Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT04014712
Status:
WITHDRAWN
Last Update Posted:
2023-12-19
First Post:
2019-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
O2 Transport and Utilization in Health and Lung Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D010661', 'term': 'Phenylketonurias'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D020739', 'term': 'Brain Diseases, Metabolic, Inborn'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000592', 'term': 'Amino Acid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C003402', 'term': 'sapropterin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Unable to recruit due to COVID-19 pandemic', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-12', 'studyFirstSubmitDate': '2019-07-03', 'studyFirstSubmitQcDate': '2019-07-08', 'lastUpdatePostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mitochondrial function', 'timeFrame': '4 hours', 'description': 'PCr recovery kinetics'}, {'measure': 'intracellular PO2', 'timeFrame': '4 hours', 'description': 'Myoglobin oxygenation'}], 'secondaryOutcomes': [{'measure': 'systemic blood markers of oxidative stress', 'timeFrame': '4 hours', 'description': 'blood markers'}, {'measure': 'Peripheral Blood flow', 'timeFrame': '4 hours', 'description': 'Exercise Blood flow by Doppler Ultrasound'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BH4', 'Exercise', 'Mitochondria', 'Vascular function'], 'conditions': ['COPD', 'Tetrahydrobiopterin Deficiency', 'Oxidative Stress']}, 'descriptionModule': {'briefSummary': 'Skeletal muscle dysfunction is a frequent and clinically relevant systemic manifestation of Chronic Pulmonary Obstructive Disease (COPD), which is still poorly understood. Therefore, the focus of this study is on the role of a deficit in tetrahydrobiopterin and nitric oxide synthase uncoupling induced by chronic oxidative stress on metabolic and vascular abnormalities in skeletal muscle of patients suffering from COPD.', 'detailedDescription': 'The purpose of this study is to assess the efficacy of supplementation with tetrahydrobiopterin (BH4) for improving vascular and muscle function in patients with COPD and healthy controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All subjects must be between the age of 18 and 85 years;\n* For the COPD cohort, patients with a diagnosis of stable COPD (i.e., those not experiencing an acute exacerbation of symptoms) and spirometric evidence of airway obstruction (FEV1 \\<80% predicted, FEV/FVC\\<0.70);\n* Ability to perform motor tests;\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* uncontrolled hypertension;\n* hyperlipidemia;\n* recent exacerbation;\n* Major cardiovascular event procedure (\\<3 months);\n* Pregnancy\n* known significant hepatic, renal disease, active substance abuse\n* contraindication to MRI, claustrophobia'}, 'identificationModule': {'nctId': 'NCT04014712', 'briefTitle': 'O2 Transport and Utilization in Health and Lung Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Amherst'}, 'officialTitle': 'Role of Nitric Oxide Coupling in Muscle Dysfunction With COPD', 'orgStudyIdInfo': {'id': '2018-4815'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'acute BH4/Tetrahydrobiopterin treatment', 'description': 'Oral supplement, Pill, 10 mg/kg of body weight', 'interventionNames': ['Drug: Tetrahydrobiopterin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Oral supplement, Pill, Placebo pill with inert excipient', 'interventionNames': ['Drug: Placebo oral tablet']}], 'interventions': [{'name': 'Tetrahydrobiopterin', 'type': 'DRUG', 'description': 'Oral, Single dose', 'armGroupLabels': ['acute BH4/Tetrahydrobiopterin treatment']}, {'name': 'Placebo oral tablet', 'type': 'DRUG', 'description': 'Single dose', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01003', 'city': 'Amherst', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Institute of Applied Life Sciences', 'geoPoint': {'lat': 42.36723, 'lon': -72.51852}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': '6 months post-publication', 'ipdSharing': 'YES', 'accessCriteria': 'Within 6 months after the data have been published, and upon written request, a limited, de-identified, anonymized dataset will be created pursuant to the Data use Agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Amherst', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}