Clinical Research Directory

Inhaled Treprostinil for Dyspnea and Exercise Intolerance in Mild COPD

The goal of this clinical trial is to evaluate the impact of inhaled Treprostinil on breathlessness and low exercise capacity in patients living with mild chronic obstructive pulmonary disease. Participants will be asked to: * Perform lung function and exercise tests * Have ultrasound of their heart * Have CT images of their lungs * Visit the lab on 5 different occasions (plus one visit to the CT imaging clinic) The researchers will compare the effectiveness and feasibility of inhaled Treprostinil to improve breathlessness upon exertion and exercise capacity

Effect of High-intensity Interval Training on the Lung in Patients With COPD Referred for Lung Volume Reduction Surgery: The PREGENERATE Trial

Patients with chronic obstructive lung disease (COPD) suffer from a progressive loss of lung function that leads to poor quality of life, and often invalidity and early death. Regular exercise can improve quality of life in these patients, but there is a lack in understanding the underlying mechanism of exercise-induced improvement in COPD and it is widely thought not to have any effect on the lung as such. In the present study, the investigators aim to investigate the impact of an extensive high-intensity interval training (HIIT)-based exercise scheme on the regenerative capacity of the lung in patients with COPD on waiting list for lung volume reduction surgery. Design: Prospective randomized controlled clinical trial. Intervention: 24 persons with COPD referred for lung volume reduction surgery will randomly be allocated (1:1) to prehabilitation with high intensity interval training (HIIT) or non-exercise control. Outcomes: The primary outcome is differences in change in differential protein composition in distal lung tissue between HIIT and control groups post-intervention using spatial multimodal proteomics. Furthermore, lung tissue mass, protein composition (mass spectrometry and spatial omics e.g. MACSima), pulmonary blood volume, blood protein profile (biomarkers), diffusion capacity at rest and during exercise, oxygen consumption tests, body composition scan, distal airspace radii and physical functional tests will be measured before and after the intervention. Perspective: This study may fundamentally change the view on the regenerative potential of the lungs in COPD.

COPD Exacerbation Follow Up

The goal of this study is to evaluate the impact of implementing an AI-enabled clinical workflow tool (Viz COPD) on respiratory specialist follow up and clinical outcomes after an acute exacerbation.

Mobile Health Self-Management Intervention for Patient With Chronic Obstructive Pulmonary Disease

This clinical trial aims to evaluate the effectiveness of a pharmacist-led interactive mobile health intervention (serious game) in adults aged 50 years and older with chronic obstructive pulmonary disease (COPD). The study will test whether the intervention improves health status compared with usual care. Secondary outcomes include inhaler technique, medication adherence, health knowledge, dyspnea, clinical events, healthcare utilization, and costs. Participants in the intervention group will receive pharmacist guidance and use the serious game at home for 2 weeks.

University of Michigan COPD Identification Through Lung Cancer Screening Cohort Study - MAP2

The purpose of this study is to obtain new knowledge regarding screening for COPD. This study will use a participant's cancer screening CT scans performed as part of routine health care among current and former smokers at risk for COPD to identify participants who have had a spirometry or will have a spirometry test as part of the study to verify COPD status.

Impact of Combined Cardio-pulmonary Assessment on COPD Clinical Management.

The goal of this randomized clinical trial is to learn whether a combined cardio-pulmonary assessment improves cardiac function, exercise capacity, cardiac biomarkers and health-related quality of life in adults with mild-to-moderate chronic obstructive pulmonary disease (COPD) who are at high cardiovascular risk or have established cardiovascular disease. The main questions it aims to answer are: * Does the combined cardio-pulmonary assessment improve mean left ventricular ejection fraction (EF) over 12 months compared with standard respiratory care? * Does the combined cardio-pulmonary assessment improve mean 6-minute walk distance (6MWD) over 12 months compared with standard respiratory care? * Does the combined cardio-pulmonary assessment reduce mean NT-proBNP over 12 months compared with standard respiratory care? * Does the combined cardio-pulmonary assessment improve mean Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score over 12 months compared with standard respiratory care? Researchers will compare a combined cardio-pulmonary assessment to standard respiratory care to see whether the integrated approach leads to greater improvements in EF, 6MWD, NT-proBNP, and KCCQ-12. Participants will: * Be randomly assigned to receive either a combined cardio-pulmonary assessment or standard respiratory care * Complete a baseline visit that includes clinical assessment, respiratory function testing, blood tests (including NT-proBNP), a 6-minute walk test, and the KCCQ-12 questionnaire * Undergo cardiovascular evaluation (electrocardiogram and transthoracic echocardiography) if assigned to the combined assessment group * Attend follow-up evaluation at 12 months, repeating the same assessments according to their assigned group

