Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT01169727
Status:
COMPLETED
Last Update Posted:
2012-05-31
First Post:
2010-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational Study to Evaluate Health Status of Chronic Obstructive Pulmonary Disease (COPD) Patients in Response to Real-life Treatments in Thailand
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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 684}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-30', 'studyFirstSubmitDate': '2010-07-23', 'studyFirstSubmitQcDate': '2010-07-23', 'lastUpdatePostDateStruct': {'date': '2012-05-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in PEF and overall CCQ score', 'timeFrame': 'between the first visit and after 12 (plus or minus 1) weeks'}], 'secondaryOutcomes': [{'measure': 'Difference of the changes of PEF and overall CCQ score comparing between various treatments', 'timeFrame': 'between the first visit and after 12 (plus or minus 1) weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD and CCQ score', 'Changes in PEF,overall CCQ score'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate health status of uncontrolled Chronic Obstructive Pulmonary Disease (COPD) patients in response to treatments in clinical practice.', 'detailedDescription': 'MC MD'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '41 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care and Specialty care in 20 centers nationwide in Thailand', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provision of informed consent prior to any study specific procedures\n2. Male or non-pregnant female aged \\>40 years\n3. A clinical diagnosis of COPD with FEV1/ FVC \\<0.70 and require combination or modified therapy\n4. Smoke \\> 10 Pack Year\n\nExclusion Criteria:\n\n1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)\n2. Participation in a clinical study (precluding non-interventional study or registry) during the last 3 months'}, 'identificationModule': {'nctId': 'NCT01169727', 'briefTitle': 'Observational Study to Evaluate Health Status of Chronic Obstructive Pulmonary Disease (COPD) Patients in Response to Real-life Treatments in Thailand', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Observational Study to Evaluate Health Status of Chronic Obstructive Pulmonary Disease (COPD) Patients in Response to Real-life Treatments in Thailand', 'orgStudyIdInfo': {'id': 'NIS-RTH-DUM-2009/2'}}, 'contactsLocationsModule': {'locations': [{'city': 'SaiMai', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Research Site'}, {'city': 'Watana', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Research Site'}, {'city': 'Maung', 'state': 'Changwat Chanthaburi', 'country': 'Thailand', 'facility': 'Research Site'}, {'city': 'Maung', 'state': 'Changwat Chiang Rai', 'country': 'Thailand', 'facility': 'Research Site'}, {'city': 'Muang', 'state': 'Changwat Chon Buri', 'country': 'Thailand', 'facility': 'Research Site'}, {'city': 'Muang', 'state': 'Changwat Khon Kaen', 'country': 'Thailand', 'facility': 'Research Site'}, {'city': 'Ongkharak', 'state': 'Changwat Nakhon Nayok', 'country': 'Thailand', 'facility': 'Research Site', 'geoPoint': {'lat': 14.12117, 'lon': 101.00364}}, {'city': 'Maung', 'state': 'Changwat Nonthaburi', 'country': 'Thailand', 'facility': 'Research Site'}, {'city': 'Muang', 'state': 'Changwat Phitsanulok', 'country': 'Thailand', 'facility': 'Research Site'}, {'city': 'Maung', 'state': 'Changwat Rayong', 'country': 'Thailand', 'facility': 'Research Site'}, {'city': 'Hat Yai', 'state': 'Changwat Songkhla', 'country': 'Thailand', 'facility': 'Research Site', 'geoPoint': {'lat': 7.00836, 'lon': 100.47668}}, {'city': 'Song Phi Nong', 'state': 'Changwat Suphan Buri', 'country': 'Thailand', 'facility': 'Research Site', 'geoPoint': {'lat': 14.22408, 'lon': 100.02094}}, {'city': 'Maung', 'state': 'Changwat Trang', 'country': 'Thailand', 'facility': 'Research Site'}, {'city': 'Maung', 'state': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Research Site'}, {'city': 'Maung', 'state': 'Nakhon Sri Thammarat', 'country': 'Thailand', 'facility': 'Research Site'}, {'city': 'Maung', 'state': 'Nakhonratchasima', 'country': 'Thailand', 'facility': 'Research Site'}, {'city': 'Maung', 'state': 'Nakhonsawan', 'country': 'Thailand', 'facility': 'Research Site'}, {'city': 'Maung', 'state': 'Phuket', 'country': 'Thailand', 'facility': 'Research Site'}, {'city': 'Maung', 'state': 'Sakolnakorn', 'country': 'Thailand', 'facility': 'Research Site'}, {'city': 'Prannok, Bangkok', 'country': 'Thailand', 'facility': 'Research Site', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Assoc. Prof. Watchara Boonsawat', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Khon Kaen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}