Clinical Research Directory

Oral Sildenafil for Exercise Capacity, Dyspnea and Cardiopulmonary Function in COPD

Chronic obstructive pulmonary disease (COPD) is a condition characterized by airway obstruction. Patients with COPD experience significant shortness of breath on exertion. The mechanisms responsible for shortness of breath on exertion are well understood in moderate and severe COPD, but, are poorly understood in mild COPD where symptoms appear disproportionate to the degree of airway obstruction. Mild COPD patients show an exaggerated breathing response to exercise, determined by the breathing response to carbon dioxide production (V̇E/V̇CO2). Recent work suggests that the increased V̇E/V̇CO2 during exercise in mild COPD is secondary to increased deadspace (i.e. lung regions with ventilation but no perfusion) and/or ventilation/perfusion (V̇A/Q) inequality (poor matching of ventilation to perfusion). Researchers have proposed that the increased deadspace or V̇A/Q inequality is secondary to pulmonary vascular dysfunction and hypoperfusion of the pulmonary capillaries. Recently, we have shown that inhaled nitric oxide, a potent dilator of pulmonary vasculature, reduces shortness of breath and V̇E/V̇CO2, and improves exercise capacity in mild COPD. This preliminary finding suggests that pulmonary vascular dysfunction is an important contributor to exercise intolerance in mild COPD. Here, we aim to test whether sildenafil, an oral pulmonary vasodilator, can improve exercise tolerance and shortness of breath in mild COPD.

The Effect of Inhaled Nitric Oxide on Pulmonary Gas-exchange in COPD

Chronic Obstructive Pulmonary Disease (COPD) is a lung disorder commonly caused by smoking, which makes breathing more difficult. When COPD patients exercise, they are not efficient breathers and this leads to serious breathing difficulties, which often causes these patients to stop exercise at low intensities. Even though patients with a mild form of COPD have relatively well preserved lung function, they still have inefficient breathing during exercise. The investigators think that these individuals have problems exchanging fresh gas (i.e., oxygen) into the blood stream because of poor lung blood vessel function. The investigators will test whether inhaled medications, specifically nitric oxide, can improve lung blood vessel function and decrease breathing difficulties during exercise. With this research, the investigators will understand more about breathing efficiency and lung blood vessel function in individuals with mild COPD, and find out whether improving lung blood vessel function helps COPD patients breathe easier and exercise longer. Understanding the reasons behind the feeling of difficult breathing may lead to more effective therapy and improved quality of life in COPD patients.

A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD

This study will assess the safety and efficacy of fixed dose combinations of ensifentrine with two different glycopyrrolate dose levels compared to placebo and to the individual components of the fixed dose combinations, each administered twice a day via standard jet nebulizer, in adult subjects with chronic obstructive pulmonary disease (COPD).

Validation of the C-mo System - Cough Monitoring

The goal of this clinical study is to validate C-mo System's ability to automatically detect and characterise cough, in patients over 2 years old with cough as a key or refractory symptom. The main questions it aims to answer are: 1. Can C-mo System detect cough events? (automatic cough detection) 2. Can C-mo System characterise cough events? (calculation of cough intensity, identification of cough type and presence of wheeze in detected coughs) Participants will be asked to: * Wear the C-mo Wearable device for 24 hours (1 day); * Complete a diary with relevant activities throughout the monitoring period; * Fill-out questionnaires related to coughing frequency and intensity, usability of the device, and impact of cough on quality of life.

A Clinical Study to Evaluate the Efficacy and Safety of TQC2938 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

The study is a Phase II, multicenter, double-blind, randomized, parallel, placebo-controlled clinical trial designed to evaluate the efficacy, safety, tolerability, and pharmacokinetic characteristics of TQC2938 in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). It is anticipated that 256 subjects will be enrolled.

Frespaciguat (MK-5475) INSIGNIA-PH-COPD: A Study of the Efficacy and Safety of Frespaciguat (an Inhaled sGC Stimulator) in Adults With PH-COPD

Researchers are looking for ways to treat pulmonary hypertension (PH) caused by chronic obstructive pulmonary disease (COPD). The goal of the study is to learn if people who take frespaciguat can walk farther in 6 minutes at Week 24 compared to people who take placebo.

Titrated Ambulatory Oxygen in Fibrotic ILD and COPD With Isolated Exertional Hypoxemia

Fibrotic forms of interstitial lung disease (ILD) and chronic obstructive pulmonary disease (COPD) are chronic lung disease which often affect how well oxygen can get from the lungs into the blood. Low blood oxygen levels often leads to shortness of breath which can affect patients' activity levels and quality-of-life. Many people with fibrotic ILD and COPD only have low oxygen levels when they are walking or exercising. Oxygen that is only used for walking or exercise is called ambulatory oxygen therapy (AOT). Laboratory studies suggest that AOT improves shortness of breath and exercise ability. However, real-world studies of AOT have not shown similar results. AOT can be given to patients through different types of equipment, most commonly oxygen tanks or portable oxygen concentrators (POCs). While previous studies have suggested that AOT does not significantly improve patients' breathing or activity in the real-world, these studies most often gave all participants the same amount of oxygen with the same device. However, patients with ILD and COPD often have very different oxygen needs during exercise, and POCs and oxygen tanks are very different in how oxygen is administered. This trial will test the feasibility of a study to determine whether real-world activity, symptoms, and quality-of-life are different with the use of different oxygen equipment when oxygen therapy has been adjusted to meet each participants' oxygen needs. A total of 24 participants (12 with fibrotic ILD and 12 with COPD) who only have low oxygen levels with activity will be randomly assigned to 2-week periods using either no oxygen therapy or oxygen delivered by oxygen tanks or POC. This trial will provide preliminary data to support a larger clinical trial to further test how different AOT equipment titrated to meet individual patients' needs may affect real-world outcomes in people with ILD and COPD.