Repeat Treatment With Metered Cryospray in Patients With Chronic Obstructive Pulmonary Disease With Chronic Bronchitis

This study is being conducted to determine the safety of repeat metered cryospray (MCS) treatment in patients with COPD with chronic bronchitis previously treated with MCS.

Study That Will Evaluate the Brazilian Population With COPD.

Observational, prospective, multicenter cohort study with consecutive inclusion of COPD patients. Eligible patients will be those with severe and very severe COPD according to the GOLD 2024 (Global Initiative for Chronic Obstructive Lung Disease) guidelines being followed at participating hospitals. The severity of COPD is related to the exacerbation rate, which in turn is related to the progression of the disease and the occurrence of complications and death. There is no national data on this subgroup.

Improving Adherence to COPD Treatments in Primary Care

The goal of this clinical trial is to learn whether a special training program for primary care doctors can help improve treatment adherence and overall outcomes for people with chronic obstructive pulmonary disease (COPD). The main questions it aims to answer are: * Does the training program help patients with COPD take their medications more regularly? * Does it reduce the number of COPD flare-ups (exacerbations)? * Does it improve how well doctors follow current treatment guidelines for COPD? In this study: * Primary care doctors will be randomly assigned to either receive the training or continue their usual care without intervention. * The training includes updated information about COPD, a workshop on inhaler use, and a course on motivational interviewing (a method to support behavior change) * The care of their patients with COPD will be reviewed over 12 months to see if the program made a difference in medication use, flare-ups, and other outcomes.

Probiotics in COPD: Effects on Symptoms, Lung Function, and Inflammation

The goal of this randomized, placebo controlled, double-blind clinical trial is to find out whether a probiotic supplement can help adults with chronic obstructive pulmonary disease (COPD) breathe better and better control their symptoms. The study will try to answer does taking a probiotic supplement, compare with a placebo, reduce shortness of breath, does it improve daily COPD symptoms or change stool patterns by using validated questionnaires; does it affect lung function or inflammation. The results of this study may contribute to a better understanding of the disease, the application of new therapeutic options, and provide a foundation for future research.

A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease

This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk.

Probiotics in Pulmonaty Rehabilitation for COPD

This study aims to investigate various aspects of patients with chronic respiratory diseases undergoing pulmonary rehabilitation supplemented with probiotics. The focus will be on clinical physiological responses, functional performance, respiratory status assessments, nutritional status evaluations, body composition analyses, and biochemical blood parameters, with a primary emphasis on the anti-inflammatory response.

A Phase 2 Trial of JKN24011 in COPD

A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of Subcutaneous JKN24011 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Medical Device Clinical Trial Without CE Marking to Evidence Safety and Performance of the INBENTUS VERSATILE Ventilator in Patients Requiring Assisted/Controlled Mechanical Ventilation and Weaning.

Pre-market clinical trial on 81 aldults participants to evidence safety and performance of the non-CE-marked medical device INBENTUS VERSATILE ventilator. The 81 aldult participants are ventilated between 3 and 48 hours with invasive mechanical ventilation (IMV) in assisted/controlled mode and weaning under partial pressure support or volume support, followed by monitoring period until ICU discharge, hospital discharge or 30 days. The study design differentiates between a Validation Cohort (up to 20 participants) for device validation and a Study Cohort (up to 61 participants) for safety and performance confirmation. Serious Adverse Events related to study device and/or its procedure is defined as the primary safety endpoint, whereas technical failure rate is defined as the primary performance endpoint.

