Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-31 @ 6:07 AM
Study NCT ID:
NCT01180803
Status:
UNKNOWN
Last Update Posted:
2023-03-29
First Post:
2010-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Oxygen Therapy Delivered by Systems Using Oxygen-Saving Valves in COPD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-28', 'studyFirstSubmitDate': '2010-08-11', 'studyFirstSubmitQcDate': '2010-08-11', 'lastUpdatePostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'oxygen saturation during 6 minutes walking test', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'Walking distance during the 6 minutes walking test', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD - long term oxygenotherapy', 'COPD patients with respiratory failure'], 'conditions': ['LUNG DISEASES, OBSTRUCTIVE']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of oxygen therapy delivered by systems using oxygen-saving valves or not (continuous oxygen). We aim to determine if systems using oxygen-saving valves are equally effective as continuous oxygen delivery systems in reducing exercise-induced hypoxemia in patients with COPD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COPD on necessity of long term oxygen therapy\n* Able to give their written consent\n\nExclusion Criteria:\n\n* Unstable patients with COPD\n* Patients with restrictive respiratory disease\n* Patients with cardiac or neurologic disease contre-indicating the different evaluations'}, 'identificationModule': {'nctId': 'NCT01180803', 'briefTitle': 'Efficacy of Oxygen Therapy Delivered by Systems Using Oxygen-Saving Valves in COPD Patients', 'organization': {'class': 'OTHER', 'fullName': 'Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche'}, 'orgStudyIdInfo': {'id': 'EVAL- CLIN A00690-39'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'oxygen-saving valves', 'interventionNames': ['Device: pulse oxygen supplementation devices']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'continuous oxygen supplementation', 'interventionNames': ['Device: continuous oxygen']}], 'interventions': [{'name': 'pulse oxygen supplementation devices', 'type': 'DEVICE', 'otherNames': ['pulse group'], 'description': 'oxygen therapy delivered by systems using oxygen-saving valves', 'armGroupLabels': ['oxygen-saving valves']}, {'name': 'continuous oxygen', 'type': 'DEVICE', 'otherNames': ['continuous group'], 'description': 'oxygen therapy delivered by continuous liquid oxygen devices', 'armGroupLabels': ['continuous oxygen supplementation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75006', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jacqueline DELRIEU, Ph. D', 'role': 'CONTACT', 'email': 'delrieu@antadir.com', 'phone': '+33.1.56.81.40.60'}, {'name': 'Boris MELLONI, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fédération ANTADIR', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Boris MELLONI, Pr', 'role': 'CONTACT', 'email': 'melloni@unilim.fr', 'phone': '+33 1. 56. 81. 40. 60'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Project Manager', 'investigatorFullName': 'DELRIEU Jacqueline', 'investigatorAffiliation': 'Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche'}}}}