Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2026-02-27 @ 5:38 PM
Study NCT ID:
NCT03081650
Status:
UNKNOWN
Last Update Posted:
2017-03-16
First Post:
2017-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of the AIRVO Warm Humidifier as an Add on to 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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The study will be conducted as an open label, non-randomized trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-15', 'studyFirstSubmitDate': '2017-02-22', 'studyFirstSubmitQcDate': '2017-03-15', 'lastUpdatePostDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in number of hospitalizations warm humidification oxygen therapy and dry oxygen therapy.', 'timeFrame': 'baseline, 12 months', 'description': 'The change in number of hospitalizations compared to baseline data at 12 months.'}, {'measure': 'Change in the number of courses of antibiotic therapy compared to baseline data at 12 months', 'timeFrame': 'baseline, 12 months'}, {'measure': 'Change in the number of courses of corticosteroid therapy compared to baseline data at 12 months.', 'timeFrame': 'baseline, 12 months'}, {'measure': 'Change in the number of COPD medication therapy changes compared to baseline at 12 months.', 'timeFrame': 'baseline, 12 months'}], 'secondaryOutcomes': [{'measure': 'Change in Spirometry measured pulmonary function between humidification oxygen therapy and dry oxygen therapy at baseline, and 12 months.', 'timeFrame': 'baseline, 12 months', 'description': 'Change in Spirometry measured Pulmonary function test ( FEV1 and FEV1/FVC Forced vital capacity 1 (FEV1)- Volume forced expiration at 1.0, second in liters Forced Vital capacity - (FVC) Total amount of air in liters measured during a forced expiratory breath and peak expiratory flow) compared to baseline at 12 months'}, {'measure': 'The change in distance walked during a 6 minute walk test between humidification oxygen therapy and dry oxygen therapy at baseline, and 12 months.', 'timeFrame': 'baseline, 12 months', 'description': 'Change in 6 minute walk test (the distance walked in feet over a 6 minute period) compared to baseline at 12 months'}, {'measure': 'The change in the quality of life scores as measured by the Ferrans and Powers quality of life Index Pulmonary version III between humidification oxygen therapy and dry oxygen therapy at baseline, and 12 months.', 'timeFrame': 'baseline, 12 months', 'description': 'The change in the QOL measurements, (Ferrans and Powers Quality of Life Index Pulmonary Version -III, A two part 1 through 6 scaled survey, 1 very dissatisfied \\& 6 Very satisfied. The first part focuses on how satisfied you are with the area of your life and the second on how important that area of your life is to you. Each section is comprised of 36 questions.) compared to baseline at 12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COPD', 'Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '12166578', 'type': 'BACKGROUND', 'citation': 'Ringbaek TJ, Viskum K, Lange P. Does long-term oxygen therapy reduce hospitalisation in hypoxaemic chronic obstructive pulmonary disease? Eur Respir J. 2002 Jul;20(1):38-42. doi: 10.1183/09031936.02.00284202.'}, {'pmid': '6776858', 'type': 'BACKGROUND', 'citation': 'Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease: a clinical trial. Nocturnal Oxygen Therapy Trial Group. Ann Intern Med. 1980 Sep;93(3):391-8. doi: 10.7326/0003-4819-93-3-391.'}, {'pmid': '10145893', 'type': 'BACKGROUND', 'citation': 'Golar SD, Sutherland LL, Ford GT. Multipatient use of prefilled disposable oxygen humidifiers for up to 30 days: patient safety and cost analysis. Respir Care. 1993 Apr;38(4):343-7.'}, {'pmid': '16139158', 'type': 'BACKGROUND', 'citation': 'Yamashita K, Nishiyama T, Yokoyama T, Abe H, Manabe M. A comparison of the rate of bacterial contamination for prefilled disposable and reusable oxygen humidifiers. J Crit Care. 2005 Jun;20(2):172-5; discussion 175. doi: 10.1016/j.jcrc.2005.01.002.'}, {'pmid': '5059111', 'type': 'BACKGROUND', 'citation': 'Loew DA, Klein SR, Chalon J. Volume-controlled relative humidity using a constant-temperature water vaporizer. Anesthesiology. 1972 Feb;36(2):181-4. doi: 10.1097/00000542-197202000-00024. No abstract available.'