Ensayos clínicos

We hypothesize that supplementation with L-carnitine that is available both as an FDA-approved therapy for primary carnitine deficiency, as well as widely available as an over-the-counter ergogenic aid will improve wellbeing and function measured by questionnaires in patient with chronic obstructive pulmonary disease (COPD). We further hypothesize based on our review of literature that addition of health coaching (HC) to L-carnitine will yield greater gains.

The purpose of this study is to develop a mindful breathing module to an already effective and developed home based rehabilitation program for guiding COPD patients in a mindful breathing practice and further palliate breathlessness and anxiety.

The purpose of this study is to assess the safety and effectiveness of  PT009 compared with PT005 for the prevention of moderate to very severe episodes of worsening COPD and lung function.

Regular physical activity has been found to be important in maintaining health and well-being in people with COPD. The purpose of this study is to test new technology and health coaching aimed to help people with COPD become more physically active in their daily lives.

The purpose of this study is to test new technology and health coaching aimed to help people with COPD become more physically active in their daily lives.

The primary purpose of this study is to evaluate the effectiveness of dupilumab administered every 2 weeks in patients with moderate-or severe Chronic Obstructive Pulmonary Disease (COPD) as measured by - Annualized rate of acute moderate and severe COPD exacerbation (AECOPD).

This is a multi-center, randomized, placebo-controlled, double-blind, parallel group trial evaluating mepolizumab 100 mg against placebo given every 4 weeks through subcutaneous (SC) injection.

In severe COPD patients, sputum eosinophils levels are elevated similar as those seen in severe asthmatics. It is hypothesized that the reduction of eosinophils with mepolizumab in COPD patients would translate into a reduction of COPD exacerbations. The study will determine the reduction in exacerbations in subjects who are above and below the baseline blood eosinophil count of at least 150 cells/microlitres. The study will evaluate the efficacy and safety of mepolizumab on the frequency of moderate ...

This study aims to expand the limited scientific knowledge of determinants of patient activation level of people living with chronic obstructive pulmonary disease (COPD) in the United States.

The investigators' proposed study is a randomized controlled trial that will prospectively examine the effect of a multicomponent intervention on the rate of hospitalizations, daily physical activity, self efficacy and health status in patients who have COPD and have been hospitalized because of a COPD exacerbation.

In the study, a convenience sample of patients recently hospitalized for a COPD exacerbation, who meet the selection criteria and agree to participate will be randomized to receive one of the following at the time of hospital discharge: (1) the current standard of care plus a multicomponent intervention (counselor + pulmonary rehabilitation) or (2) the ...

As part of the long-term goal of successfully implementing tissue regeneration strategies in an individualized manner for patients with thoracic diseases including, but not limited to: cystic fibrosis, pulmonary fibrosis and pulmonary hypertension, the investigators will assess the feasibility of collecting skin biopsies from patients undergoing surgery for thoracic disease, culturing skin fibroblasts from the biopsy, and reprogramming these skin fibroblasts into induced pluripotent cells.

The purpose of this study is to determine the effects of daily simvastatin, on the frequency of exacerbations of chronic obstructive lung disease (COPD) in patients with moderate to severe COPD who are prone to exacerbations and do not have other indications for statin treatment.

To establish the feasibility of a tool that monitors and motivates people with COPD to complete training in mindful pursed-lip breathing to enhance pulmonary rehabilitation at home.

The study evaluates the efficacy of fluticasone furoate/umeclidinium bromide/vilanterol (FF/UMEC/VI) to reduce the annual rate of moderate and severe exacerbations compared with dual therapy of FF/VI or UMEC/VI in subjects with COPD. Published studies which assessed the use of an 'open' triple therapy (use of Inhaled Corticosteroid [ICS]/ Long-acting Muscarinic Receptor Antagonists [LAMA])/ Long Acting Beta-Agonist [LABA] delivered via multiple inhalers) in moderate-severe COPD patients, reported improvements in lung function, Health Related Quality of Life (HRQoL), hospitalization rates and rescue medication use, compared to dual therapy (ICS/LABA) or LAMA alone. These studies have also shown similar safety profile with dual ...

The purpose of this study is to assess the effect of metoprolol for patients who have moderate to severe COPD, measuring the time to first acute exacerbation (episode of worsening), the rates and severity of exacerbations, any cardiovascular events, all-causes of death, lung function, difficulty breathing, quality of life and any metoprolol-related side effects.