Pulmonary and Total Blood Volume in COPD

Background Patients with chronic obstructive lung disease (COPD) suffer from a progressive loss of lung function that leads to poor quality of life, and often invalidity and early death. This is markedly affected by a reduced exercise capacity and dyspnoea, but the underlying mechanisms are unknown. In the present study, we aim to investigate whether this may involve a reduced pulmonary blood volume secondarily to a reduced total blood volume. Methods Design: Prospective matched comparative study Intervention: None Outcomes: The primary outcome is pulmonary blood volume estimated to total blood volume ratio between patients with COPD and healthy controls individually matched for age, sex, and height. Statistical design: All statistical analyses will be performed using R statistical software version 4.1.1 (R Project for Statistical Computing) within RStudio statistical software version 1.4.1717 (RStudio), and a two-tailed p\<0.05 will be considered statistically significant. Inspection of normality and variance homogeneity will be done by creating qq-plots and histogram. Regulatory considerations: This study will be submitted for approval by Regional Ethical Committee. Perspective: This study will help uncover fundamental aspects of the pathophysiology of COPD.

Respiratory Rehabilitation and Sleep Quality in COPD Patients

COPD affects 5 to 8% of the population in France. The disease consists of inflammation of the large and small airways causing permanent obstruction of the airways and symptoms such as dyspnea, cough and sputum that worsens over time. Among all COPD patients, 40% complain of sleep disorders. Polysomnography data showed a prolongation of sleep onset latency and a decrease in deep sleep, correlated with the severity of daytime hypoxemia. Conversely, poor sleep quality leads to an increase in dyspnea, altered quality of life and increased occurrence of COPD exacerbations. Respiratory rehabilitation has demonstrated significant benefits on exercise capacity, dyspnea, COPD exacerbations and quality of life. To the investigators' knowledge, a few studies have investigated the relationship between physical activity and sleep quality using polysomnography in this population. Thus, the aim of the study is to evaluate the benefits of respiratory rehabilitation on sleep architecture in patients with COPD. Investigators' hypothesis is that a respiratory rehabilitation program would improve the quality of sleep measured by polysomnography. Therefore, patient with COPD and no exacerbation in the previous year will be randomly assigned to the interventional group who perform the rehabilitation program or to the control group who will not perform the program. The primary endpoint is the sleep quality estimated by total sleep time as measured by the mean of 2 independent polysomnography readings, at baseline and after the RR program in the interventional group and after 2 months of usual care in the control group.

How Nocturnal Hypoventilation Predicts Long-term Response to Non-invasive Ventilation in Hypercapnic COPD Patients

The study is an observational, single-center, prospective cohort study aiming to evaluate respiratory mechanics data, as well as clinical and functional parameters commonly used in clinical practice in patients with COPD and hypercapnic respiratory failure. The study population consists of patients with COPD and hypercapnia requiring NIV. The primary objective of the study is to evaluate the association between the reduction in partial pressure of carbon dioxide in arterial blood (PaCO₂) levels at 6 and 12 months after initiating non-invasive ventilation (NIV) and the presence of nocturnal hypoventilation detected at baseline in patients with COPD and chronic hypercapnia. Secondary objectives of this study are the evaluation of the following parameters measured at baseline and/or after 6 and 12 months of NIV treatment in patients with COPD and chronic hypercapnia: * Magnitude of esophageal pressure swing during nocturnal monitoring. * Diaphragm thickness and diaphragmatic thickening fraction assessed by thoracic ultrasound. * Presence of overlap syndrome (COPD + OSA). * Radiological classification of COPD subtypes to assess the association between radiological findings, functional profile, severity of nocturnal hypoventilation, and patterns of chronic hypercapnia. * Respiratory functional parameters, including FEV₁, FVC, FEV₁/FVC ratio, carbon monoxide diffusion capacity (DLCO), and airway resistance (R5 and R20). * Frequency of severe exacerbations and subsequent rehospitalizations during follow-up. * Rate of compliance with respiratory treatment.

