Clinical Research Directory

cfMSC Stem Cell Therapy Targeting COPD

The primary objectives are to evaluate the safety and efficacy of infusion of fully characterized clonally derived fetal mesenchymal stem cells (cfMSCs) for the control of severe symptoms associated with moderate to severe chronic obstructive pulmonary disease.

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.

Improving Medication Management in COPD

A pilot trial to examine feasibility of a pharmacist-led intervention for patients with COPD (Chronic Obstructive Pulmonary Disease) and multimorbidity to improve medication safety and reduce dyspnea. Patients will receive inhaler teaching and medication optimization counseling. Outcomes include feasibility, acceptability, appropriateness, and exploratory measures such as medication discontinuation and patient-reported symptom burden.

Nutritional Risk and Diaphragmatic Thickness in Mechanically Ventilated COPD Patients

Malnutrition and muscle wasting are frequent complications in patients with chronic obstructive pulmonary disease (COPD) experiencing acute exacerbations. In critically ill patients who require invasive mechanical ventilation, nutritional depletion and ventilator-induced diaphragmatic dysfunction can complicate recovery and prolong intensive care unit (ICU) stays. The purpose of this prospective observational cohort study is to evaluate nutritional status and diaphragmatic structure in elderly patients (aged 60 years and older) with COPD who require invasive mechanical ventilation for at least 48 hours. Participants will undergo bedside assessments, including: * Calculation of clinical risk scores within the first 24 hours of ICU admission: modified Nutrition Risk in the Critically Ill (mNUTRIC), Sequential Organ Failure Assessment (SOFA), and Acute Physiology and Chronic Health Evaluation II (APACHE II). * Anthropometric measurements: mid-upper arm circumference (MUAC) and calf circumference (CC) measured at baseline, day 7, and the day of weaning. * Diaphragmatic ultrasonography: point-of-care ultrasound to measure diaphragm thickness at end-expiration and end-inspiration at baseline, day 7, and during weaning trials. The main goal is to evaluate the relationship between nutritional risk (assessed by the mNUTRIC score) and diaphragmatic thickness, and to determine how these parameters correlate with clinical outcomes such as weaning success, total duration of mechanical ventilation, ICU length of stay, and ICU mortality.

Progressive Muscle Relaxation and Deep Breathing Exercises in Patients With COPD

This randomized controlled trial evaluated the effects of progressive muscle relaxation and deep breathing exercises on fatigue and sleep quality in patients with chronic obstructive pulmonary disease (COPD). A total of 90 patients were assigned to three groups: a progressive muscle relaxation exercise group, a deep breathing exercise group, and a control group. Participants in the intervention groups were taught their assigned exercises individually and were instructed to practice them daily at home for 8 weeks. The control group received no study intervention during this period. Fatigue and sleep quality were assessed before the intervention and at the end of the 8-week study period.

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.

Investigation of the Effect of Structured Energy Conservation Techniques Training on COPD Patients

Chronic obstructive pulmonary disease (COPD) is a heterogeneous lung disease characterized by chronic respiratory symptoms (dyspnea, cough, sputum production, and/or exacerbations) due to persistent, often progressive airflow obstruction resulting from abnormalities in the airways (bronchiolitis, bronchitis) and/or alveoli (emphysema). COPD is a multifaceted disease that is not limited to respiratory symptoms but also negatively affects individuals' functional capacity, physical endurance, and participation in daily living activities. Common symptoms include shortness of breath (dyspnea) and a significant feeling of fatigue; this can lead to decreased exercise capacity, limitations in daily living activities, and ultimately dependence over time. Therefore, in the treatment of COPD, not only drug therapy but also interventions aimed at symptom control and improving functional capacity are becoming increasingly important. Energy conservation techniques, included in pulmonary rehabilitation programs, are based on the view that dyspnea occurs most intensely during daily living activities, and that performing these activities in an energy-conserving manner will result in less dyspnea. Energy conservation techniques are one of the trainings given to improve symptom management in COPD patients. Disease symptoms can increase in COPD patients during tasks such as washing hair, drying hair, shaving, reaching, bending, lifting, carrying, pushing, and pulling weights. When appropriate body mechanics and tools that facilitate tasks are used, the amount of energy required during these tasks decreases. In this way, it is thought that patients will be more active in their daily living activities. Breathing exercises are also a component of pulmonary rehabilitation and support the increase of respiratory muscle function and exercise tolerance. Accordingly, it is thought that structured energy conservation techniques training can improve daily living activities, fatigue, and exercise capacity in COPD patients. This research will be conducted as a pre-test-post-test, single-blind, randomized controlled trial to examine the effect of structured energy conservation techniques training on daily living activities, fatigue, and exercise capacity in COPD patients.

