O2 Transport and Utilization in Health and Lung Disease

COPD Clinical Trial

Official title:

Role of Nitric Oxide Coupling in Muscle Dysfunction With COPD

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04014712
• Other study ID #: 2018-4815
• Status: Withdrawn
• Phase: Phase 1
• Start date: April 2021
• Est. completion date: August 2022

Study information

• Verified date: December 2023
• Source: University of Massachusetts, Amherst
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Oxidative Stress
• Phenylketonurias
• Tetrahydrobiopterin Deficiency

Intervention

Drug:
• Tetrahydrobiopterin
Oral, Single dose
• Placebo oral tablet
Single dose

Locations

Country	Name	City	State
United States	Institute of Applied Life Sciences	Amherst	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Amherst

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mitochondrial function	PCr recovery kinetics	4 hours
Primary	intracellular PO2	Myoglobin oxygenation	4 hours
Secondary	systemic blood markers of oxidative stress	blood markers	4 hours
Secondary	Peripheral Blood flow	Exercise Blood flow by Doppler Ultrasound	4 hours