Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT03584269
Status:
TERMINATED
Last Update Posted:
2021-02-10
First Post:
2018-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Innovation in NOn Invasive Ventilation in COPD Patients Treated by Long Term Oxygen Therapy
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'whyStopped': 'Recruiting difficulties', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-09', 'studyFirstSubmitDate': '2018-01-22', 'studyFirstSubmitQcDate': '2018-07-10', 'lastUpdatePostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nocturnal transcutaneous pressure CO2 (PtCO2)', 'timeFrame': '3 months', 'description': 'Measurement of nocturnal PtCO2 using the SenTec system'}], 'secondaryOutcomes': [{'measure': "Saint George's Respiratory Questionnaire", 'timeFrame': '3 months', 'description': 'Measure of quality of life'}, {'measure': 'FEV1', 'timeFrame': '3 months', 'description': 'Pulmonary function tests'}, {'measure': 'Vital capacity', 'timeFrame': '3 months', 'description': 'Pulmonary function tests'}, {'measure': 'PaO2', 'timeFrame': '3 months', 'description': 'Blood gases'}, {'measure': 'PaCO2', 'timeFrame': '3 months', 'description': 'Blood gases'}, {'measure': 'Steps per day', 'timeFrame': '3 months', 'description': 'Physical activity measured at home (one week)'}, {'measure': 'Time in supine and sitting positions', 'timeFrame': '3 months', 'description': 'Physical activity measured at home (one week)'}, {'measure': 'Energy expenditure', 'timeFrame': '3 months', 'description': 'Physical activity measured at home (one week)'}, {'measure': 'Heart Rate', 'timeFrame': '3 months', 'description': 'Physiological responses during the Semi paced 3-min Chair rise test'}, {'measure': 'SaO2', 'timeFrame': '3 months', 'description': 'Physiological responses during the Semi paced 3-min Chair rise test'}, {'measure': 'Dyspnea score', 'timeFrame': '3 months', 'description': 'Symptoms during the Semi paced 3-min Chair rise test'}, {'measure': 'Fatigue score', 'timeFrame': '3 months', 'description': 'Symptoms during the Semi paced 3-min Chair rise test'}, {'measure': 'Cholesterol', 'timeFrame': '3 months', 'description': 'Biological parameters'}, {'measure': 'Triglycerides', 'timeFrame': '3 months', 'description': 'Biological parameters'}, {'measure': 'Fasting Glucose', 'timeFrame': '3 months', 'description': 'Biological parameters'}, {'measure': 'CRPus', 'timeFrame': '3 months', 'description': 'Biological parameters'}, {'measure': 'HBA1c', 'timeFrame': '3 months', 'description': 'Biological parameters'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD', 'Oxygenation Long term', 'Non invasive Ventilation', 'Nocturnal Hypoventilation'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '27028990', 'type': 'RESULT', 'citation': 'Ko FW, Chan KP, Hui DS, Goddard JR, Shaw JG, Reid DW, Yang IA. Acute exacerbation of COPD. Respirology. 2016 Oct;21(7):1152-65. doi: 10.1111/resp.12780. Epub 2016 Mar 30.'}, {'pmid': '27698560', 'type': 'RESULT', 'citation': 'Dretzke J, Moore D, Dave C, Mukherjee R, Price MJ, Bayliss S, Wu X, Jordan RE, Turner AM. The effect of domiciliary noninvasive ventilation on clinical outcomes in stable and recently hospitalized patients with COPD: a systematic review and meta-analysis. Int J Chron Obstruct Pulmon Dis. 2016 Sep 16;11:2269-2286. doi: 10.2147/COPD.S104238. eCollection 2016.'}, {'pmid': '24912564', 'type': 'RESULT', 'citation': 'Borel JC, Pepin JL, Pison C, Vesin A, Gonzalez-Bermejo J, Court-Fortune I, Timsit JF. Long-term adherence with non-invasive ventilation improves prognosis in obese COPD patients. Respirology. 2014 Aug;19(6):857-65. doi: 10.1111/resp.12327. Epub 2014 Jun 9.'