The purpose of this study is to explore the benefit of Health Coaching on patients with COPD versus self guided lifestyle education.  The goals are to see if Health Coaching improves well-being and quality of life and physical activity  in patients with COPD and also if the benefits are maintained overtime (lifestyle change).  This study will also be looking at how often a patient visits the doctor unscheduled for COPD related causes.

The purpose of this study is to demonstrate the safety of intravenous infusion (IV) of allo Human Amniotic Fluid (HAF) in subjects with Chronic Obstructive Pulmonary Disease(COPD).

While pulmonary rehabilitation provides benefits to people with COPD, only 1.5% have access to pulmonary rehabilitation each year. The main barriers are related to travel and transportation. This protocol will evaluate the effect of a home-based rehabilitation system on quality of life and steps. The system allows for monitoring by a health care system. A health coach will review the data and provide coaching to facilitate behavioral change and self-efficacy. Patients will be randomized to 1 of 2 groups.

The overall objective of this study is to assess the effectiveness and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol  (delivered by the RESPIMAT Inhaler) compared with the individual components (tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patients with COPD.

The purpose of this study is to assess and characterize health care utilization along with a survey-based parameter of demographic, functional and physiologic domains.  In addition, we hope to see how additional hospitalizations or ER visits impact the trajectory of quality of life after a COPD related health care event. Patients that are eligible and willing to particpate will complete two questionniares at baseline and at 3, 6 and 12 months.   The first questionnaire is about health care utilization.  The second questionnaire is about breathing and quality of life.   

The purpose of this study is to obtain repeated breath acoustic recordings in patients with COPD breathing at rest. These respiratory acoustics will be examined in relation to determinants of disease and/or disease states (classic respiratory pathophysiology) and quality of life measures in these patient populations to determine if any relationship or patterns exist within a condition based on disease severity.       

The overall purpose of this study is to assess the effect of once daily tiotropium and olodaterol in a fixed dose combination compared to tiotropium alone on worsening symptoms in patients with severe to very severe COPD (chronic obstructive pulmonary disease ).

There are currently no devices approved in the United States for providing continuous, temporary, extracorporeal carbon dioxide removal (ECCO2R). Although such devices have approvals outside of the United States, there have been no pivotal randomized, controlled trials (RCT) that have scientifically validated the safety and efficacy of ECCO2R for any potential indication. A primary potential indication is for acute hypercapnic respiratory failure in patients experiencing an acute exacerbation of COPD.
This study is being conducted under an FDA approved IDE to establish the safety and efficacy of an investigational Class III medical device for FDA pre-market approval (PMA) via a ...

The purpose of this study is to determine if myAirvo 3 use increases the time to first moderate exacerbation/severe exacerbation (hospitalization)/all-cause mortality in patients with moderate to very severe COPD. [ Time Frame: 1 year ]

The purpose of this study is to assess the safety and feasibility of mesenchymal stem cells therapy in patients with advanced chronic obstructive pulmonary disease.

This is a multicenter, randomized, double-blind, parallel group, chronic-dosing (24 weeks), placebo-controlled study to assess the efficacy and safety of Glycopyrrolate (GP and Formoterol Fumarate (FF) combination metered-dose inhaler (MDI) (GFF; PT003), GP MDI (PT001), and FF MDI (PT005) compared with Placebo MDI in subjects with moderate to very severe COPD.

The purpose of this study is to determine if fluticasone furoate/vilanterol improves survival in patients with chronic obstructive pulmonary disease with a history of or increased risk of heart disease.

To demonstrate the additional benefit of roflumilast when added on to fixed-dose combination (FDC) LABA/ICS in the reduction of exacerbations in subjects with severe to very severe COPD.

This is a multicenter, prospective, randomized, controlled study designed to evaluate improvement of lung function after treatment with the Spiration Valve System as compared to medical management in the control group. The control group will be evaluated in the same manner as the treatment group.

The Spiration Valve is a small, umbrella-shaped, one-way valve that is placed inside the airways of one lung. It is used to redirect air from the less healthy to the more healthy parts of the lung. This helps to reduce over-inflation and may improve overall lung function and quality of life for people living ...

This study seeks to study the effectiveness of a short mindfulness based pulmonary rehabilitation program prior to a surgical resection in patients with lung cancer and severe Chronic Obstructive Lung Disease (COPD).

