Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-04 @ 10:18 AM
Study NCT ID:
NCT06767904
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-17
First Post:
2025-01-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Versus Demand-Based Oxygen in Patients With Fibrotic Interstitial Lung Disease and Chronic Obstructive Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2025-01-05', 'studyFirstSubmitQcDate': '2025-01-05', 'lastUpdatePostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lowest oxygen', 'timeFrame': 'At Baseline', 'description': 'difference in the lowest oxygen saturation between the two different oxygen delivery systems during a 6-min. walk test.'}], 'secondaryOutcomes': [{'measure': 'percentage of saturation <90%', 'timeFrame': 'At baseline', 'description': 'Percentage of time when oxygen levels fall below 90% during walk test.'}, {'measure': 'minutes of saturation <90%', 'timeFrame': 'At baseline', 'description': 'Number of minutes when saturation falls below 90% during walk test.'}, {'measure': 'minimum value of oxygen', 'timeFrame': 'At baseline', 'description': 'Minimum value of oxygen saturation during walk test'}, {'measure': 'Pulse rate', 'timeFrame': 'At baseline', 'description': 'Mean pulse rate during walk test'}, {'measure': 'Maximum pulse rate', 'timeFrame': 'At baseline', 'description': 'Maximum pulse rate during walk test'}, {'measure': 'Distance', 'timeFrame': 'At baseline', 'description': 'Difference in walk test distance'}, {'measure': 'time to recover', 'timeFrame': 'At baseline', 'description': 'The time taken to recover oxygen saturation after walk test to the level obtained at rest'}, {'measure': 'Maximal Borg scale', 'timeFrame': 'At baseline', 'description': 'Maximal rating of dyspnea on the Borg scale (Borg Rating of Percived exertion, range 0-10, where 10 is maximal breathing difficulty).'}, {'measure': 'Change Borg scale', 'timeFrame': 'At baseline', 'description': 'Change in dyspnea from rest to end of the walk test measured by the Borg scale. (Borg Rating of Percived exertion, range 0-10, where 10 is maximal breathing difficulty)'}, {'measure': 'Patient preference', 'timeFrame': 'At baseline', 'description': 'Patient preferences for the two different systems ("Which system do you prefer?"'}, {'measure': 'Comfort Likert scale', 'timeFrame': 'At baseline', 'description': 'Comfort measured by a Likert scale on a scale from 1-7 where 1 equals strongly disagree and 7 equals strongly agree. There is no unabbreviated scale title.'}, {'measure': 'Reliability Likert scale', 'timeFrame': 'At baseline', 'description': 'Reliability measured by a Likert scale on a scale from 1-7 where 1 equals strongly disagree and 7 equals strongly agree. There is no unabbreviated scale title.'}, {'measure': 'Semi structured qualitative interviews', 'timeFrame': 'After 3-6 months', 'description': "Semi-structured qualitative interviews about patients' view on the different oxygen delivery systems"}, {'measure': 'comfort and frequency use oxygen', 'timeFrame': 'After 3-6 months', 'description': 'Questions regarding the use of the oxygen delivery systems with respect to comfort and frequency of use'}, {'measure': 'Quality of life questionnaire score', 'timeFrame': 'After 3-6 months', 'description': 'Change on Quality of life questionnaires between baseline and three to six months'}, {'measure': 'Baseline Characteristics', 'timeFrame': 'After 3-6 months', 'description': 'Associations between baseline characteristics and effect of and patient views on oxygen delivery systems'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Interstitial Lung Disease', 'Chronic Obstructive Pulmonary Disease', 'Oxygen Therapy', 'Palliation'], 'conditions': ['Interstitial Lung Disease', 'Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '40379312', 'type': 'DERIVED', 'citation': 'Kronborg-White S, Jensen JH, Bendstrup E, Prior TS. Comparing the efficacy of exertional oxygen delivery by continuous versus demand-based flow systems during 6-minute walk test in patients with fibrotic interstitial lung disease and COPD in a hospital setting (OXYCODE): a protocol for a randomised trial. BMJ Open. 2025 May 16;15(5):e099664. doi: 10.1136/bmjopen-2025-099664.