}, {'pmid': '3229484', 'type': 'BACKGROUND', 'citation': 'Salah B, Dinh Xuan AT, Fouilladieu JL, Lockhart A, Regnard J. Nasal mucociliary transport in healthy subjects is slower when breathing dry air. Eur Respir J. 1988 Oct;1(9):852-5.'}, {'pmid': '18397537', 'type': 'BACKGROUND', 'citation': 'Miyamoto K, Nishimura M. Nasal dryness discomfort in individuals receiving dry oxygen via nasal cannula. Respir Care. 2008 Apr;53(4):503-4. No abstract available.'}, {'pmid': '27048871', 'type': 'BACKGROUND', 'citation': 'Franchini ML, Athanazio R, Amato-Lourenco LF, Carreirao-Neto W, Saldiva PH, Lorenzi-Filho G, Rubin BK, Nakagawa NK. Oxygen With Cold Bubble Humidification Is No Better Than Dry Oxygen in Preventing Mucus Dehydration, Decreased Mucociliary Clearance, and Decline in Pulmonary Function. Chest. 2016 Aug;150(2):407-14. doi: 10.1016/j.chest.2016.03.035. Epub 2016 Apr 2.'}, {'pmid': '20144858', 'type': 'BACKGROUND', 'citation': "Rea H, McAuley S, Jayaram L, Garrett J, Hockey H, Storey L, O'Donnell G, Haru L, Payton M, O'Donnell K. The clinical utility of long-term humidification therapy in chronic airway disease. Respir Med. 2010 Apr;104(4):525-33. doi: 10.1016/j.rmed.2009.12.016. Epub 2010 Feb 9."}, {'pmid': '21510031', 'type': 'BACKGROUND', 'citation': 'Wier LM, Elixhauser A, Pfuntner A, Au DH. Overview of Hospitalizations among Patients with COPD, 2008. 2011 Feb. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #106. Available from http://www.ncbi.nlm.nih.gov/books/NBK53969/'}], 'seeAlsoLinks': [{'url': 'http://www.nhlbi.nih.gov/health/dci/Diseases/Copd/copd_WhatIs.html.', 'label': 'What is COPD? National Heart Lung and Blood Institute: Diseases and Conditions Index. June 2010.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to show whether at home usage of the AIRVO warm humidifier can potentially reduce the number of exacerbations in patients with significant respiratory insufficiency. Eligible participants of the study must have a diagnosis of chronic obstructive pulmonary disease (COPD) stage II-IV..', 'detailedDescription': "SPECIFIC AIMS/OBJECTIVES To determine whether the patients with chronic respiratory sufficiency can benefit from the AIRVO warm humidifier by decreasing the number of exacerbations. Furthermore, to determine the efficacy of warm humidification oxygen therapy compared to dry oxygen therapy, in short-term and long-term treatment of patients with stage II-IV COPD.\n\nPrimary Objective:\n\nTo observer and compare the exacerbation frequency between the warm humidification oxygen therapy group and dry oxygen therapy group.\n\nSecondary Objective:\n\nCompare the number of exacerbation days, median time to first exacerbation, hospital readmissions, and antibiotic use pertaining to respiratory infections with the baseline values. Evaluate and compare the quality of life to the baseline measurements.\n\nSTUDY OVERVIEW\n\nMethods:\n\nThe study will be conducted as an open label, non-randomized trial. Patients will be assigned to AIRVO humidification if they meet all of the inclusion/exclusion criteria of the study. All of the study participants will have the AIRVO warm humidifier installed at their home as a stand alone unit or in addition to their current LTOT therapy. For the patients that are already on LTOT, the oxygen flow setting will be increased to 20-25 l/min, to the optimum flow by taking in consideration the patient's preference.\n\nData:\n\nData to be collected includes exacerbation frequency, number of exacerbation days, and time to first exacerbation, pulmonary functions test, antibiotic usage and Quality of Life assessment.\n\nDescription of AIRVO:\n\nThe AIRVO is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases. The AIRVO humidifier has adjustable flow setting for delivery of fully saturated breathing gases at 37°C, 100% humidity.