Viewing Study NCT00722267

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Ignite Creation Date: 2025-12-25 @ 12:56 AM
Ignite Modification Date: 2025-12-26 @ 1:45 PM
Study NCT ID: NCT00722267
Status: COMPLETED
Last Update Posted: 2020-01-22
First Post: 2008-07-23
Is NOT Gene Therapy: True
Has Adverse Events: False
Brief Title: European Non-interventional Study in Chronic Obstructive Pulmonary Disease (COPD) Patients
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-21', 'studyFirstSubmitDate': '2008-07-23', 'studyFirstSubmitQcDate': '2008-07-23', 'lastUpdatePostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-07-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patient's perception of the variability of symptoms due to severe stable state COPD throughout the day, the week and the year", 'timeFrame': 'Once'}], 'secondaryOutcomes': [{'measure': "Impact of symptoms (and variability of symptoms) on the patient's morning & daily living activities and sleep quality.", 'timeFrame': 'Once'}, {'measure': 'Describe how patient use their COPD treatment', 'timeFrame': 'Once'}, {'measure': "Factors that may influence the patient's perception of symptom variability", 'timeFrame': 'Once'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['severe COPD', 'COPD symptoms', 'variability of symptoms', "patient's perception"], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'referencesModule': {'references': [{'pmid': '21115606', 'type': 'DERIVED', 'citation': 'Kessler R, Partridge MR, Miravitlles M, Cazzola M, Vogelmeier C, Leynaud D, Ostinelli J. Symptom variability in patients with severe COPD: a pan-European cross-sectional study. Eur Respir J. 2011 Feb;37(2):264-72. doi: 10.1183/09031936.00051110. Epub 2010 Nov 29.'}]}, 'descriptionModule': {'briefSummary': 'This study is investigating how patients with severe stable state COPD perceive the variability of their symptoms throughout the day, the week and the year; the impact of these variations on their daily activities or sleep quality and how they deal with their treatments. For this purpose patients will be asked to answer a questionnaire over the phone'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participating physicians (GPs and Respiratory physicians) will be asked to recruit 4 patients (on average). The first patients presenting for a consultation for any reason, who meet eligibility criteria, and give informed consent, should be enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatients with a diagnosis of COPD\n* FEV1\\<50% and FEV1/FVC\\<0.7 according to lung function data in medical records.\n* Smoker or ex-smoker \\> 10 pack-years\n* Informed consent obtained\n\nExclusion Criteria:\n\n* Ongoing exacerbation of COPD or within the previous 3 months\n* Any other significant respiratory disease (including asthma and allergic rhinitis)'}, 'identificationModule': {'nctId': 'NCT00722267', 'briefTitle': 'European Non-interventional Study in Chronic Obstructive Pulmonary Disease (COPD) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Patient Perception of Symptom Variability. A Cross-sectional Study of Patients With Severe COPD.', 'orgStudyIdInfo': {'id': 'NIS-REU-DUM-2007/1'}}, 'contactsLocationsModule': {'locations': [{'city': 'Baden', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 48.00543, 'lon': 16.23264}}, {'city': 'Feldbach', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 46.95306, 'lon': 15.88833}}, {'city': 'Feldkirch', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 47.23306, 'lon': 9.6}}, {'city': 'Güssing', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 47.05936, 'lon': 16.32431}}, {'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'city': 'Landeck', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 47.13988, 'lon': 10.56593}}, {'city': 'Linz', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'city': 'Linz-Urfahr', 'country': 'Austria', 'facility': 'Research Site'}, {'city': 'Neusiedl am See', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 47.94901, 'lon': 16.8417}}, {'city': 'Salzburg', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'city': 'Schlüsslberg', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 48.21861, 'lon': 13.87161}}, {'city': 'Steyr', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 48.04274, 'lon': 14.42127}}, {'city': 'Thalheim/Wels', 'country': 'Austria', 'facility': 'Research Site'}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Wels', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 48.16667, 'lon': 14.03333}}, {'city': 'Winden', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 48.28542, 'lon': 14.59345}}, {'city': 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