MitoQ for COPD

Overseen By Paula Rodriguez-Miguelez, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Virginia Commonwealth University

Must not be taking: Vasoactive medications

Disqualifiers: Heart disease, Diabetes, Hypertension, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

4 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether MitoQ, a special antioxidant targeting the mitochondria (the energy producers in cells), can improve heart health in people with chronic obstructive pulmonary disease (COPD). COPD can cause breathing difficulties and is linked to heart problems, possibly due to oxidative stress. Participants will take either MitoQ or a placebo (inactive pill) daily for six weeks. The trial seeks individuals clinically diagnosed with COPD at specific stages affecting breathing. As an Early Phase 1 trial, this research aims to understand how MitoQ works in people, offering participants the chance to be among the first to receive this new treatment.

Do I need to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on vasoactive medications, you would be excluded from participating.

Is there any evidence suggesting that MitoQ is likely to be safe for humans?

Research has shown that MitoQ is a special antioxidant targeting mitochondria, the tiny powerhouses inside cells, helping to protect them from damage. Although specific safety information for MitoQ in people with COPD is unavailable, it has been tested in other groups. For instance, one study involved healthy middle-aged men who took 20 mg daily, focusing on mitochondrial health and stress.

While these studies did not detail safety results, testing MitoQ in humans suggests earlier research found it generally safe. Since this trial is in its early stages, the main goal is to ensure MitoQ is well-tolerated, with careful monitoring for any side effects or issues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for COPD focus on managing symptoms and include bronchodilators and steroids to open airways and reduce inflammation. But MitoQ works differently, targeting oxidative stress at the cellular level. It uses a powerful antioxidant, specifically designed to penetrate mitochondria, which are the energy powerhouses of cells. Researchers are excited because this approach could potentially protect lung cells from damage in a way that current treatments do not, offering a novel avenue for managing COPD.

What evidence suggests that MitoQ might be an effective treatment for COPD?

Research shows that MitoQ, a special antioxidant targeting the energy centers of cells, might improve heart health in people with COPD by reducing harmful stress in the body. Earlier studies demonstrated MitoQ's potential to protect against damage from this stress, which is believed to contribute to heart problems. MitoQ focuses on the mitochondria, the cell's powerhouse, preventing damage there. It has also reduced inflammation and improved lung function in conditions similar to COPD. These early findings suggest that MitoQ might enhance heart health in COPD patients. Participants in this trial will receive either MitoQ or a placebo to further evaluate its effectiveness. ^{1 2 3 6 7}

Who Is on the Research Team?

Paula Rodriguez-Miguelez, PhD

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for adults with moderate to severe COPD (GOLD Stages II to IV). Participants must have a clinical diagnosis of COPD. They can't join if they have heart disease, are on vasoactive meds, have fluid in their lungs, gangrene, uncontrolled high blood pressure, Raynaud's Phenomenon, sleep apnea, a history of coagulation issues or diabetes.

Inclusion Criteria

I have been diagnosed with COPD.

My lung condition is moderate to very severe.

Exclusion Criteria

I have sleep apnea.

I have Raynaud's Phenomenon.

I have heart disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either MitoQ or placebo for 6 weeks

6 weeks

Baseline and end of treatment visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MitoQ
• Placebo

Trial Overview The study tests whether MitoQ—a mitochondrial-targeted antioxidant—can improve cardiovascular health in people with COPD. It compares the effects of MitoQ against a placebo (a substance with no therapeutic effect) to see if there's any benefit.

How Is the Trial Designed?

Group I: MitoQ Experimental Treatment 1 Intervention

Participants will take 1 pill each day for 6 weeks

Group II: Placebo Placebo Group 1 Intervention

Participants will take 1 pill each day for 6 weeks

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Published Research Related to This Trial

In a study involving 281 COPD patients, fluticasone propionate significantly reduced the severity of exacerbations compared to placebo, with 60% of patients experiencing moderate or severe exacerbations versus 86% in the placebo group (p<0.001).

