Clinical Research Directory

Reducing Exposure With Air Cleaners and Technology

Fine particulate matter (PM2.5) is a type of air pollution made up of extremely tiny particles that can harm our health. Because PM2.5 particles are so small, they can travel deep into the lungs when we breathe. Exposure to PM2.5 can worsen asthma, cause breathing problems, increase the risk of heart attacks, and lead to early death, especially for people with existing heart or lung conditions. In California's Bayview Hunters Point (BVHP), a San Francisco community already facing high levels of air pollution and health impacts, sources of PM2.5 include industrial activity, commuter traffic, heavy-duty diesel trucks, freight trains, and port and maritime activities. The Reducing Exposure with Air Cleaners and Technology (REACT) Study is a partnership between UC Berkeley, UC San Francisco, and Brightline Defense. The goal is to see if air cleaners (also called air purifiers) can help reduce indoor PM2.5 levels and improve respiratory health. For this study, we'll be recruiting 100 households in BVHP to participate. In each home, we'll monitor indoor PM2.5 levels and the health status of household members who are 13 years old or older and have asthma or chronic obstructive pulmonary disease (COPD). Each home will be part of the study for 90 to 120 days, depending on scheduling. Households must reside in BVHP for the duration of the study and not have used an air cleaner in their home within the last 6 months. On Day 1, each household will receive a PurpleAir indoor air quality monitor to measure PM2.5 levels in their home. * For the first 30 days, we'll measure the home's normal air quality (baseline). * After 30 days, each household will receive an air cleaner (Figure 2) with information about how to best use it. * At that point, we'll also turn on a PM2.5 indicator light on half of the PurpleAir monitors. For the other half, we'll keep that indicator light turned off. This helps us study whether seeing the air quality in real time changes how people use the air cleaner. * For the next 30 days, we'll continue monitoring indoor PM2.5 levels. We'll also track how often the air cleaner is used with smart plug data loggers. * After 60 days, if a household isn't using the air cleaner much or it doesn't seem to be working well, we'll offer more training and support. * We'll continue monitoring over the final 30 days of the study.

Rehabilitation in Safety-net Environments (RISE) to Improve Outcomes in Vulnerable Patients With COPD

Chronic obstructive pulmonary disease (COPD), one of the leading causes of death in the US, disproportionately affects low socioeconomic communities. While few interventions effectively modify the course of COPD and improve outcomes, pulmonary rehabilitation is the one notable exception. However, implementation of this resource-intensive program in real-life settings, and in particular, for underserved communities, has proven to be challenging. Safety-net centers that serve primarily under-insured populations lack financial resources to provide pulmonary rehabilitation. The 10-week COPD Wellness and Plus+ Program directly addresses this gap, and yet, programs like these do not automatically lead to improved outcomes, which leads to the implementation of a Health Advocates program to address participant's social needs and barriers to healthcare.

Comparing Advanced Technologies to Standard Testing for the Diagnosis of Airway Disease in Hospital and Community Settings

Airway disease, such as chronic obstructive pulmonary disease (COPD), is usually diagnosed through breathing tests like spirometry. However, it requires people to blow forcefully into a machine several times which can be uncomfortable and difficult for some patients. This study is looking at whether newer technologies and other breathing tests can help diagnose COPD as accurately as standard testing. We will compare these tests in both hospital and community settings. We are interested in understanding how practical and cost-effective these tests are, including how easy they are to use and how comfortable they are for patients to perform.

A Study of WIN378 in Participants With Moderate to Severe COPD (Sirius)

This study is trying to identify the right dose of a long-acting medicine called WIN378 for people with moderate - severe chronic obstructive pulmonary disease (COPD). WIN378 blocks the action of a protein called TSLP that causes inflammation in the lung and may contribute to COPD control and symptoms. The study will test how doses of WIN378 are handled by the body (pharmacokinetics) and assess the safety of the medicine and markers of COPD inflammation in exhaled breath and blood, lung function and COPD control (pharmacodynamics)

A Prospective, Multicenter, Portable Pulmonary Function Comparison Study Aimed at Evaluating the External Clinical Validation of the Chronic Obstructive Pulmonary Disease Auxiliary Diagnostic Software LH-002 (Version: 2.0.0) in Clinical Diagnosis Accuracy

Chronic Obstructive Pulmonary Disease (COPD) is widely underdiagnosed in low- and middle-income countries and regions, due to the lack of accessible tools. Conventional spiromery tests for COPD diagnosis are expensive, require trained personnel to operate properly. Portable spirometry highly relies on the quality assurance of the tests. Since artificial intelligence (AI)-based cough analysis has demonstrated promising results in COPD diagnosis, this study aimed to evaluate the accuracy of an AI-based cough analysis software (Cough Search) compared to a portable spirometer for the auxiliary diagnosis of COPD.

