Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-27 @ 9:14 PM
Study NCT ID:
NCT01266395
Status:
COMPLETED
Last Update Posted:
2011-08-09
First Post:
2010-12-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Morning Symptoms in Clinical Control of Chronic Obstructive Pulmonary Disease (COPD)
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': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1268}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-08', 'studyFirstSubmitDate': '2010-12-21', 'studyFirstSubmitQcDate': '2010-12-23', 'lastUpdatePostDateStruct': {'date': '2011-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine if there are differences in the impact of COPD on patients according to the characteristics of the disease. To measure the impact of specific self-administered questionnaires used in COPD: CDLMQ, GCSQ and CCQ', 'timeFrame': 'Retrospective, (previous 24 months)', 'description': 'Capacity of Daily Living during the Morning Qustionnaire (CDLMQ), Global Chest Symptoms Questionnaire (GCSQ)and COPD Control Questionnaire (CCQ)'}], 'secondaryOutcomes': [{'measure': 'Assess comorbidities as a risk factor for frequent exacerbations', 'timeFrame': 'Retrospective, (previous 24 months)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['morning symptoms COPD'], 'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': 'Observational study to know the Impact of morning symptoms in clinical control of COPD patients. 1200 patients will be included by General practitioners (GPs) and pneumologists. Objective: establish if there are differences in the impact of COPD on daily activities and morning symptoms measured through questionnaires of daily life activity (Capacity of Daily Living during the Morning (CDLM), Global Chest Symptoms Questionnaire (GCSQ))'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'General Practitioners and pneumologist', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has signed informed consent form\n* Patients of both sexes,\\> 40 years.\n* Patients diagnosed with COPD according to global consensus on the definition, classification and management of the disease (GOLD) criteria:\n\n * post-bronchodilator forced expiratory volume in 1 s (FEV1) / forced vital capacity (FVC) \\<70%\n * post-bronchodilator FEV1 \\<80% (stage II, III and IV)\n\nExclusion Criteria:\n\n* Participating in an epidemiological study or clinical trial\n* Patient with other respiratory disease than COPD (eg bronchial asthma, cystic fibrosis, severe bronchiectasis, restrictive lung disease, cancer, etc.).\n* Patients with mild COPD: FEV1\\> 80%'}, 'identificationModule': {'nctId': 'NCT01266395', 'acronym': 'IMPAEPOC', 'briefTitle': 'Impact of Morning Symptoms in Clinical Control of Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Impact of Morning Symptoms in Clinical Control of COPD', 'orgStudyIdInfo': {'id': 'NIS-RES-DUM-2010/2'}}, 'contactsLocationsModule': {'locations': [{'city': 'Vitoria-Gasteiz', 'state': 'Alava', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}, {'city': 'Elda', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 38.47783, 'lon': -0.79157}}, {'city': 'Petrel', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Research Site', 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'responsibleParty': {'oldNameTitle': 'MC MD', 'oldOrganization': 'AstraZeneca'}}}}