Mitochondrial Derived Reactive Oxygen Species on Cardiovascular Health in Chronic Obstructive Pulmonary Disease (COPD)

Early Phase 1

Terminated

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: Placebo; Drug: MitoQ

• Registration Number: NCT05605548
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

Cardiovascular health is a critical problem in patients with chronic obstructive pulmonary disease (COPD). Existing literature suggests oxidative stress from the mitochondria c driving some of the poor health outcomes in COPD. MitoQ is a mitochondrial-targeted antioxidant that has shown promise in improving cardiovascular outcomes in similar populations. Thus the purpose of this study is to test if MitoQ can improve cardiovascular health in COPD.

Detailed Description

In this study, a mitochondria-specific antioxidant will be compared to a placebo. Participants will be assigned randomly to receive either the antioxidant or the placebo for 6 weeks. A comprehensive assessment of cardiovascular health will be conducted before and after the administration of the supplement.

Study Timeline

• Study First Submitted: 2022-10-28
• Study First Submitted QC: 2022-10-28
• Study First Posted: 2022-11-04
• Study Start: 2023-02-16
• Primary Completion: 2024-07-30
• Study Completion: 2024-07-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Clinically diagnosed of COPD
• Global Initiative for obstructive lung disease (GOLD) Stages II to IV

Exclusion Criteria

• Forced Expiratory Volume in 1 second/ Functional Vital Capacity (FEV1/FVC) >0.7
• Heart Disease
• Diabetes
• Vasoactive medications
• Uncontrolled high blood pressure
• Fluid in lungs
• Sleep apnea
• Raynaud's Phenomenon
• Gangrene of the digits
• History of coagulation
• Pregnant women
• Children

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will take 1 pill each day for 6 weeks
MitoQ	MitoQ	Participants will take 1 pill each day for 6 weeks

Primary Outcome Measures

Name	Time	Method
Change in Skeletal Muscle Oxygenation	Baseline and 6 weeks	Near-infrared spectroscopy will be used to measure leg muscle oxygenation
Change in vascular function	Baseline and 6 weeks	Flow-mediated dilation will be used to measure vasodilation in the brachial artery
Change in oxidative stress	Baseline and 6 weeks	Blood draws will be taken to measure oxidative stress markers in the blood through electron paramagnetic resonance

Secondary Outcome Measures

Name	Time	Method
Change in arterial stiffness	Baseline and 6 weeks	Pulse wave velocity will be used to measure arterial stiffness.
Change in microvascular function	Baseline and 6 weeks	Microvascular function will be assessed using laser dopler imaging

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States