Clinical Research Directory

Long-term Safety and Tolerability of Tozorakimab in Patients With COPD and History of Exacerbations

ROMEO is a Phase III, multicentre, open-label, chronic-dosing extension study evaluating the long-term safety of two dose regimens of tozorakimab in participants with COPD and a history of exacerbations. Eligible participants must have completed one of the predecessor studies.

Collection of Blood From Healthy Patients, Patients With Benign Disease and Patients With Cancer

To acquire blood samples from subjects for various purposes, including: i) determining the sensitivity and specificity of select DNA methylation markers for the detection of various types of cancer, ii) identifying benign conditions that may induce false positive or false negative results, and iii) defining the effects of potential interfering substances, such as chemotherapy drugs.

Transitional Care Model Evaluation 2020

The study is a randomized controlled trial to estimate the effects of the transitional care model (TCM) on hospital admissions and patients' experience during the year following the patient's qualifying discharge. The University of Pennsylvania, where TCM was developed, will be the coordinating center for the implementation. The study will be conducted in three large health systems spread throughout the U.S., drawing patients from seven hospitals in those systems. Eligible patients are older adults (age 65 and older) admitted to a participating hospital with symptoms of heart failure (HF), chronic obstructive pulmonary disease (COPD), or pneumonia (PNA). The evaluation will be conducted by Mathematica.

High Resolution Micro OCT Imaging

The purpose of this study is to learn about using the imaging to make images of the lungs and nose with the long-term goal of the research leading to potential treatments and new therapies for patients with cystic fibrosis.

Technology Assisted Nudging to Increase Physical Activity Among Hospitalised Medical Patients

Primary Objective To investigate if patients hospitalised for older adults with a decreased level of physical function, either related to a chronic condition e.g., COPD, Congestive heart failure, renal failure; infections; frailty and tendency of falling; orthopaedic surgery - after hip fracture will increase their time spent out of bed during hospitalisation and 3 months after discharge through visual feedback and motivational intervention about physical activities from a new mobile technology. Hypothesis Patients hospitalised for medical disease will increase their physical activity level during hospitalisation and 3 months after discharge through visual feedback and motivational intervention from a new mobile technology.

The Reducing REVISITS Study: A Cluster RCT

This type II hybrid effectiveness-implementation trial will concurrently study the comparative effectiveness of virtual vs. in-person COPD care transition programs implemented via virtual mentored implementation approaches with and without co-design methods. The investigators will enroll up to 24 randomized sites (with a goal minimum of 16 sites) to: * Deliver the COPD programs implemented via mentored support in collaboration with SHM Center for Quality Improvement. * Compare the effectiveness and penetration of virtual versus in-person COPD care transition programs implemented along with mentoring support with or without co-design. The investigators aim to determine which combined approach(es) is/are the most effective at implementing evidence-based COPD program interventions and decreasing COPD acute care revisits with the greatest overall impact and sustainability.

Feasibility of Noninvasive Trigeminal Nerve Stimulation During Exercise

The purpose of this study is to examine 1) effects of cutaneous electrical trigeminal nerve stimulation (eTNS) on respiratory control in healthy volunteers and 2) explore the potential of this approach to mitigate dyspnea in patients with chronic obstructive lung disease (COPD).

The Acute Cardiorespiratory Response to Blood-flow Restricted Versus Traditional Exercise Training Regimens (CaRe BFR)

The investigators hypothesize that BFR exercise regimens result in a different acute cardiorespiratory response pattern compared to traditional exercise regimens. Furthermore, the investigators hypothesize that these patterns differ between healthy participants and participants with COPD. Regarding secondary objective, the investigators hypothesize that BFR results in lower blood pressure responses compared to traditional exercise training in both healthy and COPD participants.

Evaluation of Ventilation Defects Downstream of Mucus Plugs in Patients With Muco-Obstructive Lung Disease

In this study, xenon MRI will be used to evaluate regional functional consequences of mucus plugs in the lungs of patients with muco-obstructive pulmonary disease. Mucus plugs will be identified using CT imaging, and xenon MRI will be used to evaluate ventilation and gas exchange impairments in regions of the lungs corresponding to the airways downstream of mucus plugs.

Clinical Trial to Investigate the Safety and Tolerability of EP395 in Patients With COPD

The aim of this clinical trial is to investigate the safety and tolerability of oral, once-daily EP395 administration in COPD patients for 12 weeks.

Health Literacy, Physical and Cognitive Function, Health-related Behaviors, and Quality of Life in COPD

Health literacy is important for controlling disease progression and living a healthy life with illness. High health literacy is associated with higher cognitive performance and lower health-related quality of life. Physical, psychological, and social impairments are seen in chronic obstructive pulmonary disease (COPD). Studies investigating the relationship between health literacy and functional capacity, quality of life, physical activity, cognitive function, health-related behavior, and activities of daily living in individuals with COPD are limited. Therefore, the aim of this study was to compare individuals with COPD with healthy individuals in terms of health literacy, functional capacity, quality of life, physical activity, cognitive function, health-related behavior, and activities of daily living and to investigate the relationship between health literacy and functional capacity, quality of life, physical activity, cognitive function, health-related behavior, and activities of daily living in individuals with COPD.