The Efficacy of Non-invasive Brain Stimulation (NIBS) on Cognitive Functions in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The goal of this clinical trial is to examine if non-invasive brain stimulation (NIBS) can enhance cognitive function with chronic obstructive pulmonary disease (COPD) population. The main questions it aims to answer are: * What is the possibility effect of using the NIBS on cognitive functions as well as the cardiopulmonary parameters in COPD population? * What is the relation between cognitive function parameters and cardiopulmonary parameters in COPD population who suffer from cognitive impairment (CI)? Researchers will compare NIBS to a sham-NIBS to see if NIBS works to improve cognitive function in COPD population. Participants will: Receive NIBS or a sham-NIBS 3 sessions/week for 3 weeks for 20 min each session. Visit the clinic at the beginning for baseline assessment then after the completion of the 3 weeks to reassess them. Outcome measures for cognitive parameters and pulmonary parameters will be taken pre and post NIBS intervention

Compare the Effects of Nebulizer Versus Inhaler Based Therapy for COPD Using Long-acting Bronchodilators

The purpose of this study is to compare the effectiveness of inhaled bronchodilators delivered via nebulizers vs. dry powder inhalers (DPIs) in symptomatic participants with Chronic Obstructive Pulmonary Disease (COPD) who have airflow obstruction (FEV1/FVC ≤ 70%) and show significant air trapping (RV ≥ 120% of predicted). The investigators hypothesize that, in patients with symptomatic COPD, therapy with a long-acting anti muscarinic agent/long-acting beta agonist (LAMA/LABA) combination administered by nebulizer will improve hyperinflation (increase in inspiratory capacity and reduction in residual volume) and reduce symptoms related to COPD to a greater extent than LAMA/LABA therapy given by a DPI. The study aims to demonstrate the following: 1. Compare the values of inspiratory capacity (IC) and residual volume (RV) in patients receiving LAMA/LABA by DPI with those receiving LAMA/LABA by nebulizer 2. Compare patient reported outcomes (COPD Assessment Test (CAT score), Baseline/Transition Dyspnea Index (BDI/TDI) and the St. George Respiratory Questionnaire (SGRQ) in symptomatic patients with COPD receiving LAMA/LABA by DPI with those receiving LAMA/LABA by nebulizer

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.

A Study to Understand the Accuracy of a New Breathing Device Compared to Standard Testing for Asthma and COPD

The diagnosis of either asthma or chronic obstructive pulmonary disease (COPD) is currently based on a combination of symptoms, different lung tests and sometimes a 'trial by treatment'. Both COPD and Asthma tests currently include forced breathing using a test known as spirometry which can be difficult and uncomfortable for people to perform and needs expert interpretation. Asthma can require multiple tests in sequence which can make the process of diagnosis long and inconvenient for patients. In the UK, there have been challenges providing enough testing for COPD and asthma, in part because the tests are challenging to provide in the community to everyone who needs one. The STARDUST study aims to test and develop new ways of diagnosing asthma and COPD that are quick, accurate and easy for patient and healthcare professionals to perform. People who have been referred for routine lung testing will breathe normally in and out into a handheld device called the N-Tidal Handset for 75 seconds. This device measures how the level of carbon dioxide (CO2) changes in the breath as people breath through it. The information gathered on the N-Tidal Handsets, called breath records or capnograms, will not be used to alter the diagnosis of any participants in the study. After the capnograms have been collected, the research team will test 'algorithms' that have been developed using artificial intelligence, to see if they can accurately identify the correct diagnosis. Information collected in the study will also be used to make improvements in these algorithms. If confirmed to be accurate, these algorithms could be used in clinical practice to help healthcare professionals make faster, more accessible and accurate diagnoses, especially in settings like GP clinics in the community where access to specialist tests may be limited.

Phase 1 PK Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients

This is a phase 1, single-dose, 2-period crossover study in healthy volunteers to compare the systemic pharmacokinetic (PK) profile of inhaled AERO-002 versus inhaled active comparator product.

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)

The Study of Chronic Obstructive Pulmonary Disease (COPD) Participants Treated With Dupilumab (STRIDE) Registry

The STRIDE Registry will evaluate the real-world effectiveness and safety of dupilumab in participants with COPD. The primary objective is to describe characteristics of participants newly initiated with dupilumab for COPD. Secondary objectives are to determine whether treatment with dupilumab reduces moderate and/or severe COPD exacerbations; to determine the impact of treatment on lung function in COPD participants; to determine whether treatment with dupilumab improves the quality of life in COPD participants; and to describe safety of dupilumab among COPD participants. The external control cohort will include participants with COPD from the National Patient-Centered Clinical Research Network (PCORnet) consortium who are not being treated with dupilumab. In addition, chest images will be collected and banked for future research projects and consented participants will perform home spirometry.