Video Telehealth Pulmonary Rehabilitation to Reduce Hospital Readmission in Chronic Obstructive Pulmonary Disease

The purpose of this study is to compare the efficacy and safety of a real time video telehealth pulmonary rehabilitation intervention with standard of care in patients hospitalized for an exacerbation of chronic obstructive pulmonary disease (COPD) to determine the impact on hospital readmissions and respiratory morbidity, and to investigate the cost-effectiveness of the intervention.

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in parent studies GB43311 or GB44332.

COPD Care Pathway Among Patients With Cancer

This study gathers information for the development of a COPD care pathway for patients with cancer that reduces the treatment burden of patients, implements critical components of COPD care, and overcomes common barriers to COPD care in the community oncology clinic.

A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.

LPS18583 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 4 study with 2 treatment groups. The purpose of this study is to assess the effect of dupilumab compared with placebo on airway inflammation, resistance, and remodeling including mucus plugging and its association with improvement on lung function, exacerbations, and quality of life improvement in participants aged 40 years of age up to 85 years of age (inclusive). Study details include: The study duration will be up to 40 weeks. The treatment duration will be up to 24 weeks. The number of visits will be 9.

Accelerated Pulmonary Rehabilitation in the Preoperative Period

This proposed project will be a single arm, non-masked study. Participants who are actively smoking with a diagnosis of a new lung nodule, either confirmed or suspicious for lung cancer, with a plan for lung cancer treatment with or without surgical resection will be recruited from the University of Vermont Medical Center (UVMMC)pulmonary, cardiothoracic surgery, and Lung Multidisciplinary Clinic (LMDC). All patients will be enrolled in prehab and offered smoking cessation therapy. The acceptability and feasibility of this intervention will be measured by percent enrollment in study, attendance, barriers to completion, and monitoring of adverse events. The effect of prehab will be measured by traditional metrics, including fitness, respiratory symptoms, and depression scale. Research outcomes will be measured by smoking habits, anxiety, and surgical complications. Investigators estimate that 20 participants over a two-year period will be sufficient to measure the safety and feasibility of this study. Investigators aim to enroll, on average, 2 participants per month in order to complete this study in a timely fashion. Participants will be enrolled in prehab on a rolling basis, as to not delay surgical timeline.

Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype

This is a parallel, Phase 2b/Phase 3, 3-arm study to investigate the efficacy, safety, and tolerability of subcutaneous (SC) treatment with lunsekimig compared with placebo in adult participants (aged 40 to 80 years, inclusive) with inadequately controlled Chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype. Participation to the study consists of 3 periods: * Screening period of up to 4 weeks * Randomized intervention period of approximately 48 weeks * Follow-up period: Approximately 8 weeks The study duration will be up to 60 weeks.

Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD), Characterized by an Eosinophilic Phenotype

This is a parallel, Phase 2b/Phase 3, 3-arm study to investigate the efficacy, safety, and tolerability of subcutaneous (SC) treatment with lunsekimig compared with placebo in adult participants (aged 40 to 80 years, inclusive) with inadequately controlled Chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype. Participation to the study consists of 3 periods: * Screening period of up to 4 weeks * Randomized intervention period of approximately 48 weeks * Follow-up period: Approximately 8 weeks The study duration will be up to 60 weeks.

This is a Non-interventional, Study to Assess Demographic Characteristics and Patient Reported Outcomes in China Patients With SEA Treated With Benralizumab

The objective of this study is to collect empirical data that elucidates the clinical profile and therapeutic efficacy of benralizumab among the patients aged 12 years and above, with severe eosinophilic asthma. The study will focus on the early treatment response, treatment outcomes and the change in asthma control of benralizumab therapy in a real-world setting in China. This study will also describe the physician-reported reasons for discontinuation and switching of benralizumab therapy.

A Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) and Hyperinflation

The purpose of the study is to evaluate the effect of BGF MDI compared with placebo MDI on cardiac and lung function when administered in participants diagnosed with COPD and hyperinflation.

Expression of SLC25A48 in Chronic Obstructive Pulmonary Disease

This study aims to investigate the expression level of SLC25A48, a mitochondrial choline transporter, in peripheral blood mononuclear cells of patients with chronic obstructive pulmonary disease, and to analyze its correlation with inflammatory markers and choline metabolic byproducts.