Patients treated with fluticasone propionate showed significant improvements in lung function and symptoms, including increased peak expiratory flow and a greater 6-minute walking distance, while the treatment was well-tolerated with minimal adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicentre randomised placebo-controlled trial of inhaled fluticasone propionate in patients with chronic obstructive pulmonary disease. International COPD Study Group. Paggiaro, PL., Dahle, R., Bakran, I., et al.[2022]

The fixed-dose combination of glycopyrrolate and formoterol (GFF MDI) significantly improved lung function in patients with moderate-to-very severe COPD after 7 days of treatment, outperforming monocomponent inhalers and placebo.

Both doses of GFF MDI (72/9.6 μg and 36/9.6 μg) were well tolerated, indicating a favorable safety profile for this combination therapy in managing COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, seven-day study to assess the efficacy and safety of a glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler using novel Co-Suspension™ Delivery Technology in patients with moderate-to-very severe chronic obstructive pulmonary disease. Reisner, C., Fabbri, LM., Kerwin, EM., et al.[2022]

In a study involving 236 patients with COPD, the combination of umeclidinium/vilanterol (UMEC/VI) was found to be superior to tiotropium/olodaterol (TIO/OLO) in improving lung function, as measured by trough FEV1, after 8 weeks of treatment.

Both UMEC/VI and TIO/OLO had similar safety profiles, with adverse events occurring in 25% of the UMEC/VI group and 31% of the TIO/OLO group, indicating that UMEC/VI is an effective and safe option for managing COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Efficacy of Once-Daily Umeclidinium/Vilanterol and Tiotropium/Olodaterol Therapy in Symptomatic Chronic Obstructive Pulmonary Disease: A Randomized Study. Feldman, GJ., Sousa, AR., Lipson, DA., et al.[2022]

Tiotropium significantly improves health-related quality of life and reduces dyspnea in patients with stable COPD compared to both placebo and ipratropium, based on a review of 16 trials involving 16,301 patients.

Tiotropium also lowers the risk of exacerbations and related hospitalizations without increasing the likelihood of serious adverse events, although it does have a higher incidence of dry mouth compared to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tiotropium for treatment of stable COPD: a meta-analysis of clinically relevant outcomes. Yohannes, AM., Willgoss, TG., Vestbo, J.[2022]

In a clinical trial involving 220 patients with stable mild to moderate COPD, the tiotropium inhalation capsule showed significantly greater improvements in lung function (FEV1 and FVC) compared to ipratropium after four weeks of treatment.

Both treatments reduced COPD symptoms, but the tiotropium group experienced a more significant reduction, and the safety profiles were similar, with no significant difference in adverse events between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy and Safety of Tiotropium Bromide in the Treatment of Chronic Obstructive Pulmonary Disease--a Multi-center Randomized Clinical Trial]. Luo, Z., Liu, CT., Wu, CG., et al.[2019]

The GFF metered dose inhaler (MDI) significantly improved lung function in patients with moderate-to-very severe COPD compared to placebo and individual components, with increases in FEV1 of 150 mL and 103 mL in two separate trials involving over 3,700 patients.

The GFF MDI was well tolerated with no significant safety concerns, making it a promising additional treatment option for COPD patients who continue to experience symptoms despite existing therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Glycopyrrolate/Formoterol Metered Dose Inhaler Formulated Using Co-Suspension Delivery Technology in Patients With COPD. Martinez, FJ., Rabe, KF., Ferguson, GT., et al.[2022]

In a study involving 1990 patients with COPD, tiotropium (5 or 10 microg) significantly improved lung function (FEV1) compared to placebo, with increases of 127 mL and 150 mL respectively, and reduced COPD exacerbation rates by 22% and 27%.

Both doses of tiotropium also enhanced health-related quality of life, but the 5 microg dose had fewer anticholinergic side effects, making it a safer option while still providing effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tiotropium Respimat SMI in COPD in two 1-year randomized studies. Bateman, E., Singh, D., Smith, D., et al.[2022]

In the POWER study, patients with moderate-to-severe COPD who switched to the indacaterol/glycopyrronium (IND/GLY) combination experienced a significant improvement in lung function, with an average increase in trough FEV1 of 175 mL after 16 weeks.

