 'lon': 21.73508}}, {'city': 'Peristeri', 'country': 'Greece', 'geoPoint': {'lat': 38.01539, 'lon': 23.69187}}, {'city': 'Piraeus', 'country': 'Greece', 'geoPoint': {'lat': 37.94203, 'lon': 23.64619}}, {'city': 'Ptolemaida', 'country': 'Greece', 'geoPoint': {'lat': 40.51472, 'lon': 21.67861}}, {'city': 'Pýrgos', 'country': 'Greece', 'geoPoint': {'lat': 37.67513, 'lon': 21.44102}}, {'city': 'Thessaloniki', 'country': 'Greece', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'city': 'Volos', 'country': 'Greece', 'geoPoint': {'lat': 39.36923, 'lon': 22.94769}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Arendal', 'country': 'Norway', 'geoPoint': {'lat': 58.46151, 'lon': 8.77253}}, {'city': 'Bergen', 'country': 'Norway', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'city': 'Elverum', 'country': 'Norway', 'geoPoint': {'lat': 60.88191, 'lon': 11.56231}}, {'city': 'Fredrikstad', 'country': 'Norway', 'geoPoint': {'lat': 59.2181, 'lon': 10.9298}}, {'city': 'Kongsvinger', 'country': 'Norway', 'geoPoint': {'lat': 60.19049, 'lon': 11.99772}}, {'city': 'Sandvika', 'country': 'Norway', 'geoPoint': {'lat': 64.46377, 'lon': 13.59125}}, {'city': 'Skien', 'country': 'Norway', 'geoPoint': {'lat': 59.20962, 'lon': 9.60897}}, {'city': 'Straume', 'country': 'Norway', 'geoPoint': {'lat': 68.6888, 'lon': 14.47205}}, {'city': 'Tønsberg', 'country': 'Norway', 'geoPoint': {'lat': 59.26754, 'lon': 10.40762}}, {'city': 'Banská Bystrica', 'country': 'Slovakia', 'geoPoint': {'lat': 48.73947, 'lon': 19.14932}}, {'city': 'Bardejov', 'country': 'Slovakia', 'geoPoint': {'lat': 49.29175, 'lon': 21.27271}}, {'city': 'Bratislava', 'country': 'Slovakia', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'city': 'Humenné', 'country': 'Slovakia', 'geoPoint': {'lat': 48.93707, 'lon': 21.91625}}, {'city': 'Malacky', 'country': 'Slovakia', 'geoPoint': {'lat': 48.43604, 'lon': 17.02188}}, {'city': 'Michalovce', 'country': 'Slovakia', 'geoPoint': {'lat': 48.75434, 'lon': 21.9195}}, {'city': 'Nitra', 'country': 'Slovakia', 'geoPoint': {'lat': 48.30763, 'lon': 18.08453}}, {'city': 'Považská Bystrica', 'country': 'Slovakia', 'geoPoint': {'lat': 49.12153, 'lon': 18.42169}}, {'city': 'Prešov', 'country': 'Slovakia', 'geoPoint': {'lat': 48.99923, 'lon': 21.2355}}, {'city': 'Revúca', 'country': 'Slovakia', 'geoPoint': {'lat': 48.68346, 'lon': 20.11734}}, {'city': 'Senica', 'country': 'Slovakia', 'geoPoint': {'lat': 48.67922, 'lon': 17.36697}}, {'city': 'Spišská Nová Ves', 'country': 'Slovakia', 'geoPoint': {'lat': 48.94464, 'lon': 20.56153}}, {'city': 'Štúrovo', 'country': 'Slovakia', 'geoPoint': {'lat': 47.79495, 'lon': 18.7175}}, {'city': 'Topoľčany', 'country': 'Slovakia', 'geoPoint': {'lat': 48.56361, 'lon': 18.16712}}, {'city': 'Busan', 'country': 'South Korea', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Daegu', 'country': 'South Korea', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Gwangju', 'country': 'South Korea', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Jeonju', 'country': 'South Korea', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Suwon', 'country': 'South Korea', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'AstraZeneca AstraZeneca', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}