Study of Clinical and Patient-reported Outcomes in Adults With Moderate to Severe COPD Treated With Breztri/Trixeo

Chronic Obstructive Pulmonary Disease is a leading cause of global morbidity and mortality, especially in low- and middle-income countries. Exacerbations accelerate disease progression and increase the risk of death. Recent recommendations from the GOLD report emphasize the diagnosis of COPD and treatment planning based on a combination of lung function metrics, exacerbation history, and patient-reported symptoms. It is recommending the use of triple combination therapy (ICS+LABA+LAMA) such as BREZTRI/TRIXEO as one of the options in Group E patients. While BGF has demonstrated efficacy in controlled clinical trials, real-world evidence is needed to assess its impact on daily patient outcomes and quality of life. The iCHOROS study is a real-world, international, multicenter, observational study aiming to evaluate changes in clinical and patient-reported outcomes in adults with moderate to severe COPD treated with BGF for 12 months in routine care settings across Latin America, Asia, and the Middle East \& Africa. The study will provide valuable insights into the effectiveness and patient experience of BGF therapy in diverse, real-world populations

Different Inspiratory Muscle Trainings in Patients With COPD

COPD is one of the most life-threatening pulmonary diseases. According to the World Health Organization, it is expected to rise to the third leading cause of death by 2030. Smoking is the most significant contributing factor. COPD reduces lung volumes and causes dyspnea. Over time, respiratory muscle weakness develops, leading to hypercapnia, dyspnea, nocturnal oxygen desaturation, and decreased exercise performance. Pulmonary rehabilitation is the most important component of COPD treatment. Respiratory muscle training should be a mandatory component of the pulmonary rehabilitation program. Combining inspiratory muscle training with functional exercises allows the focus to be on respiratory muscle functions beyond the task of breathing. The purpose of this study was to investigate the effects of Functional Inspiratory Muscle Training on the course of the disease.

Developing an Intervention to Optimize Virtual Care Adoption for COPD Management

VA is a leader in virtual care (VC), including the patient portal, mobile apps, and telehealth programs. VC has great utility for managing chronic conditions like chronic obstructive pulmonary disease (COPD). However, adoption of many VC services has been slow. Lack of awareness about these services is one of the most prominent patient- and healthcare team-facing barriers to adopting VC. This study will develop, refine, and pilot a stakeholder-informed multicomponent implementation strategy to support adoption of VC, referred to as VC-OPTIONS (Virtual Care for Chronic Obstructive Pulmonary Disease Adoption Support). This feasibility trial will pilot the VC-OPTIONS implementation strategy to assess feasibility and acceptability and gather preliminary effectiveness data to inform a larger hybrid effectiveness-implementation trial. The core component of VC-OPTIONS will be the provision of information via VA's Annie texting program to empower patients with knowledge about the array of VC services and how they can be used to support COPD management. It is hypothesized that this strategy will be acceptable and feasible. This work will improve patient and team awareness of and communication about VC services, and support patient access to VC services for COPD management.

A Study to Test the Safety and Effects of Inhaled GDC-6988 in Participants With Muco-obstructive Disease

This study evaluates the safety, tolerability, and activity of inhaled GDC-6988 in participants with muco-obstructive disease.

Predicting Risk Factors for Exacerbation of Chronic Obstructive Pulmonary Disease

Exacerbations of chronic obstructive pulmonary disease (COPD) are unfavourable events in the course of disease for most COPD patients. Published evidence indicates a significant impact of exacerbations, especially if frequent, on patients' health-related quality of life (HRQL), disease progression, mortality, health care utilisation and costs. However, the severity,evolution and outcome of an exacerbation may differ significantly between patients - some patients will recover completely in a short period of time while others may die. The identification of risk factors for an adverse outcome could help in distinguishing patients who require more intense management in order to prevent failures, achieve satisfactory recovery and reduce the negative clinical and socioeconomic impact of exacerbations.The pathogenesis of COPD is still unclear, so there is no specific treatment at present .COPD was considered to be the result of a combination of environmental and genetic factors. Genetic factors play an important role in the acute exacerbation of COPD.Therefore, it is an urgent need to explore the heterogeneity of COPD phenotype from the perspective of genes and to seek individualized prevention and treatment programs.This study is intended to provide a theoretical basis for the prevention, evaluation and development of individualized treatment plans for acute exacerbation of COPD, thereby improving the prognosis of the disease.

The Increase of Lung Capacity Using the Lung Master (Pulmonary Exerciser)

Investigators are studying how a device called The Lung Master device can help people breathe better. The investigational device increases the amount of air our lungs can hold, which is important for overall lung health. The Lung Master is not approved by the FDA. The study has two visits approximately one month apart. In the first visit participants will take a spirometry test, particularly forced vital capacity (FVC), to measure volume change in the lungs. Participants will take the investigational device home to use daily, either in the morning or evening. Use will be recorded in a diary. After one month, participants will return for another spirometry test. Each study visit will take about one to two hours to complete.

Evaluation of the Inhaled TQC3721 Suspension in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease

To evaluate the safety of inhaled TQC3721 Suspension in patients with moderate to severe Chronic Obstructive Pulmonary Disease