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.12345
What safety data is available for MitoQ in treating COPD?
Research Team
PR
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.
See 9 more
Treatment Details
Interventions
- MitoQ (Antioxidant)
- Placebo (Other)
Trial OverviewThe 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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MitoQExperimental Treatment1 Intervention
Participants will take 1 pill each day for 6 weeks
Group II: PlaceboPlacebo Group1 Intervention
Participants will take 1 pill each day for 6 weeks
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Virginia Commonwealth UniversityRichmond, VA
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Who Is Running the Clinical Trial?
Virginia Commonwealth University
Lead Sponsor
Trials
732
Patients Recruited
22,900,000+
American Heart Association
Collaborator
Trials
352
Patients Recruited
6,196,000+
Findings from Research
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]
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]
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]
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]
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]
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]
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]
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]
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]
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
Multicentre randomised placebo-controlled trial of inhaled fluticasone propionate in patients with chronic obstructive pulmonary disease. International COPD Study Group. [2022]
Efficacy and Safety of Glycopyrrolate/Formoterol Metered Dose Inhaler Formulated Using Co-Suspension Delivery Technology in Patients With COPD. [2022]
[Long-term effect of inhaled budesonide in patients with mild to moderate chronic obstructive lung disease. The Osterbro Study]. [2006]
Real-life effectiveness of indacaterol-glycopyrronium after switching from tiotropium or salmeterol/fluticasone therapy in patients with symptomatic COPD: the POWER study. [2022]
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]
[Efficacy and Safety of Tiotropium Bromide in the Treatment of Chronic Obstructive Pulmonary Disease--a Multi-center Randomized Clinical Trial]. [2019]
Comparative Efficacy of Once-Daily Umeclidinium/Vilanterol and Tiotropium/Olodaterol Therapy in Symptomatic Chronic Obstructive Pulmonary Disease: A Randomized Study. [2022]
Efficacy and safety of tiotropium Respimat SMI in COPD in two 1-year randomized studies. [2022]
Risks of budesonide/formoterol for the treatment of stable COPD: a meta-analysis. [2020]
Tiotropium for treatment of stable COPD: a meta-analysis of clinically relevant outcomes. [2022]
The combination of umeclidinium bromide and vilanterol in the management of chronic obstructive pulmonary disease: current evidence and future prospects. [2013]