Real-World Effectiveness of a Triple Combination BDP/FF/GB Extrafine in a Single Pressurised Metered Dose Inhaler in Brazilian COPD Patients

This multicenter, retrospective-prospective, cohort study aims to evaluate the effectiveness and safety of Extra-fine Beclometasone Diproprionate/Formoterol Fumarate/Glycopyrronium Bromide (EF-BDP/FF/GB) therapy in adults with severe or very severe COPD in Brazil. Around 400 patients will be enrolled across approximately 15 sites. Eligible patients must have started treatment on the day of enrollment or up to three months before enrollment. Data will be collected both retrospectively and prospectively, with baseline information covering up to 12 months before treatment initiation. All assessments will occur during routine medical visits, with follow-up expected at approximately 3 ± 1 month and 6 months ± 2 months. The medication Trimbow® will not be provided as part of the study and must be prescribed and used according to the institution's standard clinical practice, regardless of participation in the study.

Heart Failure With Preserved Ejection Fraction in Patients With Сhronic Obstructive Pulmonary Disease: Clinical Course and Prognosis

Study aim is comparison of heart failire with preserved ejection fraction (HFpEF) detection rate in patients with Сhronic Obstructive Pulmonary Disease (COPD) and the clinical course and prognosis in patients with COPD depending on HFpEF presence.

Coronary Computed Tomography Angiography In Rheumatoid Arthritis Study

The Coronary Computed Tomography Angiography in Rheumatoid Arthritis study is part of the multinational, prospective, observational Autoimmunity and Atherosclerosis in Rheumatic Diseases cohort (https://atacc-rd.com) that includes comprehensive baseline and follow-up assessments at 3, 5, and 10 years. It comprises a main protocol and several optional modules, including a Cardiac Imaging Module, Biobanking Module, Pulmonary Module, and Anxiety and Depression Module. The study aims to advance understanding of cardiopulmonary and psychological comorbidities in rheumatoid arthritis, to improve early identification and management, and to enhance insights into underlying disease mechanisms-ultimately refining risk stratification and targeted prevention strategies. The study includes 4,000 patients with rheumatoid arthritis enrolled through the Cardiac Imaging Module in the main protocol. Participants undergo coronary computed tomography angiography, pulmonary function testing, physical examination, questionnaires, and biobanking, supplemented by genetic, proteomic, metabolomic, and microbiome profiling.

Prevalence and Functional Impact of Urinary Incontinence in Women With Chronic Obstructive Pulmonary Disease Undergoing Rehabilitation: a Cross-sectional Study

