Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT01481727
Status:
UNKNOWN
Last Update Posted:
2015-05-25
First Post:
2011-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exacerbation Prevention GOLD IV COPD With Non Invasive Mechanical Ventilation
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-22', 'studyFirstSubmitDate': '2011-10-20', 'studyFirstSubmitQcDate': '2011-11-28', 'lastUpdatePostDateStruct': {'date': '2015-05-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'acute exacerbations of Chronic Obstructive Pulmonary Disease frequency', 'timeFrame': '1 year', 'description': 'It will be calculated the exacerbation/year-patien rate and will be compared between groups'}, {'measure': 'acute exacerbation of chronic obstructive pulmonary disease severity', 'timeFrame': '1 year', 'description': 'It will be measured the rate of AECOPD with hospitalary and Intensive Care Unity requirement'}], 'secondaryOutcomes': [{'measure': 'lymphocyte subpopulations Th-1 and Th-17', 'timeFrame': '1 year', 'description': 'It will be measured the lymphocyte subpopulations like Th-1 and Th-17'}, {'measure': 'six-minute walking test', 'timeFrame': '1 year'}, {'measure': 'Forced expiratory volume in first second (FEV1) and forced expiratory capacity', 'timeFrame': '1 year'}, {'measure': 'Maximal inspiratory pressure and maximal expiratory pressure', 'timeFrame': '1 año'}, {'measure': 'gas exchange response (carbon and oxygen dioxide arterial pressure)', 'timeFrame': '1 year'}, {'measure': 'Health related quality of life', 'timeFrame': 'one year'}, {'measure': 'anxiety and depression measures (HAD and Beck Questionnaires)', 'timeFrame': 'one year'}, {'measure': 'echocardiographic parameters', 'timeFrame': 'one year'}, {'measure': 'survival', 'timeFrame': 'one year'}, {'measure': 'IL-1 and IL-6 cytokines', 'timeFrame': 'one year', 'description': 'it will be measured the level of interleukines 1 and 6(IL-1 and IL-6)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['acute exacerbation of COPD number', 'acute exacerbation of COPD severity'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '19213769', 'type': 'BACKGROUND', 'citation': "McEvoy RD, Pierce RJ, Hillman D, Esterman A, Ellis EE, Catcheside PG, O'Donoghue FJ, Barnes DJ, Grunstein RR; Australian trial of non-invasive Ventilation in Chronic Airflow Limitation (AVCAL) Study Group. Nocturnal non-invasive nasal ventilation in stable hypercapnic COPD: a randomised controlled trial. Thorax. 2009 Jul;64(7):561-6. doi: 10.1136/thx.2008.108274. Epub 2009 Feb 12."}, {'pmid': '12358325', 'type': 'BACKGROUND', 'citation': 'Clini E, Sturani C, Rossi A, Viaggi S, Corrado A, Donner CF, Ambrosino N; Rehabilitation and Chronic Care Study Group, Italian Association of Hospital Pulmonologists (AIPO). The Italian multicentre study on noninvasive ventilation in chronic obstructive pulmonary disease patients. Eur Respir J. 2002 Sep;20(3):529-38. doi: 10.1183/09031936.02.02162001.'}, {'pmid': '11115443', 'type': 'BACKGROUND', 'citation': 'Casanova C, Celli BR, Tost L, Soriano E, Abreu J, Velasco V, Santolaria F. Long-term controlled trial of nocturnal nasal positive pressure ventilation in patients with severe COPD. Chest. 2000 Dec;118(6):1582-90. doi: 10.1378/chest.118.6.1582.'}, {'pmid': '8756806', 'type': 'BACKGROUND', 'citation': 'Lin CC. Comparison between nocturnal nasal positive pressure ventilation combined with oxygen therapy and oxygen monotherapy in patients with severe COPD. Am J Respir Crit Care Med. 1996 Aug;154(2 Pt 1):353-8. doi: 10.1164/ajrccm.154.2.8756806.'}, {'pmid': '19277252', 'type': 'BACKGROUND', 'citation': 'Windisch W, Haenel M, Storre JH, Dreher M. High-intensity non-invasive positive pressure ventilation for stable hypercapnic COPD. Int J Med Sci. 2009;6(2):72-6. doi: 10.7150/ijms.6.72. Epub 2009 Feb 27.'}, {'pmid': '20388753', 'type': 'BACKGROUND', 'citation': 'Dreher M, Storre JH, Schmoor C, Windisch W. High-intensity versus low-intensity non-invasive ventilation in patients with stable hypercapnic COPD: a randomised crossover trial. Thorax. 2010 Apr;65(4):303-8. doi: 10.1136/thx.2009.124263.'}, {'pmid': '16100151', 'type': 'BACKGROUND', 'citation': 'Windisch W, Kostic S, Dreher M, Virchow JC Jr, Sorichter S. Outcome of patients with stable COPD receiving controlled noninvasive positive pressure ventilation aimed at a maximal reduction of Pa(CO2). Chest. 2005 Aug;128(2):657-62. doi: 10.1378/chest.128.2.657.'}, {'pmid': '17686094', 'type': 'BACKGROUND', 'citation': 'Budweiser S, Hitzl AP, Jorres RA, Heinemann F, Arzt M, Schroll S, Pfeifer M. Impact of noninvasive home ventilation on long-term survival in chronic hypercapnic COPD: a prospective observational study. Int J Clin Pract. 