}, {'pmid': '25066329', 'type': 'RESULT', 'citation': 'Kohnlein T, Windisch W, Kohler D, Drabik A, Geiseler J, Hartl S, Karg O, Laier-Groeneveld G, Nava S, Schonhofer B, Schucher B, Wegscheider K, Criee CP, Welte T. Non-invasive positive pressure ventilation for the treatment of severe stable chronic obstructive pulmonary disease: a prospective, multicentre, randomised, controlled clinical trial. Lancet Respir Med. 2014 Sep;2(9):698-705. doi: 10.1016/S2213-2600(14)70153-5. Epub 2014 Jul 24.'}, {'pmid': '7633704', 'type': 'RESULT', 'citation': 'Meecham Jones DJ, Paul EA, Jones PW, Wedzicha JA. Nasal pressure support ventilation plus oxygen compared with oxygen therapy alone in hypercapnic COPD. Am J Respir Crit Care Med. 1995 Aug;152(2):538-44. doi: 10.1164/ajrccm.152.2.7633704.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the efficacy of non-invasive ventilation (NIV) on nocturnal hypoventilation in patients with chronic obstructive pulmonary disease (COPD) who are on long term oxygen therapy (LTOT) at home.', 'detailedDescription': 'This is a prospective, randomized, open labelled study. The primary outcome is nocturnal transcutaneous CO2 (PtCO2) after 3 months of non-invasive ventilation. Three hundred COPD patients on LTOT will be screened and assessed by pulmonary function tests, blood gases and nocturnal PtCO2 at their home. This will allow the determination of the prevalence of nocturnal hypoventilation in COPD patients on LTOT (a secondary outcome) and to select patients who meet the inclusion criteria for the RCT and randomization to NIV + LTOT or to continue LTOT alone (n=38). Patients will undergo the same assessments at the end of the three-month intervention period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic obstructive pulmonary disease (COPD)\n\n * on long term oxygen therapy (LTOT)\n * affiliated to French social security system or equivalent\n * informed consent signed\n\nExclusion Criteria:\n\n* Diurnal PtCO2 \\>55mmHg\n* Patient who has had an exacerbation of COPD requiring a change in management or treatment in the last 4 weeks prior to the inclusion visit.\n* Pregnant or breathfeeding women\n* Prisonners or persons who require protection by the law\n* Exclusion period from another study\n* Persons who, according to the investigator, are expected no to meet all study obligations'}, 'identificationModule': {'nctId': 'NCT03584269', 'acronym': 'INOV-LTOT', 'briefTitle': 'Innovation in NOn Invasive Ventilation in COPD Patients Treated by Long Term Oxygen Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Non Invasive Ventilation and Nocturnal Alveolar Hypoventilation in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated by Long Term Oxygen Therapy at Home', 'orgStudyIdInfo': {'id': '38RC17.117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NIV Device + LTOT', 'description': 'administration of ventilary support, without using an invasive artificial airway', 'interventionNames': ['Device: NIV Device + LTOT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LTOT', 'description': 'standard treatment, without NIV', 'interventionNames': ['Device: LTOT']}], 'interventions': [{'name': 'NIV Device + LTOT', 'type': 'DEVICE', 'description': 'Respiratory assistance by a facial mask without intubation or tracheotomy', 'armGroupLabels': ['NIV Device + LTOT']}, {'name': 'LTOT', 'type': 'DEVICE', 'description': 'Long term oxygenatory tyherapy without NIV', 'armGroupLabels': ['LTOT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38700', 'city': 'La Tronche', 'country': 'France', 'facility': 'University Hospital Grenoble', 'geoPoint': {'lat': 45.20507, 'lon': 5.74629}}], 'overallOfficials': [{'name': 'Jean-Louis Pépin, Pr, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Grenoble Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': 'AGIR à Dom', 'class': 'OTHER'}, {'name': 'ResMed', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}