Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-24 @ 3:28 PM
Study NCT ID:
NCT01146392
Status:
COMPLETED
Last Update Posted:
2014-06-18
First Post:
2010-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Investigation of the Past 10 Yrs Health Care for Primary Care Patients With Chronic Obstructive Pulmonary Disease
Sponsor:
Organization:
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': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27394}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-17', 'studyFirstSubmitDate': '2010-06-16', 'studyFirstSubmitQcDate': '2010-06-16', 'lastUpdatePostDateStruct': {'date': '2014-06-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Describe the development of COPD health care structure in primary care.', 'timeFrame': 'Data will be extracted from the medical records on one occassion, covering a period of one decade.'}], 'secondaryOutcomes': [{'measure': 'Describe the COPD population in primary care with special reference to treatment, co-morbidity and mortality during last decade.', 'timeFrame': 'Data will be extracted from the medical records on one occassion, covering a period of one decade.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Epidemiological', 'COPD health care', 'treatment in primary care'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '23495860', 'type': 'RESULT', 'citation': 'Larsson K, Janson C, Lisspers K, Jorgensen L, Stratelis G, Telg G, Stallberg B, Johansson G. Combination of budesonide/formoterol more effective than fluticasone/salmeterol in preventing exacerbations in chronic obstructive pulmonary disease: the PATHOS study. J Intern Med. 2013 Jun;273(6):584-94. doi: 10.1111/joim.12067. Epub 2013 Apr 1.'}, {'pmid': '24346825', 'type': 'RESULT', 'citation': 'Stallberg B, Janson C, Johansson G, Larsson K, Stratelis G, Telg G, Lisspers KH. Management, morbidity and mortality of COPD during an 11-year period: an observational retrospective epidemiological register study in Sweden (PATHOS). Prim Care Respir J. 2014 Mar;23(1):38-45. doi: 10.4104/pcrj.2013.00106.'}, {'pmid': '29922050', 'type': 'DERIVED', 'citation': 'Sandelin M, Mindus S, Thuresson M, Lisspers K, Stallberg B, Johansson G, Larsson K, Janson C. Factors associated with lung cancer in COPD patients. Int J Chron Obstruct Pulmon Dis. 2018 Jun 6;13:1833-1839. doi: 10.2147/COPD.S162484. eCollection 2018.'}, {'pmid': '25002194', 'type': 'DERIVED', 'citation': 'Lisspers K, Johansson G, Jansson C, Larsson K, Stratelis G, Hedegaard M, Stallberg B. Improvement in COPD management by access to asthma/COPD clinics in primary care: data from the observational PATHOS study. Respir Med. 2014 Sep;108(9):1345-54. doi: 10.1016/j.rmed.2014.06.002. Epub 2014 Jun 17.'}, {'pmid': '23719639', 'type': 'DERIVED', 'citation': 'Janson C, Larsson K, Lisspers KH, Stallberg B, Stratelis G, Goike H, Jorgensen L, Johansson G. Pneumonia and pneumonia related mortality in patients with COPD treated with fixed combinations of inhaled corticosteroid and long acting beta2 agonist: observational matched cohort study (PATHOS). BMJ. 2013 May 29;346:f3306. doi: 10.1136/bmj.f3306.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1072&filename=CSP-NIS-RSE-DUM-2010-1.pdf', 'label': 'Related Info'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1072&filename=CSP-NIS-RSE-DUM-2010-1.pdf', 'label': 'CSR-NIS-RSE-DUM-2010-1.pdf'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1072&filename=NCT01146392_CSR_Synopsis_120906.pdf', 'label': 'NIS-RSE-DUM-2010/1 Clinical Report Synopsis'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to describe COPD health care and to assess demographics, concurrent diseases and mortality and the use of pharmaceuticals for a chronic obstructive pulmonary disease (COPD) population in real life in primary care during the last ten years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible subjects are all COPD patients, found in medical records at the participating swedish primary care clinics. Primarily patients with diagnosis code J44 (ICD-10) stated in the medical record will be investigated. Patient data from the period 1 January 1999 - 31 December 2009 will be included in the observation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COPD diagnosis according to medical records.\n* Use of drugs prescribed for obstructive lung diseases'}, 'identificationModule': {'nctId': 'NCT01146392', 'acronym': 'PATHOS', 'briefTitle': 'An Investigation of the Past 10 Yrs Health Care for Primary Care Patients With Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Retrospective Epidemiological Study to Map Out Patients With Chronic Obstructive Pulmonary Disease (COPD) and Describe COPD Health Care in Real-Life Primary Care During the First Ten Years of the 21th Century', 'orgStudyIdInfo': {'id': 'NIS-RSE-DUM-2010/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Primary care patients with COPD diagnosis'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Docent Gunnar Johansson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uppsala University, Sweden'}, {'name': 'Kjell Larsson, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Karolinska Institutet'}, {'name': 'Georgios Stratelis, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca Nordics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}