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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-25 @ 12:39 AM

Ignite Modification Date: 2025-12-25 @ 10:50 PM

Study NCT ID: NCT01285167

Status: COMPLETED

Last Update Posted: 2016-10-31

First Post: 2011-01-21

Is NOT Gene Therapy: False

Has Adverse Events: False

Brief Title: Quality of Life in Daxas-treated Patients Older Than 18 Years With Severe Chronic Obstructive Pulmonary Disease (COPD) (DACOTA)

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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C424423', 'term': 'Roflumilast'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3645}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-27', 'studyFirstSubmitDate': '2011-01-21', 'studyFirstSubmitQcDate': '2011-01-26', 'lastUpdatePostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre-/post comparison of the COPD status based on patients health status', 'timeFrame': 'after 6 months', 'description': 'Evaluation of treatment success by a COPD-specific patient questionnaire'}], 'secondaryOutcomes': [{'measure': 'Effectiveness during treatment', 'timeFrame': 'after 6 months', 'description': 'Evaluation of treatment success by a health status patient questionnaire'}, {'measure': 'Pre-/post comparison of spirometry data', 'timeFrame': 'after 6 months'}, {'measure': 'Evaluation of tolerability', 'timeFrame': 'after 6 months', 'description': 'assessment of adverse drug reactions'}, {'measure': 'Evaluation of symptom reduction of sputum and cough', 'timeFrame': 'after 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'Quality of life', 'lung function', 'spirometry', 'roflumilast', 'Daxas', 'severe COPD'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': "Chronic obstructive pulmonary disease (COPD) is a progressive and largely irreversible lung disease characterized by chronic bronchitis and/or emphysema, resulting in breathlessness, cough and sputum. As COPD progresses, patients experience increasing deterioration of their health-related quality of life, with greater impairment in their ability to work and declining participation in social and physical activities.\n\nThe aim of this non-interventional study is to evaluate data on quality of life in COPD patients in Germany in a real life medical setting under therapy with the phosphodiesterase-inhibitor (PDE-4) roflumilast (Daxas). Evaluation is based on two COPD specific questionnaires to assess the patient's health status over six months. During the study, lung function measurements such as spirometry will be conducted according to common medical standard. Daxas (tablet) will be administered once daily. The study will provide further data on the safety and tolerability of Daxas."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients diagnosed with severe COPD.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* severe COPD\n\nMain Exclusion Criteria:\n\n* Child pugh (classified B and C)'}, 'identificationModule': {'nctId': 'NCT01285167', 'acronym': 'DACOTA', 'briefTitle': 'Quality of Life in Daxas-treated Patients Older Than 18 Years With Severe Chronic Obstructive Pulmonary Disease (COPD) (DACOTA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Daxas for COPD Therapy (DACOTA)', 'orgStudyIdInfo': {'id': 'RO-2455-401-DE'}, 'secondaryIdInfos': [{'id': 'U1111-1136-8784', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'DACOTA', 'interventionNames': ['Drug: Daxas']}], 'interventions': [{'name': 'Daxas', 'type': 'DRUG', 'description': '500 microgram, oral, once daily as add-on therapy to existing therapy', 'armGroupLabels': ['DACOTA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59227', 'city': 'Ahlen', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 51.76338, 'lon': 7.8887}}, {'zip': '59229', 'city': 'Ahlen', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 51.76338, 'lon': 7.8887}}, {'zip': '35108', 'city': 'Allendorf', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 51.02995, 'lon': 8.67232}}, {'zip': '90584', 'city': 'Allersberg', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 49.25132, 'lon': 11.23659}}, {'zip': '57642', 'city': 'Alpenrod', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 50.63333, 'lon': 7.86667}}, {'zip': '58762', 'city': 'Altena', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 51.29472, 'lon': 7.67337}}, {'zip': '04600', 'city': 'Altenburg', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 50.98763, 'lon': 12.43684}}, {'zip': '63755', 'city': 'Alzenau in Unterfranken', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 50.0888, 'lon': 9.06455}}, {'zip': '55232', 'city': 'Alzey', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 49.74657, 'lon': 8.11513}}, {'zip': '92224', 'city': 'Amberg', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 49.44287, 'lon': 11.86267}}, {'zip': '17389', 'city': 'Anklam', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 53.85637, 'lon': 13.68965}}, {'zip': '09456', 'city': 'Annaberg-Buchholz', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 50.57953, 'lon': 13.00627}}, {'zip': '59821', 'city': 'Arnsberg', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 51.38333, 'lon': 8.08333}}, {'zip': '63739', 'city': 'Aschaffenburg', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 49.97704, 'lon': 9.15214}}, {'zip': '63743', 'city': 'Aschaffenburg', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 49.97704, 'lon': 9.15214}}, {'zip': '57439', 'city': 'Attendorn', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 51.12645, 'lon': 7.90333}}, {'zip': '85395', 'city': 'Attenkirchen', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 48.50526, 'lon': 11.76011}}, {'zip': '08209', 'city': 