Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-01-22 @ 6:54 AM
Study NCT ID:
NCT03688334
Status:
UNKNOWN
Last Update Posted:
2018-09-28
First Post:
2018-09-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Effects of Oxygen Supplementation Among IPF Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000388', 'term': 'Air'}], 'ancestors': [{'id': 'D001272', 'term': 'Atmosphere'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D008685', 'term': 'Meteorological Concepts'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-27', 'studyFirstSubmitDate': '2018-09-20', 'studyFirstSubmitQcDate': '2018-09-27', 'lastUpdatePostDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cerebral oxygenated hemoglobin', 'timeFrame': 'through study completion, an average of a year', 'description': 'The minimum value of cerebral oxygenated hemoglobin during steady state cardiopulmonary exercise testing'}, {'measure': 'Cardiac output', 'timeFrame': 'through study completion, an average of a year', 'description': 'The maximum value of cardiac output in L/min during steady state cardiopulmonary exercise testing'}], 'primaryOutcomes': [{'measure': 'Exercise duration', 'timeFrame': 'through study completion, an average of a year', 'description': 'Exercise duration (minutes) of steady state cardiopulmonary exercise testing until exhaustion'}], 'secondaryOutcomes': [{'measure': 'Dyspnea', 'timeFrame': 'through study completion, an average of a year', 'description': 'maximum dyspnea assessed with modified Borg dyspnea scale (range from 0: nothing at all to 10: maximum dyspnea), during steady state cardiopulmonary exercise testing'}, {'measure': 'Fatigue', 'timeFrame': 'through study completion, an average of a year', 'description': "maximum fatigue assessed by Borg's Rating of Perceived Exertion Scale (range from 6: no exertion to 20: maximal exertion), during steady state cardiopulmonary exercise testing"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Idiopathic Pulmonary Fibrosis']}, 'descriptionModule': {'briefSummary': "Idiopathic pulmonary fibrosis (IPF) is a disease characterised with significant morbidity and poor prognosis. Dyspnoea and impaired exercise capacity are very common manifestations of the disease, and result in significant impairment of patients' quality of life. Although hypoxemia is common among subjects with IPF, published data on the effects of supplementary oxygen therapy on specific clinical outcomes among these patients are currently few, while the existing data on the potential benefits of oxygen supplementation to treat exercise-induced hypoxemia, in this patient population, are even more controversial.\n\nBased on the aforementioned, the purpose of this prospective, cross-over clinical trial is to investigate the acute effects of supplemental oxygen administration on the: a) exercise capacity, b) severity of dyspnea, c) cerebral oxygenation, b) muscle oxygenation, and e) hemodynamic profile, as compared to delivery of medical air (sham oxygen), in a group of patients with IPF, without resting hypoxemia, during steady state cardiopulmonary exercise testing (CPET)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nStable IPF patients with no hospitalization, exacerbation or change in regular IPF medication during the last month, who do not present with resting hypoxemia, but manifest exercise induced hypoxemia\n\nExclusion Criteria:\n\n1. Major contraindications for CPET conduction\n2. Not provision of informed consent -'}, 'identificationModule': {'nctId': 'NCT03688334', 'briefTitle': 'Acute Effects of Oxygen Supplementation Among IPF Patients', 'organization': {'class': 'OTHER', 'fullName': 'George Papanicolaou Hospital'}, 'officialTitle': 'Acute Effects of Oxygen Supplementation During Exercise Among Patients With Idiopathic Pulmonary Fibrosis Without Resting Hypoxemia', 'orgStudyIdInfo': {'id': '804/2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'IPF patients', 'description': 'Supplementation of oxygen treatment (40% FiO2) during steady state cardiopulmonary exercise testing', 'interventionNames': ['Drug: Oxygen 40 %']}, {'type': 'SHAM_COMPARATOR', 'label': 'IPF patients (crossover)', 'description': 'Supplementation of medical air (sham Oxygen) during steady state cardiopulmonary exercise testing', 'interventionNames': ['Drug: Medical air (sham O2)']}], 'interventions': [{'name': 'Oxygen 40 %', 'type': 'DRUG', 'description': 'Oxygen supplementation (40%) via Venturi mask', 'armGroupLabels': ['IPF patients']}, {'name': 'Medical air (sham O2)', 'type': 'DRUG', 'description': 'Medical air supplementation via Venturi mask', 'armGroupLabels': ['IPF patients (crossover)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57010', 'city': 'Thessaloniki', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Afroditi Boutou, MD, MSc, PhD', 'role': 'CONTACT', 'email': 'afboutou@yahoo.com', 'phone': '00306946611433'}], 'facility': '"G. Papanikolaou" General Hospital', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'centralContacts': [{'name': 'Afroditi Boutou, MD, PhD, MSc', 'role': 'CONTACT', 'email': 'afboutou@yahoo.com', 'phone': '00306946611433'}], 'overallOfficials': [{'name': 'Aikaterini Markopoulou, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': '"G. Papanikolaou" General Hospital, Thessaloniki, Greece'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'George Papanicolaou Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant in Respiratory Medicine', 'investigatorFullName': 'Afroditi Boutou', 'investigatorAffiliation': 'George Papanicolaou Hospital'}}}}