Michigan Early Disease Progression Cohort

The aim of this project is to develop a disease progression cohort within the University of Michigan Health System to capture pulmonary function, symptom assessments and quantitative imaging among patients at risk for or with an established diagnosis of COPD, focusing however on "early" COPD (age 30-55 and GOLD stage 0,1, 2, and prism).

Effect of Combined Endurance Training on ADL and Walking in COPD Patients

Chronic Obstructive Pulmonary Disease (COPD) is a chronic disease with related exercise intolerance and marked disability due to symptoms such as dyspnea and fatigue. Effort intolerance and exercise-induced symptoms cause marked impairment in completing activities of daily living (ADL). Pulmonary rehabilitation (PR), which has exercise as a major component, is considered a key treatment in the management of COPD since PR is effective in improving exercise tolerance, exercise-induced dyspnea and fatigue, and health-related quality of life. Rehabilitation is also effective in improving the time required to perform ADLs, reducing symptoms and disability. Studies show that rehabilitation protocols with upper limb exercises added to lower limb training are able to give additional benefits in terms of effort tolerance (endurance time at the arm ergometer and oxygen consumption) and reduction of dyspnea at iso-load. The primary aim of this study is to evaluate whether the combined "arm and leg" training modality, compared to a gold standard protocol -involving only the lower limbs training- is more effective in improving ADL performance in terms of reduction of exercise time for a specific test (GLITTRE test).

Responses to Live Attenuated Influenza Virus (LAIV) in Chronic Obstructive Pulmonary Disease (COPD)

This study will determine the functional status of the nasal immune environment with LAIV exposure in COPD persons with frequent exacerbations (defined as individuals with two or more episodes of worsening in COPD symptoms requiring treatment with antibiotics and/or steroids in the prior 12 months) and COPD persons without frequent exacerbations to determine acute exacerbation of COPD (AECOPD)-associated dysfunction in a) cytokines and immune effector cells of the nasal mucosa and b) viral replication. The investigators hypothesize that: 1) COPD frequent exacerbators, compared to COPD infrequent exacerbators, will demonstrate altered mucosal immune responses to LAIV exposure, and 2) COPD frequent exacerbators, compared to COPD infrequent exacerbators, will demonstrate increased markers of influenza viral replication after LAIV exposure.

COPD Flare-Up Clinic After Severe Exacerbations

This prospective randomized controlled trial evaluates whether a specialized "COPD flare-up clinic service" improves outcomes in patients following an acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Patients presenting to the emergency department with AECOPD and discharged or hospitalized will be randomized 1:1 to either structured follow-up in a dedicated flare-up clinic or standard follow-up by scheduled telephone interviews. The researches hypothesize that structured follow-up in a specialized clinic will reduce recurrent exacerbations, optimize long-term COPD management, and improve patients' quality of life compared to standard care.

Trial Evaluating the Rate of Pneumothorax in Severe Emphysema Secondary to Endoscopic Volume Reduction With Two-stage ZEPHYR® Valves Versus Endoscopic Volume Reduction With One-stage ZEPHYR® Valves

Chronic obstructive pulmonary disease (COPD) affects 3.5 million people and is the third leading cause of death worldwide. Emphysema involves air retention in the lungs and is ultimately responsible for a major deterioration in the quality of life. Available drug treatments have moderate efficacy whereas surgical lung volume reduction can improve exercise capacity when offered to a very selected population but at the cost of significant morbidity and mortality. Endoscopic Lung Volume reduction with ZEPHYR® valves improves respiratory function at rest, exercise tolerance and quality of life in patients with little or no interlobar collateral ventilation. If this technique has therefore proven its effectiveness, it is not devoid of complications and is notably responsible for pneumothorax in 27% of cases. The management of this complication is clearly codified, ranging from patient monitoring to the removal of one or more valves. It is therefore a subject of major concern for multiple reasons: high incidence, lengthening of hospital stay, increase in the overall cost of care, potential loss of benefit for the patient in the event of permanent withdrawal. valves and above all a potentially fatal event. A new strategy for implanting ZEPHYR® valves in two stages has been developed in Limoges University Hospital. This innovative algorithm has been evaluated in several non-comparative single or multicenter studies. In those studies, pneumothorax' rate secondary to lung volume reduction with endobronchial valves is rated between 4.5 and 12%. The efficacy of the treatment appears to be comparable with the data found in the trials evaluating in which the entire lobe was treated in one procedure. Moreover, despite two procedures, there does not seem to be any increased risk of occurrence of other complications. Finally, the systematic scheduling of a thoracic computed tomography between the two procedures showed that 26.6% of patients presented a reduction in volume greater than 350mL despite incomplete treatment. These data seem promising but no direct comparison with standard one-step treatment has ever been conducted so far.

