Clinical Research Directory

Urolithin A Supplementation During Pulmonary Rehabilitation in Patients With COPD

SUPRA-COPD is a multicenter triple-blind, parallel arm, placebo-controlled randomized controlled trial investigating the efficacy and safety of Urolithin A supplementation during pulmonary rehabilitation in patients with COPD. The goal of the SUPRA-COPD study is to investigate whether Urolithin A supplementation during pulmonary rehabilitation in patients with COPD improves exercise tolerance, along with several other clinically important outcomes, above and beyond pulmonary rehabilitation participation alone. Study participation will be approximately 14 weeks and involves in-person visits evaluating exercise tolerance before and after PR.

A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

COINCIDE: Cardineurovascular dIsease and Obstructive Airway Disease

Patients with chronic obstructive pulmonary disease (COPD) and severe asthma frequently present with cardiovascular comorbidities that contribute substantially to morbidity and mortality. Early identification and appropriate management of cardiovascular disease are increasingly recognized as important components of comprehensive care for patients with obstructive airway diseases. The COINCIDE study is a prospective longitudinal observational cohort study conducted at the Department of Pulmonology, Medical University of Innsbruck. The study aims to systematically document cardiovascular comorbidities in patients with COPD and severe asthma and to evaluate their association with disease progression, therapeutic management, exacerbation rates, symptom burden, and pulmonary function over time. Clinical, functional, laboratory, and imaging data obtained as part of routine clinical care will be collected prospectively during two study visits separated by approximately 24 months. Up to 350 adult participants will be enrolled and followed over a period of five years.

Study of Patient With Frequent COPD Exacerbations

This Study is a multicenter, non-interventional, observational, ambispective (retrospective-prospective) study to evaluate clinical and demographic characteristics, approaches to therapy in outpatients with COPD and frequent exacerbations in the Russian Federation. Planned number of Study site is 35 outpatient centers with experience of treatment of COPD with frequency exacerbations in about 30 regions in Russia.

Indoor Overheating and Physiological Strain in Older Adults With COPD

During warm weather, homes without air conditioning can stay hot for long periods, and most heat-related health problems in Canada happen indoors rather than outdoors. Health Canada recommends that indoor temperatures not exceed 26 °C in homes occupied by people who are more susceptible to heat. That recommendation is based largely on population-level evidence, and very little is known about how susceptible individuals actually respond, physiologically, when indoor temperatures rise above it. Older adults living with chronic obstructive pulmonary disease (COPD) are among the groups identified as more susceptible to heat. COPD involves persistent airflow limitation, reduced lung and cardiovascular reserve, and altered cellular stress responses. Despite this, no laboratory study has directly measured how adults with COPD respond to a full day spent indoors in warm conditions. This randomized crossover trial will measure how older adults with COPD respond to two different indoor environments, each experienced for eight hours on separate days at least one week apart. One day is spent at the recommended indoor temperature limit and the other at a warmer temperature representative of conditions recorded inside Canadian homes during hot weather. Participants remain seated and rest throughout; no exercise or work is performed. Throughout each day, the research team continuously measures core body temperature, skin temperature, heart rate, and measures blood pressure, lung function, breathlessness, thermal comfort, cognitive performance, and balance at set time points. Blood and urine samples are collected at the start and end of each day. Participants are monitored continuously by trained staff. The results are intended to strengthen the evidence base behind Canadian indoor temperature guidance and to inform recommendations for protecting people living with chronic lung disease during hot weather.

To Evaluate the Effect of EXPD-101/FXS7553 Compared With Placebo in Patients With COPD Over 52 Weeks of Treatment

This is a Phase 2 study of the efficacy, safety, tolerability and pharmacokinetics of two doses of EXPD-101 in participants with COPD. Study participants will be randomized to receive either study drug or placebo administered once daily for 52 weeks.

Canadian Consortium on Airway Mucus Occlusions in Asthma, COPD and Chronic Cough

Chronic lung diseases affect one in five Canadians, causing symptoms such as cough, breathlessness, and wheeze. Despite advancements in medical care, these conditions not only impact individuals and their close circles but also present substantial clinical and economic challenges at a national level. This grant is dedicated to addressing three prevalent lung diseases: asthma, chronic obstructive pulmonary disease (COPD), and chronic cough. An alliance of clinicians, scientists, knowledge users, and patient partners from across Canada have come together to establish the Canadian Consortium for Understanding the Role of Airway Mucus Occlusions in Asthma, COPD, and Chronic Cough - "CANMuc." Mucus plays a pivotal role in the symptoms and severity of lung diseases, but its clinical assessment has been challenging. Fortunately, recent medical advances, particularly chest computed tomography (CT), facilitate visualizing and quantifying mucus in patients with lung diseases. Our goal is to initially assess mucus plugging in a diverse group of Canadians without lung disease and then compare these findings to those with asthma, COPD, and chronic cough. The investigators will recruit 100 healthy volunteers for comprehensive clinical and research evaluations, including sputum analyses, breathing tests, quality of life assessments, cough monitoring, and CT scans. In addition, testing will be conducted twice, two years apart, in 240 adult and 50 pediatric participants. This approach will enable the investigators to understand the burden of mucus and how it changes over time, explore proteins or chemicals in mucus that predict mucus persistence, and identify biomarkers that can help guide physicians to prescribe targeted treatments that might work better than others. The CANMuc team's findings will guide strategies for identifying and treating mucus plugging, inform policymakers, and share knowledge with Canadians living with asthma, COPD, and chronic cough.

