O2 Transport and Utilization in Health and Lung Disease

University of Massachusetts, Amherst

Status and phase: Withdrawn; Phase 1

Conditions: Tetrahydrobiopterin Deficiency; Oxidative Stress; COPD

Treatments: Drug: Tetrahydrobiopterin; Drug: Placebo oral tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04014712

2018-4815

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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0 participants in 2 patient groups, including a placebo group

acute BH4/Tetrahydrobiopterin treatment

Experimental group

Description:

Oral supplement, Pill, 10 mg/kg of body weight

Treatment:

Drug: Tetrahydrobiopterin

Placebo

Placebo Comparator group

Description:

Oral supplement, Pill, Placebo pill with inert excipient

Treatment:

Drug: Placebo oral tablet