\n\nFlow rates on the humidifier are adjustable between 10 and 60 L/min for this specific population (general is 2 -60 L/min). AIRVO humidifier is intended to be used in combination with medical oxygen supply. When coupled to a medical oxygen supply, the regulation of oxygen concentration is ensured, allowing for treatment of COPD patients with greater oxygen flow without risking an increased accumulation of carbon dioxide. The mixed gases, atmospheric air and with medical oxygen, pass through a humidification chamber with sterile water for humidification and heating. Breathing tubes are equipped with spiral wire, this aids with heating and ensures the uniform temperature and humidity is maintained. The air is supplied to the patients at 37°C, 100% humidity. \\[16\\]\n\nTreatment groups:\n\nARIVO:\n\nAll of the patients that will be Selected to participate in the study will be given an AIRVO humidifier by the study sponsor. Patients will be connected to and instructed in the use of the AIRVO. The total flow will be set at 20-25 L/min, exact flow rate will be dependent on the patient's preference. Optiflow oxygen catheter will be used to ensure against unpleasant sensation due to high flow and to avoid push back in the system.\n\nWhen acceptable flow rate has been established, it is recorded in the patient's folder. The patients is then instructed to use the AIRVO for a minimum eight (8) hour period, preferably at night. Using the humidifier for a longer period of time is allowed. The total number of hours the humidifier was operational will be recorded at the end of the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHave stage II-IV COPD diagnosis Understand and accept oral and written information in English Be capable of handling the AIRVO warm humidifier after instruction \\>18years of age\n\nExclusion Criteria:\n\n* Comorbidity (known malignant disease, terminal illness, dementia, uncontrolled mental illness)\n* Bronchiectasis without simultaneous COPD diagnosis\n* Treatment with BiPAP in the home\n* Affected level of consciousness\n* Smoking status change during study period\n* Inability to provided signed consent'}, 'identificationModule': {'nctId': 'NCT03081650', 'briefTitle': 'The Efficacy of the AIRVO Warm Humidifier as an Add on to Oxygen Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Lutheran Hospital, Indiana'}, 'officialTitle': 'The Efficacy of the AIRVO Warm Humidifier as an Add on to Oxygen Therapy as Well as Stand-alone Therapy in Patients With Respiratory Insufficiency', 'orgStudyIdInfo': {'id': '16-454'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prospective Open label', 'description': "All of the patients that will be Selected to participate in the study will be given an AIRVO humidifier by the study sponsor. Patients will be connected to and instructed in the use of the AIRVO. The total flow will be set at 20-25 L/min, exact flow rate will be dependent on the patient's preference. Optiflow oxygen catheter will be used to ensure against unpleasant sensation due to high flow and to avoid push back in the system.\n\nWhen acceptable flow rated has been established, it is recorded in the patient's folder. The patients is then instructed to use the AIRVO for a minimum eight (8) hour period, preferably at night. Using the humidifier for a longer period of time is allowed. The total number of hours the humidifier was operational will be recorded at the end of the study", 'interventionNames': ['Device: Airvo Humidifier']}], 'interventions': [{'name': 'Airvo Humidifier', 'type': 'DEVICE', 'armGroupLabels': ['Prospective Open label']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46804', 'city': 'Fort Wayne', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gordon Bokhart, Pharm D', 'role': 'CONTACT', 'email': 'gbokhart@lhn.net', 'phone': '260-435-7718'}, {'name': 'Lisa Burris, RRT, CPFT', 'role': 'CONTACT', 'email': 'lburris@lhn.net', 'phone': '260-435-7890'}, {'name': 'Eustace Fernandes, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lutheran hospital', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}], 'centralContacts': [{'name': 'Gordon Bokhart, Pharm D', 'role': 'CONTACT', 'email': 'gbokhart@lhn.net', 'phone': '260-435-7718'}, {'name': 'Lisa Burris, RRT, CFPT', 'role': 'CONTACT', 'email': 'lburris@lhn.net', 'phone': '260-435-7890'}], 'overallOfficials': [{'name': 'Eustace Fernandes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lutheran hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lutheran Hospital, Indiana', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fisher and Paykel Healthcare', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Eustice Fernandes MD', 'investigatorAffiliation': 'Lutheran Hospital, Indiana'}}}}