BREZTRI REGULATORY POST MARKETING SURVEILLANCE IN KOREA

As part of a post-approval commitment requested by the Ministry of Food and Drug Safety (MFDS), this open-label, single-arm, multicentre, observational Post-Marketing Surveillance (PMS) study aims to characterize the safety profile of Breztri in real-world clinical practice settings, either confirming known safety outcomes or identifying previously unsuspected adverse drug reactions. The study will also evaluate effectiveness of Breztri in real-world clinical practice settings, generating essential clinical evidence from a broader and more diverse Korean patient population representative of daily medical practice.

IMPACT COPD Cohort (China)

Chronic obstructive pulmonary disease (COPD) is a major chronic respiratory condition with high prevalence of multimorbidity. COPD and comorbidities interact dynamically, contributing to symptom fluctuation, acute exacerbations, hospitalization, and long-term disease progression. The IMPACT COPD Cohort (China) is a multicenter prospective observational cohort designed to establish a real-world evidence base for integrative Chinese-Western medicine management of COPD with comorbidities. The cohort integrates conventional clinical assessments (symptoms, questionnaires, spirometry, imaging, and biomarkers) with continuous multisensor digital monitoring (e.g., heart rate, blood pressure, activity, sleep patterns, and other physiological and behavioral measures) and digital Traditional Chinese Medicine (TCM) phenotyping (e.g., tongue, pulse, and facial diagnostics). The study aims to characterize risk profiles of high-risk populations and patients with confirmed comorbidities, develop and validate prediction models for comorbidity risk and acute exacerbation events, and support evidence generation for long-term management strategies with early screening and risk warning capabilities across hospital, community, and home settings.

Remote Monitoring of COPD Patients Experiencing an Acute Exacerbation Through Health Evaluations Using Wearable Mobile Technology

Chronic obstructive pulmonary disease (COPD) causes about 3 million deaths annually and significantly burdens healthcare systems, costing the EU 38.6 billion euros, largely due to frequent hospitalizations triggered by acute exacerbations (AECOPD). AECOPD worsens patient health, accelerates lung decline, and lowers quality of life, highlighting the need for early detection. Moreover, these AECOPD events happen in an out-hospital setting and are therefore, not preventable. A clear clinical and quality-of-life need arises to reduce AECOPD-related events and consequent hospitalizations. Mobile health (mHealth) offers a solution by monitoring patients remotely using unobtrusive wearable devices. Parameters like peripheral oxygen saturation (SpO2) and respiratory rate can detect and predict exacerbations. However, no data at home is available of AECOPD events and robust predictive algorithms are lacking. This study aims to monitor vital parameters at home, tracking physical activity, pulse, respiratory rate, SpO2, sleep, and skin temperature from the moment of ER admission until three months post-discharge. Data will be used to gain insight in the COPD progression following an AECOPD event and to construct a predictive model, enabling timely intervention, reducing hospitalizations, and improving outcomes.

The HELlenic Thoracic Society Initiative for CΟPD and CVD

COPD is one of the most common respiratory diseases in Greece, and maybe more than half a million Greek citizens suffer both from COPD and CVD, however their characteristics and management remain unknown. HELICOPD is a national, multicenter, prospective, non-interventional study designed to contribute to better understanding and depicting the demographic and clinical characteristics of this population, the COPD- and CVD-related adverse events in a two-years period, their quality of life and the healthcare resources use. The study is initiated and coordinated by the Hellenic Thoracic Society.

Nebulizer Versus Handheld Maintenance Therapy for Patients With COPD

Multi-site, randomized controlled trial to determine whether patients who report NO symptomatic benefit with their maintenance hand-held inhaler(s), benefit upon switching to nebulized therapy using comparable classes of medications.