Chronic Obstructive Pulmonary Disease (COPD) is a pathology characterized by progressive bronchial obstruction associated with an abnormal inflammatory response, leading to chronic cough, increased bronchial secretions, and irreversible destruction of alveolar walls according to the French-Language Pulmonology Society, in 2023, over 1.3 million patients were treated for this condition in France. The World Health Organization ranks COPD as the third leading cause of mortality worldwide. Historically, COPD predominantly affected men due to higher smoking rates. However, with the rise in smoking among women, recent studies have shown that the prevalence of COPD in women increased from 28 to41 perr 10,000 between 2006 and 2015. Moreover, the clinical presentation of the disease differs between genders. For equivalent smoking exposure, women appear to be more severely affected than men, experiencing greater dyspnea and a higher risk of exacerbations, leading to more frequent hospitalizations and a generally poorer quality of life. Beyond pulmonary impairment, another clinically significant but often underestimated symptom affecting quality of life is urinary incontinence. It appears more common in individuals with COPD, particularly due to chronic cough, repeated abdominal hyperpressure, and pelvic floor muscle imbalance. A few studies have investigated the prevalence of urinary incontinence in people with COPD. One study, involving 995 individuals with COPD, suggested that 34.9% experienced urinary leakage. However, this was a subjective measure based on self-reported data via a simple questionnaire in a case-control study. Another Swedish study estimated the prevalence of urinary incontinence in individuals with COPD at 49.6% in women and 30.3% in men, indicating that women may be at higher risk of developing this symptom. Beyond these studies, the current scientific literature remains relatively limited on this topic, while the impact on patients' quality of life appears to be significant. Among the available studies, one of the most comprehensive was published in 2013 and relied solely on self-administered questionnaires distributed to a broad population (across all disease stages) outside the rehabilitation setting. This overlapping symptomatology-combining COPD and urinary incontinence-profoundly affects patients' quality of life, physically, psychologically, as well as socially. The consequences include limited activities, social withdrawal, diminished self-esteem, and persistent discomfort in daily interactions. This situation can lead to social anxiety or fear of leakage, resulting in absenteeism or abandonment of pulmonary rehabilitation sessions, thereby compromising the effectiveness of treatment. Reduced participation in physical activity perpetuates a vicious cycle: muscle deconditioning, sarcopenia, or even malnutrition, which worsens dyspnea, loss of autonomy, and increases the risks of frailty, infections, and hospitalizations. The study by M. A. Ramon et al. (2018) illustrates this "vicious cycle," where impaired respiratory and physical capacities are self-sustaining. Without specific screening or management strategies for urinary incontinence in this context, breaking this downward spiral and improving overall care trajectories becomes challenging. Raising awareness about the importance of screening for stress urinary incontinence in women with COPD-particularly during pulmonary rehabilitation sessions, where these symptoms are often overlooked due to lack of knowledge and available treatments-is crucial. Such screening would enhance our understanding of the link between chronic cough, stress urinary incontinence, and quality of life. Establishing a correlation between these factors would allow for tailored care pathways and referral of certain patients to targeted pelvic floor rehabilitation. A better understanding of this phenomenon is essential to improve functional assessment and propose adapted therapeutic approaches, which could be the subject of an interventional study in the future. This study thus represents an initial exploratory step aimed at better understanding the prevalence of urinary incontinence in women with COPD undergoing rehabilitation, as well as its impact on quality of life and cough function. It is a preliminary, observational study whose results will lay the foundation for future interventional research.

The Effects of Manual Therapy on the Spatiotemporal Gait Characteristics in Patients With Chronic Obstructive Pulmonary Disease

The primary aim of this study is to investigate the effects of manual therapy on spatiotemporal characteristics of gait and gait variability, functional exercise capacity, and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). The secondary aims of the study are to determine the effects of manual therapy on balance, respiratory muscle strength, quality of life, physical activity, symptom severity, accessory respiratory muscle activation, peripheral muscle strength, chest wall mobility, dysfunctional breathing, pain, and posture.

A Repeat Ascending Dosing Study of the Safety and Clinical Activity of R-3750 in Patients With Mild to Moderate COPD

The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-3750) in patients with mild to moderate chronic obstructive pulmonary disease (COPD)

Photon-counting CT in Chest Imaging

Purpose and objective: This project aims to evaluate photon-counting computed tomography (PCCT) quantitative accuracy using COPDGene subjects. The goal is to establish acquisition protocols for PCCT scans with proper post-processing (e.g., reconstruction parameters and harmonization techniques) that enable reproducible measurements of emphysema metrics (e.g., Perc15, LAA-950, HU accuracy) and airways (Pi10, WA%) in the lungs. Study activities and population group: The study will recruit subjects from a current study at Duke (COPDGene Phase 4, Pro00113442). Here are the aims: * The research team will request consent from participants to acquire PCCT scans at their Phase 4 COPDGene visit. Scans will be performed using a PCCT-specific protocol. * Reconstruct the PCCT images with multiple post-acquisition parameter settings. Apply harmonization techniques that are recently developed by the investigators of this study. Data analysis: * Identify the reconstruction and harmonization conditions that enable reproducible measurements of emphysema metrics (perc15, LAA-950, HU accuracy) and airways (Pi10, WA%), when compared to the counterpart EICT scans. * Demonstrate the non-inferiority and potentially improved capabilities of PCCT scans in cross-sectional and longitudinal studies. Risk/safety issues: The participants are asked to get an additional CT scan with a PCCT scanner at their COPDGene Phase 4 visit. This additional CT scan will be done using an inspiratory chest protocol with a total of 3 mGy (\~1.5 mSv) radiation dose. This is roughly equivalent of 6 month of background radiation. Women who are pregnant will not have a chest CT scan done until they are confirmed to be not pregnant.