'Auerbach', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 50.51155, 'lon': 12.40083}}, {'zip': '86150', 'city': 'Augsburg', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '86156', 'city': 'Augsburg', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '71522', 'city': 'Backnang', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 48.94743, 'lon': 9.43718}}, {'zip': '18209', 'city': 'Bad Doberan', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 54.10712, 'lon': 11.90051}}, {'zip': '83093', 'city': 'Bad Endorf', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 47.90901, 'lon': 12.29795}}, {'zip': '49152', 'city': 'Bad Essen', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 52.31667, 'lon': 8.33333}}, {'zip': '16259', 'city': 'Bad Freienwalde', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 52.7873, 'lon': 14.0304}}, {'zip': '94072', 'city': 'Bad Füssing', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 48.351, 'lon': 13.312}}, {'zip': '53604', 'city': 'Bad Honnef', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 50.64336, 'lon': 7.2278}}, {'zip': '99947', 'city': 'Bad Langensalza', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 51.10771, 'lon': 10.646}}, {'zip': '33175', 'city': 'Bad Lippspringe', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 51.78333, 'lon': 8.81683}}, {'zip': '83435', 'city': 'Bad Reichenhall', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 47.72947, 'lon': 12.87819}}, {'zip': '32105', 'city': 'Bad Salzuflen', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 52.0862, 'lon': 8.74434}}, {'zip': '32108', 'city': 'Bad Salzuflen', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 52.0862, 'lon': 8.74434}}, {'zip': '36433', 'city': 'Bad Salzungen', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 50.81342, 'lon': 10.2361}}, {'zip': '65812', 'city': 'Bad Soden', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 50.28857, 'lon': 9.36404}}, {'zip': '63628', 'city': 'Bad Soden-Salmünster', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 50.27574, 'lon': 9.36705}}, {'zip': '99955', 'city': 'Bad Tennstedt', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 51.15447, 'lon': 10.83873}}, {'zip': '86825', 'city': 'Bad Wörishofen', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 48.00674, 'lon': 10.59666}}, {'zip': '39624', 'city': 'Badel', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 52.73253, 'lon': 11.31556}}, {'zip': '76530', 'city': 'Baden-Baden', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 48.7606, 'lon': 8.23975}}, {'zip': '96047', 'city': 'Bamberg', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 49.89873, 'lon': 10.90067}}, {'zip': '96049', 'city': 'Bamberg', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 49.89873, 'lon': 10.90067}}, {'zip': '22941', 'city': 'Bargteheide', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 53.72989, 'lon': 10.26739}}, {'zip': '34225', 'city': 'Baunatal', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 51.25182, 'lon': 9.40747}}, {'zip': '54538', 'city': 'Bausendorf', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 50.01667, 'lon': 7.0}}, {'zip': '02625', 'city': 'Bautzen', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 51.18035, 'lon': 14.43494}}, {'zip': '14547', 'city': 'Beelitz', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 52.23812, 'lon': 12.9714}}, {'zip': '64625', 'city': 'Bensheim', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 49.68369, 'lon': 8.61839}}, {'zip': '51429', 'city': 'Bergisch Gladbach', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 50.9856, 'lon': 7.13298}}, {'zip': '51465', 'city': 'Bergisch Gladbach', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 50.9856, 'lon': 7.13298}}, {'zip': '59192', 'city': 'Bergkamen', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 51.61633, 'lon': 7.64451}}, {'zip': '51702', 'city': 'Bergneustadt', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 51.02496, 'lon': 7.65599}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': 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'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13055', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13057', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13156', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13187', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13405', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13465', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13507', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13581', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14052', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14059', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '16321', 'city': 'Bernau', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 47.80018, 'lon': 8.0383}}, {'zip': '35216', 'city': 'Biedenkopf', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 50.91125, 'lon': 8.53016}}, {'zip': '33647', 'city': 'Bielefeld', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 52.03333, 'lon': 8.53333}}, {'zip': '74321', 'city': 'Bietigheim-Bissingen', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 48.94407, 'lon': 9.11755}}, {'zip': '06749', 'city': 'Bitterfeld-Wolfen', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 51.62355, 'lon': 12.32395}}, {'zip': '99444', 'city': 'Blankenhain', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 50.85993, 'lon': 11.3439}}, {'zip': '44866', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '44879', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '71149', 'city': 'Bondorf', 'country': 'Germany', 'facility': 'Nycomed 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