Respiratory Syncytial Virus Infection In Exacerbations of Chronic Obstructive Pulmonary Diasease: The RECODE Study

The goal of this observational study is to determine the prevalence of respiratory syncytial virus (RSV) infection and evaluate its association with clinical outcomes in patients with chronic obstructive pulmonary disease (COPD) who experience exacerbations during the RSV season (October-April). The main question it aims to answer is: * What is the prevalence of RSV infection in patients with COPD during exacerbations in the RSV season? * Does RSV infection lead to worse clinical outcomes, including hospitalization, longer length of stay, acute cardiovascular events, and/or death in patients with COPD exacerbations? Researchers will compare patients with RSV infection to those without RSV infection to see if RSV infection results in worse clinical outcomes, such as increased hospitalization, longer stays, cardiovascular events, or death. Participants will: * Be adults diagnosed with COPD who present to the emergency department or day hospital due to acute exacerbations of their respiratory symptoms. * Receive treatment as per standard clinical care for COPD exacerbations, including long-acting bronchodilators and inhaled corticosteroids, and may complete a course of antibiotics and/or oral corticosteroids if prescribed during hospitalization. * Undergo diagnostic testing for RSV infection as part of the clinical routine to determine the presence or absence of the virus during their exacerbation. * Have clinical outcomes monitored, including hospitalization rate, length of stay, and any acute cardiovascular events, as well as mortality during the exacerbation period. * Provide relevant demographic and clinical data, including medical history, COPD severity, comorbidities, and previous exacerbation events.

Hyperoxia During Outpatient Pulmonary Rehabilitation in Chronic Lung Disease - Does it Matter?

Chronic obstructive pulmonary disease (COPD) is a global burden. Treatment options have improved in recent years, pulmonary rehabilitation plays a key role. Oxygen therapy is recommended in patients with a low saturation at rest, but no clear guidance is given for patients who desaturate during exercise. The effect of ambulatory oxygen during exercise is not yet completely understood, especially in those patients with exercise-induced desaturation. Aim: Evaluate the effect of supplemental oxygen therapy during a 3-months long ambulatory pulmonary rehabilitation program on exercise endurance. Patients will either receive supplemental oxygen therapy or room air during exercise training. Methods: A total of 32 patients with a confirmed diagnosis of COPD undergoing pulmonary rehabilitation will be included (male and female : aged ≥ 18 years; stable condition \&gt; 3 weeks (e.g. no exacerbations); resting oxygen saturation (SpO2) ≥ 88% and exercise induced hypoxemia defined by a fall in SpO2 by ≥ 4% and/ or below 90% during a 6-minute walking test). 3-months comprehensive PR for both intervention and control group including: education and awareness, instruction on inhalation therapies, smoking cessation counselling, respiratory and skeletal muscle training in groups, guided walks / cycle ergometer training. The intervention group will be trained using SSOT and the control group will receive sham air (ambient air). Patients and assessors will be blinded. Between group difference in cycling constant work rate exercise test (CWRET) time from baseline to 3 months SSOT (5l/min) vs ambient air will be the primary outcome of this study. Data will be summarized by means (SD) and medians (quartiles) for normal and non-normal distributions. Effects of treatment will be evaluated by mean differences with 95% confidence intervals, T-tests or Wilcoxon matched pair tests as appropriate. A p-value threshold of \<0.05 or a confidence interval not including zero will be considered as statistically significant. Analyses will be performed according to the intention to treat principle.

A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of KIT2014 in Patients With Moderate to Severe COPD

Study investigating the safety, tolerability, pharmacokinetics and early efficacy with KIT2014 over 7 days of treatment in moderate to severe chronic obstructive pulmonary disease patients.

A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

This Phase IIb dose-ranging study will evaluate the efficacy and safety of 2 different doses of AZD6793 compared with placebo tablets in participants with moderate to very severe chronic obstructive pulmonary disease.

Effect of Exercise Order During Pulmonary Rehabilitation on Muscle Strength in Patients With COPD

Chronic Obstructive Pulmonary Disease (COPD) is a chronic multisystem disease frequently associated with peripheral muscle dysfunction, which is strongly linked to prognosis and survival. Pulmonary rehabilitation is a cornerstone of COPD management and includes both cardiorespiratory endurance training and muscle strengthening exercises. Although these components are routinely combined within rehabilitation programs, the optimal order in which they should be performed during the same training session remains unclear. In healthy individuals, performing endurance and strength exercises in different sequences within a single session may influence muscular adaptations, a phenomenon referred to as the intra session interference effect. This effect has never been studied in patients with COPD undergoing pulmonary rehabilitation. Given the high prevalence and clinical importance of muscle weakness in COPD, optimizing exercise prescription may improve functional outcomes and long term benefits. This multicenter randomized controlled trial aims to compare two pulmonary rehabilitation strategies that differ only in the order of exercise administration. Participants with moderate to severe COPD will be randomly assigned to perform either muscle strengthening before endurance training or endurance training before muscle strengthening during each rehabilitation session. The primary objective is to evaluate the impact of exercise order on lower limb muscle strength, assessed by the Five Times Sit to Stand test at the end of the rehabilitation program. Secondary objectives include assessment of exercise capacity, dyspnea, muscle and inflammatory biomarkers, tolerance, and adherence to the rehabilitation program, as well as follow up evaluations up to 12 months after completion. The results of this study are expected to provide evidence to optimize pulmonary rehabilitation programs for patients with COPD and to inform clinical practice regarding exercise sequencing.