2007 Sep;61(9):1516-22. doi: 10.1111/j.1742-1241.2007.01427.x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of high-intensity non invasive mechanical ventilation (during one year to reduce the severity and frequency of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in patients with frequent AECOPD (frequent exacerbations defined more two or more AECOPD) and in GOLD IV stage (very severe COPD). The design is a randomised, double blind and controled with placebo (sham maneuver) clinical trial.', 'detailedDescription': 'Background:\n\n* There are many previous studies (no controlled trials or observational studies)that demonstrated minimal benefits (on gas exchange and marginal effect over exacerbations frequency) with the use of non invasive mechanical ventilation, in BiPAP modality with IPAP pressures \\<18H2ocm (low intensity), in COPD patients.\n* In subsequent years there were controled trials that concluded that there was no benefits with the use of non invasive mechanical ventilation on BiPAP mode in COPD patients ( It should be mentioned that in most trials were used low inspiratory pressure levels, that is called low-intensity non invasive mechanical ventilation).\n* However, there are other recent studies that described some benefits of high intensity Bilevel modality of non invasive mechanical ventilation (inspiratory pressures \\>18cmH2O) specially on gas exchange, quality of life and functional status.\n* There are some issues that do not yet have a clear answer like the optimal inspiratory pressure (IPAP) or the ventilation modality (BIPAP or other) to obtain the maximal benefit on COPD patients. Additionally, is not clear also if the use of non invasive mechanical ventilation on COPD patients helps to reduce the frequency and severity of acute exacerbations of COPD (AECOPD).\n\nThis study have some characteristics that are different to the previous reports:\n\n* The inclusion of patients with frequent exacerbations phenotype (and therefore worst prognosis patients)that there are no included in previous trials\n* The intervention maneuver that is bilevel modality of non invasive mechanical ventilation at hig-intensity pressure (\\>18H2Ocm and \\<24H2Ocm)\n* The use of placebo maneuver (CPAP "Sham")\n* The home titration in three phases, over a week\n* The long-term use of the intervention and sham maneuver'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical and spirometric diagnosis for COPD (FEV1/FVC \\<70%)\n* Clinical phenotype of frequent exacerbations\n* Must sign the informed consent\n* Former smokers\n* Stable COPD\n* FEV1 \\<35%\n* Optimal medical treatment\n\nExclusion Criteria:\n\n* OSAS diagnosis\n* Other indications for non invasive mechanical ventilation\n* Arterial pressure for dioxide carbon \\>45mmHg\n* Lung cancer\n* Impossibility for doing spirometry or going to the medical visits\n* Be included in another study'}, 'identificationModule': {'nctId': 'NCT01481727', 'briefTitle': 'Exacerbation Prevention GOLD IV COPD With Non Invasive Mechanical Ventilation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Institute of Respiratory Diseases, Mexico'}, 'officialTitle': "Exacerbation's Prevention in Patients With COPD in GOLD IV Stage (Very Severe) With Non Invasive Mechanical Ventilation", 'orgStudyIdInfo': {'id': 'C-18-10NIRD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'cpap sham', 'description': 'non invasive mechanical ventilation type cpap sham manoeuver', 'interventionNames': ['Device: BiPAP Pro 2, Phillips Respironics', 'Device: CPAP sham']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'high-intensity NIMV', 'description': 'Non-invasive mechanical ventilation, biPAP modality, with high-intensity IPAP (\\>18cmH2O)', 'interventionNames': ['Device: BiPAP Pro 2, Phillips Respironics']}], 'interventions': [{'name': 'BiPAP Pro 2, Phillips Respironics', 'type': 'DEVICE', 'otherNames': ['high intensity non invasive ventilation', 'high intensity bilevel'], 'description': 'mechanical ventilation type bilevel at high intensity (\\>18mmHg) for at least six hours, nocturnal ventilation.', 'armGroupLabels': ['cpap sham', 'high-intensity NIMV']}, {'name': 'CPAP sham', 'type': 'DEVICE', 'otherNames': ['placebo CPAP', 'sham non invasive ventilation'], 'description': 'CPAP sham maneuver (IPAP less or equal to 4cmH2O)', 'armGroupLabels': ['cpap sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14080', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'National Institute of Respiratory Diseases', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'RAUL HUMBERTO SANSORES MARTINEZ, MMS and MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Nacional de Enfermedades Respiratorias'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Respiratory Diseases, Mexico', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of COPD Clinic', 'investigatorFullName': 'Alejandra Ramirez Venegas', 'investigatorAffiliation': 'National Institute of Respiratory Diseases, Mexico'}}}}