Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2026-01-13 @ 7:41 AM
Study NCT ID:
NCT04840706
Status:
UNKNOWN
Last Update Posted:
2022-06-16
First Post:
2021-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-Label Prospective Study Comparing Long-Term Outcome With or Without HFNC in Patients With Stable Hypercapnic COPD
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': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 94}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-13', 'studyFirstSubmitDate': '2021-04-09', 'studyFirstSubmitQcDate': '2021-04-09', 'lastUpdatePostDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pCO2', 'timeFrame': '1 year', 'description': 'Improvement in daytime capillary pCO2 ≥ 0.5 kPa in the AirvoTM group compared to the standard care group'}, {'measure': 'Acute exacerbation rate', 'timeFrame': '1 year', 'description': 'decrease in acute exacerbation (moderate or severe) rate of COPD in AirvoTM group compared to the previous 12 months before entering the study and standard care group'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': 'The aims of the study are to compare long-term one-year outcome with or without AirvoTM in stabile hypercapnic COPD patients, who are non-compliant to NIV after an acute exacerbation of COPD.', 'detailedDescription': 'When compared to NIV, much less experience is available from clinical studies on HFNC therapy. Until now, few studies have investigated the effect of HFNC therapy on hypercapnic COPD patients and the number of patients recruited in these studies is limited. AirvoTM therapy could be good choice of treatment for those COPD patients that are not compliant to NIV but need treatment for hypercapnia in order to reduce COPD exacerbations and enhance QOL.The aims of the study are to compare long-term one-year outcome with or without AirvoTM in stabile hypercapnic COPD patients, who are non-compliant to NIV after an acute exacerbation of COPD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:COPD patients 1) with at least two acute moderate or severe exacerbations during past 12 months, 2) who at the follow-up visit one month after an acute severe exacerbation of COPD are hypercapnic (capillary pCO2 \\>6.5 kPa) and not willing to use NIV or have used it less than 4 h/d during the last month despite optimal settings prescribed by an experienced pulmonologist, or if a patient at the follow-up one month after a severe exacerbation is hypercapnic and is willing to try NIV (initiated at the follow-up visit, not at the ward), but then uses it less than 4h/d during the following month. Acute moderate (treated with short acting bronchodilators plus antibiotics and/or oral corticosteroids) and severe (patient requires hospitalization or visits the emergency room) exacerbations of COPD are defined according to the GINA Guidelines (GOLD 2019).\n\nExclusion Criteria: 1) OSA (diagnosed OSA or high suspicion OSA because of regular snoring, witnessed apneas and daytime sleepiness), 2) neuromuscular or chest wall disease, 3) BMI\\>35 kg/m2 or 4) a patient is not able to give his/her informed consent for the study.'}, 'identificationModule': {'nctId': 'NCT04840706', 'acronym': 'MyAirvo', 'briefTitle': 'Open-Label Prospective Study Comparing Long-Term Outcome With or Without HFNC in Patients With Stable Hypercapnic COPD', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'Open-Label Prospective Study Comparing Long-Term Outcome With or Without High-flow Nasal Cannula AirvoTM in Patients With Stable Hypercapnic COPD', 'orgStudyIdInfo': {'id': 'MyAirvo'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Airvo', 'description': 'Patients allocated to use Airvo device', 'interventionNames': ['Device: HFNC Airvo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Patients not using Airvo, standard care', 'interventionNames': ['Other: Standard care']}], 'interventions': [{'name': 'HFNC Airvo', 'type': 'DEVICE', 'description': 'HFNC device (Airvo) long-term use in in stabile hypercapnic COPD patients, who are non-compliant to NIV after an acute exacerbation of COPD', 'armGroupLabels': ['Airvo']}, {'name': 'Standard care', 'type': 'OTHER', 'description': 'No HFNC treatment', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20521', 'city': 'Turku', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Tarja a Saaresranta, MD', 'role': 'CONTACT', 'email': 'tasaare@utu.fi', 'phone': '0407401149'}], 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'centralContacts': [{'name': 'Tarja Saaresranta', 'role': 'CONTACT', 'email': 'tasaare@utu.fi', 'phone': '0407401149'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tarja Saaresranta', 'investigatorAffiliation': 'Turku University Hospital'}}}}