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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the idea that MitoQ for COPD is an effective treatment?

The available research does not provide any data on MitoQ for COPD. Instead, it discusses other treatments like inhaled corticosteroids, indacaterol-glycopyrronium, and glycopyrrolate/formoterol combinations for COPD. Without specific studies on MitoQ for COPD, we can't say if it's effective for this condition based on the information provided. ^{1 2 3 4 5}

What safety data is available for MitoQ in treating COPD?

The provided research does not contain safety data for MitoQ or its variants (Mitoquinone mesylate, MitoQ10, MitoQuinone, MitoQuinol) in the treatment of COPD. The studies focus on other treatments such as glycopyrrolate/formoterol, tiotropium, and budesonide/formoterol. ^{2 6 7 8 9}

Is the drug MitoQ a promising treatment for COPD?

The provided research articles do not mention MitoQ or its effects on COPD, so we cannot determine if MitoQ is a promising treatment for COPD based on this information. ^{1 4 7 10 11}

Research Team

Paula Rodriguez-Miguelez, PhD

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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 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]

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]

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 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]

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]

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]

References

1. England 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Glycopyrrolate/Formoterol Metered Dose Inhaler Formulated Using Co-Suspension Delivery Technology in Patients With COPD. [2022]

3. Denmark pubmed.ncbi.nlm.nih.gov

[Long-term effect of inhaled budesonide in patients with mild to moderate chronic obstructive lung disease. The Osterbro Study]. [2006]

4. New Zealand 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. [2022]

5. England 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. [2022]

6. China 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]. [2019]

7. United States 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. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tiotropium Respimat SMI in COPD in two 1-year randomized studies. [2022]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Risks of budesonide/formoterol for the treatment of stable COPD: a meta-analysis. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Tiotropium for treatment of stable COPD: a meta-analysis of clinically relevant outcomes. [2022]

11. England 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. [2013]