The switch to IND/GLY also led to notable improvements in patient-reported outcomes, including dyspnea and quality of life, with no safety concerns reported, indicating that this treatment is both effective and well-tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-life effectiveness of indacaterol-glycopyrronium after switching from tiotropium or salmeterol/fluticasone therapy in patients with symptomatic COPD: the POWER study. Kaplan, A., Chapman, KR., Anees, SM., et al.[2022]

Long-acting bronchodilators, specifically the combination of umeclidinium (UMEC) and vilanterol (VI), are recommended as foundational treatments for managing chronic obstructive pulmonary disease (COPD), particularly in patients with moderate-to-very-severe respiratory impairment.

The co-administration of UMEC and VI has shown to be more effective than using either drug alone, improving lung function, symptoms, and overall health status, and it is the first fixed-dose combination of a LAMA and LABA to reach regulatory approval stages in the US and Europe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The combination of umeclidinium bromide and vilanterol in the management of chronic obstructive pulmonary disease: current evidence and future prospects. Feldman, GJ., Edin, A.[2013]

In a meta-analysis of 8 studies involving 9,254 patients with stable COPD, budesonide/formoterol combination therapy was found to significantly increase the risk of oral candidiasis and dysphonia compared to placebo and monotherapies.

However, the combination therapy did not show a higher risk of pneumonia or bronchitis compared to control treatments, indicating that while there are some increased risks, the overall safety profile regarding serious respiratory infections remains comparable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risks of budesonide/formoterol for the treatment of stable COPD: a meta-analysis. Tang, B., Wang, J., Luo, LL., et al.[2020]

In a three-year study involving 290 patients with chronic obstructive pulmonary disease (COPD), inhaled budesonide did not significantly reduce the decline in lung function compared to placebo, with an insignificant difference of only 3.1 ml/year in FEV1 decline.

Budesonide also showed no effect on respiratory symptoms or the frequency of exacerbations, raising questions about the effectiveness of long-term inhaled corticosteroids for treating mild to moderate COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Long-term effect of inhaled budesonide in patients with mild to moderate chronic obstructive lung disease. The Osterbro Study]. Vestbo, J., Sørensen, T., Lange, P., et al.[2006]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10135688/

Mitochondria-Targeted Antioxidants as a Therapeutic Strategy ... Antioxidants have been shown to protect against ROS-induced oxidative damage in COPD, by reducing ROS levels, reducing inflammation, and protecting against the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05605548

Study Details | NCT05605548 | Mitochondrial Derived ... MitoQ is a mitochondrial-targeted antioxidant that has shown promise in improving cardiovascular outcomes in similar populations. Thus the purpose of this study ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2667137922000091

Pharmacological significance of MitoQ in ameliorating ... MitoQ is a selective antioxidant that concentrates in the mitochondria and prevents oxidative damage to the mitochondria.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11194646/

MitoQ Alleviated PM2.5 Induced Pulmonary Epithelial Cells ... MitoQ restored the decreased mitochondrial dysfunction and dynamics disorder and inhibited activated mitochondrial-mediated apoptosis induced by PM 2.5.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S156757692033616X

Mitoquinone ameliorates cigarette smoke-induced airway ... MitoQ attenuates inflammation, mucus hypersecretion, and oxidative stress induced by CS. It may exert these effects in part by modulating mitochondrial ...

6. withpower.com withpower.com/trial/phase-lung-diseases-obstructive-10-2022-53beb

MitoQ for COPD · Info for Participants The provided research does not contain safety data for MitoQ or its variants (Mitoquinone mesylate, MitoQ10, MitoQuinone, MitoQuinol) in the treatment of COPD.

7. mitoq.com mitoq.com/pages/research?srsltid=AfmBOorKrxcpw6YBn9e_rBRXacT2KihoLfGMtvH_WegU2_gbYVBGfSrg

mitoquinol mesylate research studies & clinical trials This study compared the effects of 20 mg/day MitoQ and 200 mg/day CoQ10 on biomarkers of mitochondrial health and oxidative stress in healthy middle-aged men ( ...