NCT04014712

O2 Transport and Utilization in Health and Lung Disease

Role of Nitric Oxide Coupling in Muscle Dysfunction With COPD

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Massachusetts, Amherst · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• COPD
• Tetrahydrobiopterin Deficiency
• Oxidative Stress

Interventions

Type	Name	Description
DRUG	Tetrahydrobiopterin	Oral, Single dose
DRUG	Placebo oral tablet	Single dose

Timeline

• Start date: 2021-04-01
• Primary completion: 2022-08-01
• Completion: 2022-08-01
• First posted: 2019-07-10
• Last updated: 2023-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study