Closed Loop Oxygen Control in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Nasal High Flow in the Hospital

The trial aims to evaluate whether the Airvo 3 device in OptiO2 mode can maintain patients' SpO2 levels within the target range better than manual oxygen titration in hospitalized COPD patients with hypoxemia/respiratory distress.

A COPD Data Registry for Participants With Frequent Exacerbations

This registry will collect data on COPD, including the course of disease, treatment patterns, and potential new therapies. The registry will also track the experience of participants and caregivers in clinical practice.

Physiologic Effects of Nasal High Flow on Exercise Tolerance in COPD

This study aims to assess whether to describe the effects of the administration of nasal high flow (NHF) at 70 liters per minute (L/min) in a 6-Minute Walk Test (6-MWT) among Chronic Obstructive Pulmonary Disease (COPD) patients and to characterize the association between self-reported dyspnea with and without NHF at 70 L/min following a 6-MWT.

Emotional-distress-based Integrated Care Programme in Patients With Stable COPD

The investigators have developed a new counselling service that focuses on the emotional distress experienced by people living with chronic obstructive pulmonary disease (\*COPD\*). The new programme is led by an advanced practice nursing (\*APN\*) team. Other professionals are involved in the programme, such as medical staff and physiotherapists. The new counselling service lasts three months. Patients will receive ten counselling sessions with a specialized nurse. The overall objective of the study is to assess the feasibility of the newly developed emotional-distress-based integrated care programme.

Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS

The purpose of this randomized study is to demonstrate direct clinical benefit, i.e., observed benefits in how humans with COPD feel in terms of symptoms (e.g., cough frequency, shortness of breath, and other respiratory symptoms) and function (e.g., lung function, and six-minute walking test \[6MWT\]) after switching to THS compared to continuing to smoking cigarettes.

Muscle Training Induced Angiogenesis in COPD

COPD patients experiment a peripheral muscle dysfunction which impact their exercise tolerance and health-related quality of life. The capillary to fiber interface is reduced and impact the exercise capacity of the patients. While the muscle capillary creation in response to exercise training is blunted in COPD patients, the maturation of the neo-capillaries could also be blunted and contribute to the impaired aniogionenesis in patients. Because the capillary maturation is a sensitive and dynamic process, only different modalities of exercise training and multiple time-points of measures would allow to capture this microvascular adaptation. Aim of the study : Compare the muscle capillary maturation in response to training at 5 and 10 weeks, in sedentary healthy subject trained at the intensity of the ventilatory threshold (60-65% of VO2max), versus :- COPD patients trained at a similar intensity (60-65% of VO2max)- COPD patients trained at a similar absolute intensity (90% of VO2max).

A Clinical Trial to Evaluate the Efficacy and Safety of HRS-9821 Inhalation Suspension in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

The study is being conducted to evaluate the efficacy and safety of HRS-9821 for patients with COPD, and to explore the reasonable dosage of HRS-9821 for patients with COPD.

Effects of Laura Mitchell's and Benson Relaxation Technique On Anxiety, Sleep Quality and Fatigue Among COPD Patients

Chronic Obstructive Pulmonary Disease (COPD) is a progressive lung condition characterized by persistent respiratory symptoms and airflow limitation. Patients with COPD often experience not only physical symptoms like breathlessness and fatigue but also psychological issues such as anxiety and poor sleep quality, which further compromise their quality of life. Non-pharmacological interventions, especially relaxation techniques, have shown promise in improving psychological well-being and physiological outcomes in COPD patients. Among these, Laura Mitchell's relaxation technique and Benson's relaxation response have gained attention for their simplicity and effectiveness. The primary objective of this study is to assess and compare the effects of Laura Mitchell's relaxation technique and Benson's relaxation technique on anxiety, sleep quality, and fatigue levels in patients diagnosed with moderate to severe COPD. By evaluating these parameters, the study aims to determine which method provides greater benefits in managing psychological and physical symptoms associated with COPD. The study will use a randomized experimental design. Participants will be randomly assigned into two groups: Group A will receive Laura Mitchell's relaxation training, and Group B will receive Benson's technique. Both interventions will be practiced daily for 15-20 minutes over a 6-weeks period. Baseline and post-intervention (week 6) data will be collected. Outcome measures will include anxiety (GAD-7), fatigue (FSS) and sleep quality (PSQI). Data will be analyzed using paired and independent t-tests to assess within-group and between-group differences, with significance set at p \< 0.05. The data will be analyzed using SPSS v 25.