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this randomised clinical trial is to compare the efficacy of exertional oxygen delivery by continous versus demand-based flow systems in patients with fibrotic Interstitial lung disease and chronic obstructive pulmonary disease . The main questions it aim to answer:\n\nIs there a difference in lowest oxygen saturation? Is there a difference in saturation: time below \\<90%, pulse rate, distance and patient preferences ? It is a cross over study, so all patients will test both methods. Participants will perform 2 6-minute walk tests with the two different oxygen delivery systems.', 'detailedDescription': "The study design is a single center, randomized, open-label cross-over exploratory comparative study to investigate the efficacy of two different oxygen delivery systems. Patients with chronic obstructive Pulmonary disease or fibrotic Interstitial Lung Disease that during a six-minute walk test can walk at least 50 m and desaturate below 88%, can be included in the study. The participants are performing 2 6-minute walk tests, randomized to perform the test with oxygen bottles or portable concentrators first. Primary endpoint is the difference in the lowest oxygen saturation between the two systems. Secondary endpoints are amongst others: difference in percentage of time and number of minutes when oxygen falls below 90%, mean and maximum pulse rate, distance and time taken to recover during the 6-minute walk test and scores from questionnaires. After 3-6 months, semistructured interviews will be done to record participants' experiences of ambulatory oxygen therapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Verified diagnosis of fibrotic interstitial lung disease or chronic obstructive pulmonary disease\n* Desaturation \\< 88% during 6-minute walk test or currently receiving ambulatory oxygen by continous oxygen\n* Able to walk at least 50 meters during a 6-minute walk test\n* Self-reported stable respiratory symptoms in the previous 2 weeks\n* Cognitively able to understand and participate in the study\n* Written informed consent\n\nExclusion Criteria:\n\n* Any physical condition including paralysis, lower extremity pain, or other musculoskeletal problems limiting exercise performance\n* Unstable heart condition or symptomatic stenotic valve disease\n* Smoking during the previous 24 hours\n* Pregnant women\n* Anemia, Hb \\< 7.3 mmol/l (women) or \\< 8.3 mmol/l (men)\n* Non-invasive ventilation'}, 'identificationModule': {'nctId': 'NCT06767904', 'acronym': 'OXYODE', 'briefTitle': 'Continuous Versus Demand-Based Oxygen in Patients With Fibrotic Interstitial Lung Disease and Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'A Protocol for a Randomized Trial Comparing the Efficacy of Exertional Oxygen Delivery by Continuous Versus Demand-Based Flow Systems During Six-minute Walk Test in Patients With Fibrotic Interstitial Lung Disease and Chronic Obstructive Pulmonary Disease (OXYCODE)', 'orgStudyIdInfo': {'id': 'OXYCODE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Continous oxygen', 'description': 'Oxygen delivery by Continous Oxygen Bottles', 'interventionNames': ['Device: Continous Oxygen by Bottles']}, {'type': 'OTHER', 'label': 'Demand Based Oxygen', 'description': 'Oxygen Delivery by Demand Oxygen delivery system.', 'interventionNames': ['Device: Demand oxygen by Portable Concentrator']}], 'interventions': [{'name': 'Continous Oxygen by Bottles', 'type': 'DEVICE', 'description': 'Oxygen delivery by bottles giving a continous flow.', 'armGroupLabels': ['Continous oxygen']}, {'name': 'Demand oxygen by Portable Concentrator', 'type': 'DEVICE', 'description': 'Oxygen delivery by consentrators, giving oxygen only when inhaling.', 'armGroupLabels': ['Demand Based Oxygen']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sissel Kronborg-White, MD, PhD', 'role': 'CONTACT', 'email': 'siskro@rm.dk', 'phone': '004524978716'}], 'overallOfficials': [{'name': 'Sissel Kronborg-White, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Full access to the protocol, participants dataset and statistical codes will be granted on reasonable request for up to 5 years after the study has ended.', 'ipdSharing': 'YES', 'description': 'Full access to the protocol, participants dataset and statistical codes will be granted on reasonable request.', 'accessCriteria': 'Full access to the protocol, participants dataset and statistical codes will be granted on reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sissel Kronborg-White', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Pulmonologist', 'investigatorFullName': 'Sissel Kronborg-White', 'investigatorAffiliation': 'Aarhus University Hospital'}}}}