Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT01365702
Status:
UNKNOWN
Last Update Posted:
2011-06-07
First Post:
2011-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tiotropium in Patients With Tuberculosis (TB) Destroyed Lung
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'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': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-06-06', 'studyFirstSubmitDate': '2011-05-31', 'studyFirstSubmitQcDate': '2011-06-02', 'lastUpdatePostDateStruct': {'date': '2011-06-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'St-George respiratory questionnaire(SGRQ)', 'timeFrame': '6 months after initiation of tiotropium once-daily inhalation'}], 'secondaryOutcomes': [{'measure': 'lung function', 'timeFrame': '6mo after initiation of tiotropium once-daily inhalation'}, {'measure': 'cough VAS', 'timeFrame': '6mo after initiation of tiotropium once-daily inhalation'}, {'measure': 'adverse reaction of tiotropium', 'timeFrame': '6 months after initiation of tiotropium once-daily inhalation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'tiotropium', 'tuberculous destroyed lung'], 'conditions': ['Lung Disease, Obstructive', 'Tuberculosis']}, 'descriptionModule': {'briefSummary': 'The aim of this study to evaluate clinical efficacy of tiotropium in patients with airflow obstruction due to Tuberculosis (TB) destroyed lung.', 'detailedDescription': 'Tuberculosis can cause lung parenchymal destruction, volume loss, secondary bronchiectasis. Patients with TB destroyed lung complain chronic respiratory symptoms, such as chronic cough, sputum, dyspnea, exercise intolerance, and acute exacerbations. Some of them have chronic airflow obstructions on pulmonary function tests, similar to those of smokers.\n\nPrevious large randomized controlled trials, targeting patients with smoking related moderate to severe COPD,demonstrated that tiotropium improved quality of life and respiratory symptom with tolerable long-term safety. The investigators want to evaluate whether tiotropium can improve chronic respiratory symptom,an lung function in patients with COPD due to TB destroyed lung.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with TB destroyed lung visiting Seoul National University Bundang Hospital Respiratory center for chronic respiratory symptoms will be screened for study participants. Among the patients, those with definite pulmonary TB histor with airflow obstruction on their PFT were entrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* previous pulmonary tuberculosis history\n* never smoker or light smoker (\\<10 pack-year)\n* destruction of lung parenchyme, lung volume loss,secondary bronchiectasis due to tuberculosis in chest radiographs or chest CT, confirmed by board-certificate radiologist\n* airflow obstruction confirmed by pulmonary function test, FEV1/FVC \\<70%\n\nExclusion Criteria:\n\n* patients do not agree with study enrollment\n* patients with active tuberculosis or current antituberculous medication\n* patients under chemotherapy or other immunosuppressant therapy such as glucocorticoid.\n* active infection such as pneumonia, tuberculosis\n* patients who are illiterate\n* patients with dementia\n* pregnant or to be pregnant\n* previous lung resection surgery history'}, 'identificationModule': {'nctId': 'NCT01365702', 'briefTitle': 'Tiotropium in Patients With Tuberculosis (TB) Destroyed Lung', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Clinical Efficacy of Tiotripium in Patients With Airflow Obstruction Due to TB Destroyed Lung', 'orgStudyIdInfo': {'id': 'SNUBH_TLD and spiriva'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tiotropium in TB destroyed lung'}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sei Won Lee, M.D.', 'role': 'CONTACT', 'email': 'seiwon@snubh.org', 'phone': '82-31-787-7053'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Sei Won Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical research center, Seoul National University Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Sei Won Lee/Assistant professor', 'oldOrganization': 'Department of Internal Medicine, Seoul National University Bundang Hospital'}}}}