Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2026-02-22 @ 4:14 PM
Study NCT ID:
NCT02093195
Status:
UNKNOWN
Last Update Posted:
2014-03-20
First Post:
2014-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Bosentan in the Treatment of Stable Severe Chronic Obstructive Pulmonary Disease Patients
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077300', 'term': 'Bosentan'}, {'id': 'D000069502', 'term': 'Budesonide, Formoterol Fumarate Drug Combination'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000068759', 'term': 'Formoterol Fumarate'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D019819', 'term': 'Budesonide'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'lastUpdateSubmitDate': '2014-03-18', 'studyFirstSubmitDate': '2014-03-18', 'studyFirstSubmitQcDate': '2014-03-18', 'lastUpdatePostDateStruct': {'date': '2014-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of COPD Exacerbation', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': '6-min-walk distance (6-MWD)', 'timeFrame': '12 months'}, {'measure': 'Lung Function', 'timeFrame': '12 months'}, {'measure': 'mMRC/CAT score', 'timeFrame': '12 months'}, {'measure': 'SGRQ score', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Treatment, COPD, bosentan'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'descriptionModule': {'briefSummary': 'Present treatment for chronic obstructive pulmonary disease (COPD) has a certain role in reducing COPD exacerbation and hospitalization, improving the life quality, and postponing the lung function decline. But for some patients with severe COPD, current treatment only partially alleviates the symptoms and has little role in the lung function decline. In this randomized, multicenter study, the investigators evaluate the safety and efficacy of bosentan in the treatment of grade Ⅲ or Ⅳ COPD patients with pulmonary hypertension detected by echocardiography. The primary endpoint is the frequency of COPD exacerbation, and the secondary endpoint includes changes of lung function, 6-min-walk distance (6-MWD), SGRQ score and mMRC/CAT score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 to 75\n* Gold Ⅲ or Ⅳ stable COPD\n* Pulmonary hypertension detected by echocardiography\n\nExclusion Criteria:\n\n* Acute exacerbation of chronic obstructive pulmonary disease\n* Untreated obstructive sleep apnea\n* Restrictive (total lung capacity\\<60% predicted) lung disease\n* Portal hypertension\n* Chronic liver disease\n* Transaminase increased to normal line more than 3 times; total bilirubin increased 2 times more than the upper limit of the normal value\n* Left-sided or unrepaired congenital heart disease\n* Patients with other serious heart diseases\n* Patients with 1, 2, 4 and 5 categories of pulmonary hypertension\n* Unable to complete the 6 minutes walk test\n* Patients receiving other endothelin receptor antagonists\n* No cooperation to complete'}, 'identificationModule': {'nctId': 'NCT02093195', 'acronym': 'BTCOPD', 'briefTitle': 'Study of Bosentan in the Treatment of Stable Severe Chronic Obstructive Pulmonary Disease Patients', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'Phase Ⅱ Study of Bosentan in the Treatment of Stable Severe Chronic Obstructive Pulmonary Disease Patients', 'orgStudyIdInfo': {'id': 'BTCOPD-2014226'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bosentan', 'description': 'Bosentan,125mg,po,bid combined with inhaled Symbicort turbuhaler, 320/9μg, bid.', 'interventionNames': ['Drug: Bosentan', 'Drug: Symbicort turbuhaler']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Inhaled Symbicort turbuhaler, 320/9μg, bid.', 'interventionNames': ['Drug: Symbicort turbuhaler']}], 'interventions': [{'name': 'Bosentan', 'type': 'DRUG', 'armGroupLabels': ['Bosentan']}, {'name': 'Symbicort turbuhaler', 'type': 'DRUG', 'armGroupLabels': ['Bosentan', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710004', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'YUAN LIU, MD', 'role': 'CONTACT', 'email': 'liuyuan@xjtu.edu.cn'}, {'name': 'YUAN LIU, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "The second affiliated hospital of xi'an jiaotong university", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xinpeng Han, MD', 'role': 'CONTACT', 'email': 'hxp0728@163.com', 'phone': '+86-29-84771135'}, {'name': 'Xinpeng Han, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The department of pulmonary and critical care medicine, Xijing hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '710038', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'yandong nan, MD', 'role': 'CONTACT', 'email': '13709205538@163.com'}, {'name': 'YANDONG NAN, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The department of pulmonary and critical care medicine, Tangdou hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '710064', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'ting liu, MD', 'role': 'CONTACT', 'phone': '18991938962'}, {'name': 'TING LIU, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "The first affiliated hospital of xi'an jiaotong university", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '710068', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'LINGBIN XU, MD', 'role': 'CONTACT', 'email': '18542705@qq.com'}, {'name': 'LINGBIN XU, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Shaanxi Provincial People'S Hospital", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Shengqing Li, MD, PhD', 'role': 'CONTACT', 'email': 'shengqingli@gmail.com', 'phone': '+86-29-84771132'}], 'overallOfficials': [{'name': 'Shengqing Li, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The department of pulmonary and critical care medicine, Xijing hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Chief Physician, Associate Professor', 'investigatorFullName': 'Shengqing Li', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}