A Clinical Study of TQC3721 Inhalation Powder in Patients With Chronic Obstructive Pulmonary Disease

This is a randomized, double-blind, placebo-controlled, dose escalation, multicenter study design. The purpose is to evaluate the safety, tolerability, pharmacokinetics, and pharmacokinetic characteristics of TQC3721 inhalation powder in Chronic Obstructive Pulmonary Disease(COPD) patients with single/multiple dose escalation.

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.

Lung Ultrasound With Acute Exacerbation and Stable COPD

This cross-sectional study aims to compare lung ultrasound findings, functional capacity, and dyspnea among patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD), patients with stable COPD, and healthy controls. The study will include approximately 60 participants divided into three groups (acute exacerbation COPD, stable COPD, and healthy controls). Participants will undergo comprehensive assessments including lung ultrasound, pulmonary function tests, the Modified Borg Scale, the Modified Medical Research Council (mMRC) Dyspnea Scale, the 6-Minute Walk Test, the 1-Minute Sit-to-Stand Test, the COPD Assessment Test (CAT), the Charlson Comorbidity Index, and the BODE Index. The primary objective is to determine differences in lung ultrasound abnormalities, particularly B-lines, consolidations, and lung ultrasound scores, and to investigate their relationship with functional capacity and dyspnea severity. The findings are expected to clarify the clinical utility of lung ultrasound as a non-invasive bedside assessment tool for evaluating disease severity and supporting comprehensive management of patients with COPD.

Factors Associated With Acceptance of Home-Based Pulmonary Telerehabilitation in COPD

Pulmonary rehabilitation improves symptoms, exercise capacity, and quality of life in people with chronic obstructive pulmonary disease (COPD), but access and participation may be limited by travel, organizational, logistical, and personal barriers. Home-based pulmonary telerehabilitation may reduce some of these barriers, although not all eligible individuals accept this mode of care. Identifying the characteristics associated with acceptance or refusal of this model is therefore essential to better define the population most likely to benefit from this approach, tailor the program's delivery and content, and identify potential remaining barriers in order to improve access to care. This retrospective study will use existing data from adults with COPD who were screened at ADIR Association between May 2024 and April 2025 for an 8-week home-based pulmonary telerehabilitation feasibility study. Of 50 potentially eligible individuals, 21 accepted participation and 29 declined. Demographic, clinical, functional, psychological, and geographic characteristics will be compared between individuals who accepted and those who declined participation. Documented reasons for refusal will be described, and factors associated with refusal will be explored using logistic regression.

Time Course of Respiratory Oscillometry Parameters During Nasal High-Flow Therapy in Stable Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease (COPD) can affect the small airways and alter respiratory mechanics. Nasal high-flow therapy delivers warmed and humidified gas through nasal cannulas and may change airway resistance. Respiratory oscillometry is a noninvasive test that measures respiratory resistance and reactance during quiet breathing. This prospective, single-center study will enroll 20 adults with severe or very severe stable COPD who have never used nasal high-flow therapy. During a single study visit lasting approximately 6 hours, participants will receive individualized nasal high-flow therapy for 4 hours. Respiratory oscillometry will be measured before exposure, immediately after device titration, and after 30, 60, 120, 180, and 240 minutes. The primary objective is to describe the time course of the difference between respiratory resistance measured at 5 hertz and at 20 hertz (R5-R20), an indirect index of peripheral airway mechanical abnormalities. Secondary objectives are to describe changes in total and proximal respiratory resistance, respiratory reactance, resonant frequency, and area of reactance. The hypothesis is that nasal high-flow exposure will produce measurable, time-dependent changes in respiratory oscillometry parameters.

