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

NCT05605548 | Terminated Early Phase 1 FDA Drug

• 2 other identifiers: HM20021976905812
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

MitoQ; vascular function; cardiovascular health; exercise intolerance; Mitochondria

Outcome Measures

Primary Outcomes (3)

• Change in vascular function

  Flow-mediated dilation will be used to measure vasodilation in the brachial artery

  Baseline and 6 weeks

• Change in Skeletal Muscle Oxygenation

  Near-infrared spectroscopy will be used to measure leg muscle oxygenation

  Baseline and 6 weeks

• Change in oxidative stress

  Blood draws will be taken to measure oxidative stress markers in the blood through electron paramagnetic resonance

  Baseline and 6 weeks

Secondary Outcomes (2)

• Change in arterial stiffness

  Baseline and 6 weeks

• Change in microvascular function

  Baseline and 6 weeks

Study Arms (2)

MitoQ

EXPERIMENTAL

Participants will take 1 pill each day for 6 weeks

Drug: MitoQ

Placebo

PLACEBO COMPARATOR

Participants will take 1 pill each day for 6 weeks

Other: Placebo

Interventions

MitoQ DRUG

MitoQ is a mitochondrial targeted antioxidant that can be obtained over-the-counter.

MitoQ

Placebo OTHER

A look-alike inactive substance, a "sugar pill"

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• American Heart Association: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

mitoquinone

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paula Rodriguez-Miguelez, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 4, 2022
• Study Start: February 16, 2023
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)