Chronic Obstructive Pulmonary DiseaseEarly Phase 1NCT05605548
Mitochondrial Derived Reactive Oxygen Species on Cardiovascular Health in Chronic Obstructive Pulmonary Disease (COPD)
A Early Phase 1 study testing MitoQ in people with Chronic Obstructive Pulmonary Disease, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- MitoQ
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2023to 30 Jul 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically diagnosed of COPD
- Global Initiative for obstructive lung disease (GOLD) Stages II to IV
Who cannot join
- 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
Show all 12Show fewer
- Sleep apnea
- Raynaud's Phenomenon
- Gangrene of the digits
- History of coagulation
- Pregnant women
- Children
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: The Influence of Mitochondrial Derived Reactive Oxygen Species on Cardiovascular Health in Patients With Chronic Obstructive Pulmonary Disease
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- MitoQ, Placebo
- Keywords
- MitoQ, vascular function, cardiovascular health, exercise intolerance, Mitochondria
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitoQDrug
MitoQ is a mitochondrial targeted antioxidant that can be obtained over-the-counter.
PlaceboOther
A look-alike inactive substance, a "sugar pill"
| Study group | Role | What they receive |
|---|---|---|
| MitoQ | Experimental | Participants will take 1 pill each day for 6 weeks Receives: Drug: MitoQ |
| Placebo | Placebo comparator | Participants will take 1 pill each day for 6 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vascular function
Flow-mediated dilation will be used to measure vasodilation in the brachial artery
Measured: Baseline and 6 weeks
Change in Skeletal Muscle Oxygenation
Near-infrared spectroscopy will be used to measure leg muscle oxygenation
Measured: 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
Measured: Baseline and 6 weeks
Secondary outcomes (2)
Change in arterial stiffness
Pulse wave velocity will be used to measure arterial stiffness.
Measured: Baseline and 6 weeks
Change in microvascular function
Microvascular function will be assessed using laser dopler imaging
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start16 Feb 2023
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Why it stopped: Funding was inconsistent and the Post-Doc left before the project ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Paula Rodriguez-Miguelez, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605548
- Sponsor's protocol ID
- HM20021976
- Other IDs
- 905812
- Status last verified
- Feb 2025
- First submitted
- 28 Oct 2022
- Last updated
- 27 Feb 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Mitochondrial Derived Reactive Oxygen Species on Cardiovascular Health in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05605548
- Acronym / sponsor ID
- HM20021976
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- MitoQ, vascular function, cardiovascular health, exercise intolerance, Mitochondria
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding was inconsistent and the Post-Doc left before the project ended
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 4 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MitoQ | Experimental | Drug: MitoQParticipants will take 1 pill each day for 6 weeks |
| Placebo | Placebo comparator | Other: PlaceboParticipants will take 1 pill each day for 6 weeks |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinically diagnosed of COPD
- Global Initiative for obstructive lung disease (GOLD) Stages II to IV
Key exclusion criteria (12 listed)
- Forced Expiratory Volume in 1 second/ Functional Vital Capacity (FEV1/FVC) >0.7
- Heart Disease
- Diabetes
- Vasoactive medications
- Uncontrolled high blood pressure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MitoQMitoQ is a mitochondrial targeted antioxidant that can be obtained over-the-counter. | Drug | MitoQ |
| PlaceboA look-alike inactive substance, a "sugar pill" | Other | Placebo |
Primary outcome
Change in vascular function
Time frame: Baseline and 6 weeks
Flow-mediated dilation will be used to measure vasodilation in the brachial artery
Change in Skeletal Muscle Oxygenation
Time frame: Baseline and 6 weeks
Near-infrared spectroscopy will be used to measure leg muscle oxygenation
Change in oxidative stress
Time frame: Baseline and 6 weeks
Blood draws will be taken to measure oxidative stress markers in the blood through electron paramagnetic resonance
2 secondary outcomes
Change in arterial stiffness
Time frame: Baseline and 6 weeks
Change in microvascular function
Time frame: Baseline and 6 weeks
Results and safety
The study was stopped early (reason given: Funding was inconsistent and the Post-Doc left before the project ended). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula Rodriguez-Miguelez, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing MitoQ in people with Chronic Obstructive Pulmonary Disease, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Funding was inconsistent and the Post-Doc left before the project ended). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in vascular function (time frame: Baseline and 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.