Long-term Effects and Maintenance of Exercise Habits in Individuals With COPD

The study aims to evaluate exercise habits and relevant health outcomes at 6 months and again 12 to 18 months after participation in the COPDEX trial (NCT06551441). Specifically, we will investigate the extent to which participants maintain regular exercise in the absence of supervision, how long-term exercise behaviour is associated with quality of life and physical capacity, and identify key motivational facilitators and barriers associated with sustained exercise participation Primary objective is to investigate health-related quality of life in individuals with COPD at 6 months and again 12 to 18 months after participation in the COPDEX trial. Secondary objectives is to investigate exercise habits, physical activity levels, cardiorespiratory fitness, lung function, functional exercise capacity, and body composition in individuals with COPD 6 months and again 12 to 18 months after participation in the COPDEX trial; to explore differences in long-term outcomes according to original allocation in the COPDEX trial; to identify motivational facilitators and barriers associated with the initiation and maintenance of regular exercise following participation in the COPDEX trial. At completion of the randomised controlled exercise trial COPDEX (protocol no. H-24021751), which examined the effects of 6 months of high-intensity interval training (HIIT; three sessions per week) compared with usual activity, all participants were encouraged to either continue or initiate regular exercise. All previous participants will be invited to participate in the present follow-up study, irrespective of their original allocation (HIIT group or usual activity group).

RESP-FIT: A Respiratory Muscle Strength Training Intervention for COPD

Individuals with chronic obstructive pulmonary disease (COPD) often experience dyspnea, low physical activity, and reduced quality of life. RESP-FIT is a randomized controlled trial evaluating a remotely delivered respiratory muscle strength training intervention combined with mobile health tools to improve dyspnea, respiratory muscle strength, and physical activity in adults with COPD.

Induced Sputum Collection in COPD Patients With and Without a Vibroacoustic Device

Induced sputum is a non-invasive method to collect samples from the airways. It involves inhaling a saline mist to loosen mucus, which is then coughed up. The samples are used to study markers of lung disease. In some people, this procedure yields only small amounts of sample. This study looks at whether adding a vibroacoustic device during sputum induction can increase the amount of sputum collected in patients with chronic obstructive pulmonary disease (COPD). The device applies gentle sound-based vibrations to the chest to help move mucus in the airways. Each participant undergoes two sputum collection procedures on separate days: one with and one without the device. The order is assigned at random. The main comparison is the amount of sputum obtained with versus without the device in the same person. The study also assesses how well the procedure is tolerated.

Evaluation of the Paramedic Evaluation for Acute COPD Exacerbation

Chronic Obstructive Pulmonary Disease (COPD) is a serious lung condition that affects millions of people in the United States. Each year, it leads to about 150,000 deaths, nearly 900,000 emergency room visits, and 700,000 hospital stays. When COPD symptoms suddenly get worse-called an exacerbation-it can seriously harm a person's quality of life and often requires emergency care. Treating these flare-ups early can help prevent hospital visits, but right now, there aren't many good ways to make sure people get care quickly. Mobile Integrated Health (MIH) programs send specially trained paramedics, guided remotely by doctors, to care for patients in their homes. This approach could help people with COPD get faster, more effective care without needing to go to the hospital. In this project, the investigators are testing a new program called PEACE (Paramedic Evaluation for Acute COPD Exacerbation). The PEACE program sends community paramedics to patients' homes-when needed and in partnership with their regular doctors-to manage worsening COPD symptoms early. The study team will adapt the PEACE program to meet the needs of adults living at home with moderate to severe COPD, gather feedback from patients and healthcare providers, and run a small pilot study to see if the program is practical and helpful.

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.

Comparative Efficacy of Once-daily LAMA/LABA Combinations Versus Tiotropium on Constant-work-rate Cycle Endurance in COPD

