Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2026-02-25 @ 4:58 PM
Study NCT ID:
NCT02499718
Status:
UNKNOWN
Last Update Posted:
2015-07-16
First Post:
2015-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive Positive Pressure (NPPV ) for Severe Stable Chronic Obstructive Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}], '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'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 368}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-15', 'studyFirstSubmitDate': '2015-06-09', 'studyFirstSubmitQcDate': '2015-07-15', 'lastUpdatePostDateStruct': {'date': '2015-07-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severe Respiratory Insufficiency (SRI) Questionnaire', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Blood gas analysis', 'timeFrame': '1 year'}, {'measure': 'Pulmanory function', 'timeFrame': '1 year'}, {'measure': 'Baseline Dyspnea Index/Transition Dyspnea Index', 'timeFrame': '1 year'}, {'measure': 'Chromic Respiratory Questionnaire', 'timeFrame': '1 year'}, {'measure': 'Chronic Obstructive Pulmonary Disease (COPD) Assessment Test', 'timeFrame': '1 year'}, {'measure': '6 Minute-Walking Distance and Borg Score', 'timeFrame': '1 year'}, {'measure': 'The frequency of exacerbation', 'timeFrame': '1 year'}, {'measure': 'The frequency of readmission', 'timeFrame': '1 year'}, {'measure': 'The frequency of ICU readmission', 'timeFrame': '1 year'}, {'measure': 'survival rate', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Obstructive Pulmonary Disease', 'Non-invasive positive pressure ventilation', 'quality of life', 'long-term oxygen therapy'], 'conditions': ['Chronic Obstructive Pulmonary Disease', 'Hypercapnic Respiratory Failure']}, 'referencesModule': {'references': [{'pmid': '28851800', 'type': 'DERIVED', 'citation': 'Chen R, Guan L, Wu W, Yang Z, Li X, Luo Q, Liang Z, Wang F, Guo B, Huo Y, Yang Y, Zhou L. The Chinese version of the Severe Respiratory Insufficiency questionnaire for patients with chronic hypercapnic chronic obstructive pulmonary disease receiving non-invasive positive pressure ventilation. BMJ Open. 2017 Aug 28;7(8):e017712. doi: 10.1136/bmjopen-2017-017712.'}, {'pmid': '28490871', 'type': 'DERIVED', 'citation': 'Zhou L, Li X, Guan L, Chen J, Guo B, Wu W, Huo Y, Zhou Z, Liang Z, Zhou Y, Tan J, Chen X, Song Y, Chen R. Home noninvasive positive pressure ventilation with built-in software in stable hypercapnic COPD: a short-term prospective, multicenter, randomized, controlled trial. Int J Chron Obstruct Pulmon Dis. 2017 Apr 27;12:1279-1286. doi: 10.2147/COPD.S127540. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': 'Assessment of the effect and safety of noninvasive positive pressure ventilation for severe stable chronic obstructive pulmonary disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinically stable, hypercapnic GOLD stage IV COPD, aged 18 years or older, baseline arterial carbon dioxide pressure (PaCO2) of 6.7 kPa (50 mmHg) or higher and a pH higher than 7·35, measured after at least 1 h rest in a sitting position.\n\nExclusion Criteria:\n\n* thorax or the lung other than COPD\n* No smoking or Cigarette≤10/day\n* obesity with a bodymass index (BMI) ≥40 kg/m²\n* malignant co-morbidities,severe heart failure (New York Heart Association stage IV),unstable angina, and severe arrhythmias.'}, 'identificationModule': {'nctId': 'NCT02499718', 'briefTitle': 'Non-invasive Positive Pressure (NPPV ) for Severe Stable Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'OTHER', 'fullName': 'Guangzhou Institute of Respiratory Disease'}, 'officialTitle': 'Non-invasive Positive Pressure Ventilation for the Treatment of Severe Stable Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'GRID-201506'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Noninvasive ventilator', 'description': 'noninvasive positive pressure ventilation combined with long-term oxygen therapy for severe stable chronic obstructive pulmonary disease', 'interventionNames': ['Device: BiPAP mode']}, {'type': 'NO_INTERVENTION', 'label': 'LTOT', 'description': 'long-term oxygen therapy for severe stable chronic obstructive pulmonary disease'}], 'interventions': [{'name': 'BiPAP mode', 'type': 'DEVICE', 'description': 'Noninvasive ventilator', 'armGroupLabels': ['Noninvasive ventilator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chen Rongchang, Doctor', 'role': 'CONTACT', 'email': 'icelucy@126.com', 'phone': '+8613902273260'}], 'facility': 'Guangzhou Institute of Respiratory Disease', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Zhou LuQian, Doctor', 'role': 'CONTACT', 'email': 'zhlx09@163.com', 'phone': '+86-15622236759'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou Institute of Respiratory Disease', 'class': 'OTHER'}, 'collaborators': [{'name': 'Southern Medical University, China', 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Third Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': "Dongguan People's Hospital", 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Guangzhou Institute of Respiratory Disease', 'investigatorFullName': 'LuQian Zhou', 'investigatorAffiliation': 'Guangzhou Institute of Respiratory Disease'}}}}