Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-02-28 @ 10:35 PM
Study NCT ID:
NCT00611520
Status:
COMPLETED
Last Update Posted:
2011-01-28
First Post:
2008-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Symbicort in 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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64730}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'lastUpdateSubmitDate': '2011-01-27', 'studyFirstSubmitDate': '2008-01-29', 'studyFirstSubmitQcDate': '2008-02-08', 'lastUpdatePostDateStruct': {'date': '2011-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'secondaryOutcomes': [{'measure': 'to get further insight into the details of the use , dosage scheme and duration of treatment with budesonide /formoterol in this population'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['treatment of COPD', 'related to the budesonide/formoterole therapy in patients with COPD.'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'Under daily routine conditions and without any intervention by the sponsor regarding the selection of subjects, diagnostic procedures, therapeutic decisions (medicinal and non- medicinal therapy, dose, duration, etc.), routine assessments, the participating physicians (i.e. pneumologists and internists) are asked to document relevant data related to the budesonide/formoterole therapy in patients with COPD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with COPD treated with budesonide/formoterol\n\nExclusion Criteria:\n\n* limitations; possible risks; warnings; contraindications mentioned in the SPC.'}, 'identificationModule': {'nctId': 'NCT00611520', 'acronym': 'SYMBOL', 'briefTitle': 'Symbicort in Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Symbicort in Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': '1312005009'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients with COPD treated with budesonide/formoterol'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kai Richter, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical Department AstraZeneca Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr Kai Richter', 'oldOrganization': 'AstraZeneca Germany'}}}}