The purpose of this study is to assess the effectiveness and safety of D-PLEX administered concomitantly over a period of 90 days (3 months)with the standard of care (SOC) IV prophylactic antibiotic treatment vs. SOC in prevention of post-cardiac surgery sternal infections.

The purpose of this open-label study is to evaluate the safety of continued therapy with inhaled treprostinil in participants who have completed Study RIN-PH-304 (NCT03496623). This study hypothesizes that long-term safety findings will be similar to those observed in the randomized, placebo-controlled, double-blind, adaptive study 'A Phase 3, Randomized, Placebo-controlled, Double-blind, Adaptive Study to Evaluate the  and Efficacy of Inhaled Treprostinil in Patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD)(RIN-PH-304).

The purpose of this study is to assess the safety and clinical utility of the Gala Airway Treatment System on patients with chronic bronchitis in the United States.

The purpose of this study is to determine the prevalence of COPD in patients admitted to the hospital with an acute myocardial infarction (AMI) and to characterize the phenotypic expression and severity of their underlying lung disease. Also to determine the association between beta-blocker use at discharge and cardiopulmonary outcomes in patients with COPD and AMI.

The presence of chronic obstructive pulmonary disease (COPD) would confer increased in-hospital mortality and length of hospital stay in patients with acute decompensated heart failure Assess the (1) prevalence of COPD in patients who are hospitalized for acute decompensated heart failure and (2) the association between COPD and in-hospital mortality or length of stay in this cohort.

The primary purpose of this study is to demonstrate the safety and effectiveness of ozanimod compared to placebo on the maintenance of clinical remission and endoscopic response.

The purpose of this study is to assess the safety and effectiveness of Bronchial Rheoplasty for the treatment of the symptoms of chronic bronchitis in adult COPD patients with moderate to severe chronic bronchitis.

The purpose of this study is to obtain breath acoustic recordings and measures of lung mechanics in patients with COPD, asthma, and cystic fibrosis breathing at rest and during light submaximal exercise. The plan is to examine these respiratory acoustics and mechanics in relation to determinants of disease and/or disease states (classic respiratory pathophysiology) and quality of life measures in these patient populations to determine if any relationship or patterns exist when comparing across respiratory diseases and within a condition based on disease severity.       

People with COPD have a greater risk for symptoms of depression, anxiety, and fear of breathlessness. Those emotions are independently associated with lower physical activity, poorer quality of life, and higher hospitalization and exacerbations; all independent predictors of survival and costs. There is a lack of treatment options to be routinely used in primary clinics for patients with COPD. Systematic reviews suggest that interventions that promote an accepting mode of response, such as mindfulness, might be more appropriate and effective for managing psychological distress in COPD patients, especially breathing-related anxiety. Hypothesis: A home-based 8-week Mindfulness-Based Stress Reduction (MBSR) for COPD ...

Hypothesis: We hypothesize that patients from the Family Medicine Department at Mayo Clinic Florida who participate in RPM will have significantly reduced emergency room visits, hospitalizations, and hospital contacts.  

Aims, purpose, or objectives: In this study, we will compare the RPM group to a control group that does not receive RPM. The primary objective is to determine if there are significant group differences in emergency room visits, hospitalizations, outpatient primary care visits, outpatient specialty care visits, and hospital contacts (inbound patient portal messages and phone calls). The secondary objective is to determine if there are ...

The purpose of this study is to determine whether short-term treatment with Fisetin reduces the rate of death and long term complications related to COVID-19.

The purpose of  this study is to determine the usefulness of palliative care consultations by a specialty physician and a pulmonologist for patients who have advanced lung disease.

The primary objective of this proposal is to develop a Thoracic Specimen Registry at Mayo Clinic. The purpose of the registry will be to support ongoing research in the etiology, early diagnosis, clinical management, and prognosis of lung cancer and other cancers and diseases of the thorax by developing a complete repository of specimens from patients with thoracic disease including but not limited to suspected lung cancer, mediastinal and pleural tumors and from patients at a very high risk of developing other thoracic cancers or other thoracic diseases. 

The purpose of this study is to evaluate the effietiveness of remdesivir (RDV) in reducing the rate of of all-cause medically attended visits (MAVs; medical visits attended in person by the participant and a health care professional) or death in non-hospitalized participants with early stage coronavirus disease 2019 (COVID-19) and to evaluate the safety of RDV administered in an outpatient setting.