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.
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.145910
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.367911
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.127810
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 Raynaud's Phenomenon.
I am not taking any medications for blood pressure or heart rate.
I have fluid in my lungs.
I have gangrene in my fingers or toes.
My high blood pressure is not under control.
I have diabetes.
Treatment Details
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.
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
Loading ...
Who is running the clinical trial?
Virginia Commonwealth UniversityLead Sponsor
American Heart AssociationCollaborator
References
Multicentre randomised placebo-controlled trial of inhaled fluticasone propionate in patients with chronic obstructive pulmonary disease. International COPD Study Group. [2022]The efficacy of inhaled corticosteroids in the treatment of chronic obstructive pulmonary disease (COPD) remains controversial because of a lack of placebo-controlled studies. We compared the effect of inhaled fluticasone propionate with placebo in the treatment of patients with COPD.
[Long-term effect of inhaled budesonide in patients with mild to moderate chronic obstructive lung disease. The Osterbro Study]. [2006]We compared the effect of inhaled budesonide with placebo on decline in lung function and respiratory symptoms in a three-year study of patients with chronic obstructive pulmonary disease (COPD). We used a parallel-group, randomized, double-blind, placebo-controlled design, nested in an ongoing epidemiological survey. Patients were non-asthmatic subjects with a decreased ratio between forced expiratory volume in one second (FEV1) and vital capacity (VC); i.e., FEV1/VC
Efficacy and safety of tiotropium Respimat SMI in COPD in two 1-year randomized studies. [2022]Two 1-year studies evaluated the long-term efficacy and safety of tiotropium 5 or 10 microg versus placebo, inhaled via the Respimat Soft Mist Inhaler (SMI). The two studies were combined and had 4 co-primary endpoints (trough FEV(1) response, Mahler Transition Dyspnea Index [TDI] and St George's Respiratory Questionnaire scores all at week 48, and COPD exacerbations per patient-year). A total of 1990 patients with COPD participated (mean FEV(1): 1.09 L). The mean trough FEV(1) response of tiotropium 5 or 10 microg relative to placebo was 127 or 150 mL, respectively (both P
Tiotropium for treatment of stable COPD: a meta-analysis of clinically relevant outcomes. [2022]To systematically review recent evidence on the effectiveness of tiotropium versus placebo, ipratropium, and long-acting β(2) agonists on outcomes relevant to patients with stable COPD, including health-related quality of life, dyspnea, exacerbations and hospitalizations.
The combination of umeclidinium bromide and vilanterol in the management of chronic obstructive pulmonary disease: current evidence and future prospects. [2013]The defining feature of chronic obstructive pulmonary disease (COPD) is progressive airflow limitation that causes air trapping and hyperinflation. The increasing hyperinflation results in dyspnea along with associated inability to engage in the activities of daily living. The American Thoracic Society (ATS), European Respiratory Society (ERS) and Global Initiative for Chronic Obstructive Lung Disease (GOLD) treatment guidelines all place bronchodilators as the foundation of pharmacological management of COPD. In patients with moderate-to-very-severe respiratory impairment, adding regular treatment with one or more long-acting bronchodilators is recommended [long-acting β2-agonists (LABAs) or long-acting muscarinic antagonists (LAMAs)]. A growing body of evidence shows that LAMA and LABA co-administration is more effective than either drug class alone in managing stable COPD to improve lung function, symptoms and health status. Recently, new drug applications (NDAs) for a fixed-dose combination (FDC) of umeclidinium (UMEC), a LAMA, and vilanterol (VI), a LABA, at UMEC/VI doses of 125/25 and 62.5/25 µg have been submitted by sponsors to the US Food and Drug Administration (FDA) and to the European Medicines Agency (EMA). Thus, UMEC/VI has become the first FDC LAMA/LABA product that has reached a regulatory approval stage. Other LAMA/LABA once-daily combinations coming through development include FDCs of tiotropium and olodaterol, glycopyrronium and indacaterol, and twice-daily aclidinium and formoterol. The aim of this review is to explore currently available data for once-daily UMEC/VI in the context of the evolving standards of COPD management.
[Efficacy and Safety of Tiotropium Bromide in the Treatment of Chronic Obstructive Pulmonary Disease--a Multi-center Randomized Clinical Trial]. [2019]To investigate the efficacy and safety of domestic tiotropium inhalation capsule in patients with chronic obstructive pulmonary disease (COPD) with multi-center randomized clinical trial.
Efficacy and Safety of Glycopyrrolate/Formoterol Metered Dose Inhaler Formulated Using Co-Suspension Delivery Technology in Patients With COPD. [2022]Label="BACKGROUND" NlmCategory="BACKGROUND">Long-acting muscarinic antagonist (LAMA)/long-acting β2-agonist (LABA) combinations are a treatment option for patients with COPD who continue to have symptoms despite treatment with a LAMA or a LABA alone. The Efficacy and Safety of PT003, PT005, and PT001 in Subjects with Moderate-to-Very Severe COPD (PINNACLE-1) (NCT01854645) and the Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects with Moderate-to-Very Severe COPD (PINNACLE-2) (NCT01854658) trials investigated the efficacy and safety of a novel glycopyrrolate [GP]/formoterol [FF] 18/9.6-μg (GFF) metered dose inhaler (MDI) formulated using the Co-Suspension Delivery Technology in patients with moderate-to-very severe COPD.
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]Label="BACKGROUND">Long-acting muscarinic antagonist/long-acting β2-agonist combinations are recommended for patients whose chronic obstructive pulmonary disease (COPD) is not managed with monotherapy. We assessed the efficacy and safety of glycopyrrolate (GP)/formoterol fumarate (FF) fixed-dose combination delivered via a Co-Suspension™ Delivery Technology-based metered dose inhaler (MDI) (GFF MDI).
Comparative Efficacy of Once-Daily Umeclidinium/Vilanterol and Tiotropium/Olodaterol Therapy in Symptomatic Chronic Obstructive Pulmonary Disease: A Randomized Study. [2022]Label="INTRODUCTION">We report the results of the first direct comparison of the once-daily fixed-dose long-acting muscarinic antagonist/long-acting β2-agonist (LAMA/LABA) combinations umeclidinium/vilanterol (UMEC/VI) and tiotropium/olodaterol (TIO/OLO) in patients with COPD.
Real-life effectiveness of indacaterol-glycopyrronium after switching from tiotropium or salmeterol/fluticasone therapy in patients with symptomatic COPD: the POWER study. [2022]Label="PURPOSE" NlmCategory="OBJECTIVE">In contrast to randomized controlled trials (RCTs), changes in maintenance pharmacotherapy in clinical practice occur without a washout period. The Prospective cohort study for the real-life effectiveness evaluation of glycOpyrronium With indacatERol combination in the management of COPD in Canada (POWER) study evaluated the real-life effectiveness of indacaterol/glycopyrronium (IND/GLY) following a direct switch from a long-acting muscarinic antagonist (LAMA, tiotropium) or long-acting β2-agonist (LABA)/inhaled corticosteroid (ICS) maintenance treatment (salmeterol/fluticasone [SFC]).
Risks of budesonide/formoterol for the treatment of stable COPD: a meta-analysis. [2020]The aim of this study was to investigate the comparative risks of budesonide/formoterol, versus placebo or monotherapies, for the treatment of patients with stable COPD.