Effects of Blood Flow Restriction Rehabilitation on Functional Mobility and Balance Among Chronic Obstructive Pulmonary Disease Patients.

Background: Chronic obstructive pulmonary disease (COPD) is a common lung disease causing restricted airflow and breathing problems. It is sometimes called emphysema or chronic bronchitis. The damage results in swelling and irritation, also called inflammation, inside the airways that limit airflow into and out of the lungs. BFR Rehabilitation is effective in improving functional mobility and balance among COPD patients. Objective: To find out the effects of Blood Flow Restriction (BFR) Rehabilitation on functional mobility and balance among COPD (Chronic Obstructive Pulmonary Disease) patients. Methods: A Randomized Controlled Trial Study was conducted at Gulab Devi Hospital, Hameed Latif Hospital and Arif Memorial Teaching Hospital Lahore. Fifty patients of age 45-60 years with COPD were randomized into two groups. Allocation of patients in two equal groups by lottery method will be through random assignment. Group A was treated with controlled physical therapy while Group B was treated with BFR rehabilitation. Controlled treatment includes low intensity resistance exercises while BFR Rehabilitation includes use of a tourniquet with low intensity resistance exercises. All this information will be collected through a pulse oximeter. Berg Balance Scale will be used for balance and timed up and go test for functional mobility.

Bioequivalence Study of Budesonide/Formoterol Inhalation Powder in Healthy Participants

The goal of this study is to learn if a new formulation of Budesonide/Formoterol Inhalation Powder (160μg/4.5μg), manufactured by Shanghai New Huanghe Pharmaceutical Co., Ltd., works the same as the already approved reference product, Symbicort® Turbuhaler® (160μg/4.5μg), in the body. It will also learn about the safety of the new formulation. The main questions it aims to answer are: * How quickly and how much of the study drug gets into the blood after inhalation, compared with the reference product? * What medical problems do participants have when taking the study drug? Researchers will compare the new formulation to the reference product (the already approved treatment) to see if they are bioequivalent. Participants will: * Be randomly assigned to receive either the new formulation or the reference product in the first period, then switch to the other in the second period * Take a single dose of 2 inhalations in each period, with a 4-day washout period between doses * Have 22 blood samples collected over 36 hours after each dose to measure drug levels in the blood * Visit the clinic for checkups, including vital signs, physical examinations, and laboratory tests * Be monitored for any side effects throughout the study

Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD

This research is being done to test if a drug called omalizumab can help people with Chronic Obstructive Pulmonary Disease (COPD) and allergies. Each participant will be in the study for about 16 months, including 1-3 months of screening, 12 months of receiving the study drug at a clinic, and a follow-up call one month after your final clinic visit.

Study of Patient With Frequent Exacerbations in Moscow

This Study is multicenter, non-interventional, ambispective registry to evaluate the demographic and clinical characteristics, therapeutic approaches and outcomes in COPD outpatients with frequent exacerbations in Moscow

A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00006)

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Functional Social Support in COPD Self-Management

This observational study aims to examine how different types of functional social support (emotional/informational, tangible, affectionate, and positive social interaction) predict self-management capacity among individuals with chronic obstructive pulmonary disease (COPD). The study includes a quantitative cross-sectional survey and qualitative semi-structured interviews (N=20) to explore barriers and facilitators to adequate social support. Findings will inform the development of targeted self-management interventions for COPD patients.

Cross-Regional Unmanned Aircraft Transport of Donor Lungs

This prospective, single-arm study will evaluate the feasibility, timeliness, operational reliability, and preliminary safety of transporting donor lungs by a long-range unmanned aircraft system from Nanning to Guangzhou, China. Adult lung transplant candidates will be enrolled after a donor lung has been legally allocated and clinically accepted and after written informed consent has been obtained. Each formally activated transport task will use standard donor-lung perfusion and cold preservation, triple sterile packaging, and a dedicated transport container with continuous monitoring of temperature, vibration, pressure, position, and communication status. The primary outcome is the actual door-to-door transport time from the donor operating room exit to the recipient operating room entry. Secondary outcomes include transport success, time saved compared with contemporaneous ground-transport estimates, lung preservation and ischemic times, transport-environment performance, donor-lung condition on arrival, and early recipient and graft outcomes through 90 days after transplantation. Twenty-five participants corresponding to 25 formally activated donor-lung transport tasks are planned.