This study is designed to directly compare the effects of widely available long-acting bronchodilator therapies in patients with chronic obstructive pulmonary disease (COPD). The trial evaluates three fixed-dose combinations of a long-acting beta-2 agonist and a long-acting muscarinic antagonist (LABA/uLAMA)-umeclidinium/vilanterol (Anoro® Ellipta), indacaterol/glycopyrronium (Ultibro® Breezhaler), and tiotropium/olodaterol (Spiolto® Respimat)-against tiotropium (Spiriva®), a long-acting muscarinic antagonist (LAMA) used as monotherapy. The primary aim is to assess their impact on exercise capacity, with additional evaluation of pharmacoeconomic outcomes. The study follows a prospective, randomized, open-label, four-period crossover design. Approximately 100 patients with stable COPD will be enrolled from the 2nd Department of Pulmonology and Tuberculosis, Medical University of Białystok, and the University Hospital Pulmonology Outpatient Clinic. Each treatment will last 28 days, separated by a 7-day wash-out period, so that every participant will receive each therapy. Assessments will include standard clinical examinations, lung function testing (spirometry, body plethysmography, DLCO, multiple-breath washout), cardiopulmonary exercise testing (CPET) on a cycle ergometer, the 6-minute walk test, validated questionnaires (SGRQ, CAT, mMRC, BODE index), laboratory tests, and imaging. These procedures are part of routine COPD evaluation and will allow detailed monitoring of respiratory function, exercise tolerance, and quality of life. The study aims to determine whether dual bronchodilation with LABA/uLAMA combinations provides superior improvements in exercise performance and overall efficiency compared to tiotropium alone. Results may help guide clinical decision-making and optimize cost-effectiveness in COPD management.

HFNC Versus NIV in Hypercapneic COPD Patients

Aim: To compare gas exchange trends, clinical outcomes, and tolerability between HFNC and NIV in COPD patients with mild-to-moderate hypercapnic respiratory failure.

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.

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.

Risk-Based Lung Cancer Detection in COPD Patients

The goal of the interventional study is to evaluate whether risk-based stratification using the PLCOm2012 model and a machine learning (ML) model can identify patients with chronic obstructive pulmonary disease (COPD) who are at high risk of developing lung cancer and may benefit from low-dose computed tomography (LDCT) screening. The study population includes adults aged 50 years and older with COPD and a history of smoking attending an outpatient clinic. The main question it aims to answer are: \- What is the incidence of histopathologically confirmed lung cancer following risk-based stratification? Participants will: * Undergo lung cancer risk assessment using the PLCOm2012 model and an ML-based model based on clinical and laboratory data * Be referred for LDCT if classified as high-risk * Continue standard care if classified as low-risk * Be followed through electronic health records for up to six years to assess outcomes including lung cancer incidence, adherence to LDCT, time to imaging, healthcare utilization, costs, and safety

A Clinical Study of REGEND001 for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)

Chronic obstructive pulmonary disease (COPD) is a common, progressive, and heterogeneous respiratory disorder. It is associated with substantial morbidity and mortality worldwide, leading to progressive decline in lung function, impaired quality of life, and a significant healthcare burden. REGEND001, made from airway basal stem cells with ability to regenerate lung tissue, is promising to COPD treatment. In this study, a multicenter, randomized, blinded, placebo-parallel-controlled trial is performed to verify the efficacy and safety of REGEND001 in treatment of COPD patients with emphysema.

Changing Outcomes Through Achievement Emails in COPD Using Routine Healthcare Audits

This study is exploring how to improve prescribing for people with chronic obstructive pulmonary disease (COPD) in primary care. COPD is a long-term lung condition. Guidelines recommend the most effective inhalers for different patient groups, but in practice, some patients still receive treatments that are less effective or no longer recommended. One proven way to support better prescribing is "audit and feedback." This involves giving GP practices reports showing how their prescribing compares with guidance and with other practices. Audit and feedback can change behaviour, particularly when focused on medicines and when practices have scope to improve. In West Yorkshire, the NHS Integrated Care Board (ICB) is running a quality improvement project (QIP) to reduce inappropriate prescribing in COPD. Every GP practice already receives regular feedback reports. This study will run within that project. The research will test whether the type of email sent with these reports influences prescribing. Practices will be randomly assigned to one of two groups: * Personalised emails: highlighting their own performance, recognising progress, and giving practical suggestions. * Generic emails: a simple notification that the report is available, with no tailored advice. All practices will receive the same reports, seven times over one year; only the email wording will differ. The main outcome will be the change in how many COPD patients are prescribed inhalers that combine a long-acting beta agonist and inhaled corticosteroid (LABA/ICS), which are no longer recommended in COPD. Secondary outcomes will include other COPD prescribing measures identified by a clinical expert panel. The study will also explore factors that might influence effectiveness, such as practice size, deprivation, and COPD caseload. Data will come from existing NHS sources. The ICB already collects anonymised prescribing data for improvement work. For this study, the data will be pseudonymised so researchers cannot identify practices. The University of Leeds will analyse the results, but the research team will not know which code relates to which practice. This study will not change patient care directly. All patients will continue with their usual GP treatment. The aim is to understand whether small changes in delivering audit and feedback make it more effective in supporting best prescribing. In the long term, this could improve the safety and quality of COPD care.