A Phase 1 interventional study of Tetrahydrobiopterin and Placebo oral tablet in COPD, Tetrahydrobiopterin Deficiency and Oxidative Stress, sponsored by University of Massachusetts, Amherst. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-19.
Sponsored by University of Massachusetts, Amherst · Phase 1, Interventional, and Basic science
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.
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.
183 studies on the registry are indexed under Phenylketonurias; 38 are open to participants now.
Browse Phenylketonurias studies →University of Massachusetts, Amherst is the lead sponsor of 45 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Oral supplement, Pill, 10 mg/kg of body weight
Drug: Tetrahydrobiopterin
Oral supplement, Pill, Placebo pill with inert excipient
Drug: Placebo oral tablet
Oral, Single dose
Single dose
Mitochondrial function
PCr recovery kinetics
Time frame: 4 hours
intracellular PO2
Myoglobin oxygenation
Time frame: 4 hours
systemic blood markers of oxidative stress
blood markers
Time frame: 4 hours
Peripheral Blood flow
Exercise Blood flow by Doppler Ultrasound
Time frame: 4 hours
Plan to share: Yes
Supporting information: Study protocol, Icf
No publications or documents are linked to this record.
This study is withdrawn, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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University of Massachusetts, Amherst