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

NCT ID: NCT05605548

Last Updated: 2025-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-16

Study Completion Date

2024-07-30

Brief Summary

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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

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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MitoQ

Participants will take 1 pill each day for 6 weeks

Group Type EXPERIMENTAL

MitoQ

Intervention Type DRUG

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

Placebo

Participants will take 1 pill each day for 6 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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MitoQ

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

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paula Rodriguez-Miguelez, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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905812

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HM20021976

Identifier Type: -

Identifier Source: org_study_id

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