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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 January 2024 |
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Main ID: |
NCT04014712 |
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Date of registration:
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03/07/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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O2 Transport and Utilization in Health and Lung Disease
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Scientific title:
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Role of Nitric Oxide Coupling in Muscle Dysfunction With COPD |
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Date of first enrolment:
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April 2021 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT04014712 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Single (Participant).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All subjects must be between the age of 18 and 85 years;
- 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);
- Ability to perform motor tests;
- Ability to provide informed consent
Exclusion Criteria:
- uncontrolled hypertension;
- hyperlipidemia;
- recent exacerbation;
- Major cardiovascular event procedure (<3 months);
- Pregnancy
- known significant hepatic, renal disease, active substance abuse
- contraindication to MRI, claustrophobia
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Oxidative Stress
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Tetrahydrobiopterin Deficiency
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COPD
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Intervention(s)
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Drug: Placebo oral tablet
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Drug: Tetrahydrobiopterin
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Primary Outcome(s)
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Mitochondrial function
[Time Frame: 4 hours]
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intracellular PO2
[Time Frame: 4 hours]
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Secondary Outcome(s)
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Peripheral Blood flow
[Time Frame: 4 hours]
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systemic blood markers of oxidative stress
[Time Frame: 4 hours]
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Secondary ID(s)
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2018-4815
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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