Ketogenic Dietary Intervention in Men With Mild-to-Moderate COPD

Chronic obstructive pulmonary disease (COPD) is associated with persistent airflow limitation, systemic inflammation, reduced exercise capacity, and unfavorable changes in body composition. Nutritional interventions may represent a complementary strategy to improve clinical outcomes in individuals with COPD. This pilot randomized controlled trial evaluates the feasibility, safety, and preliminary effectiveness of an 8-week ketogenic dietary intervention in men with mild-to-moderate COPD. Participants are randomly assigned to either a supervised ketogenic diet or a control group receiving standard dietary advice. The ketogenic diet restricts carbohydrate intake and promotes nutritional ketosis, which is monitored using blood beta-hydroxybutyrate measurements. The primary outcome is change in the FEV1/FVC ratio. Secondary outcomes include systemic inflammation assessed by C-reactive protein (CRP), phase angle measured by bioelectrical impedance analysis, functional exercise capacity assessed by the 6-minute walk test, estimated aerobic capacity, body composition, and selected biochemical safety markers. The study aims to provide preliminary evidence regarding whether a ketogenic dietary approach may improve inflammatory status, functional capacity, and physiological outcomes in individuals with COPD.

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.

Improving Patient-Centered Care for Underserved Older African American Patients With Cardiovascular Comorbidities

This is formative evaluation trial guided by the Values Clarification Theory25 and the Cultural Values Theory26, with specific aims to: Aim 1. Develop a culturally appropriate version of the PPC Approach for older AAs with CVCs by assembling a community advisory group of 3 primary care clinicians, 3 older AA patients with CVCs, and 3 AA persons who care for AA patients with CVCs to solicit feedback on the PPC Approach. Aim 2. Determine the acceptability (e.g., program appraisal interviews) and feasibility (e.g., avg. length of program sessions, program participation rate, study completion rate) of the PPC Approach among a sample 20 of under-resourced older southern AA patients with CVCs receiving primary care at Cooper Green Mercy Health Services Authority. Aim 3. Examine the ability of participants to complete pre- and post-test (8 weeks post-baseline) measures of perception of care, treatment burden, shared decision-making, and patient-clinician communication exchange.

Primary Palliative Care - a Feasibility Cluster Trial

This feasibility cluster-controlled randomized trial (RCT) evaluates a complex intervention for the delivery of primary palliative care in Family Health Units (FHUs). The intervention consists of training General Practitioners (GPs) in palliative care through a 30 hour e-learning program and implementing a structured consultation model (4 consultations over 12 weeks) for adult patients with advanced chronic illness. One FHU will receive the intervention and one FHU will follow usual care. The primary goal is to assess feasibility metrics (GP adherence, patient recruitment rate, and patient retention rate), which will inform the design of a subsequent full-scale cluster RCT.

129-Xe MRI Study of Single Triple Therapy Inhaler Effects in COPD Patients With Moderate-severe Dyspnea and/or Poor Health Status With High or Low Risk of Exacerbation

The goal of this study is to study how 12-weeks daily (and optional 48-weeks) single inhaler triple therapy (fluticasone furoate (FF)-an inhaled corticosteroid; umeclidinium (UMEC)-a long-acting muscarinic antagonist; vilanterol (VI)-a long-acting β2-adrenergic agonist) works to treat adults with COPD. The investigators will compare the effects of this medication on adults with COPD who are at low risk of a flare-up and adults with COPD who are at high risk of a flare-up. The main questions it aims to answer are: * Does FF/UMEC/VI improve ventilation defect percent as measured on 129-Xenon MRI in adults with moderate-severe COPD * Evaluate the relationships between the ventilation defect percent and lung function test results Participants will: * Take the inhaler FF/UMEC/VI once daily for 12-weeks (optional 48-weeks) * visit Robarts 2 times (with optional 3rd visit) for tests and imaging

Multi-Center Clean Air Randomized Controlled Trial in COPD

This is a multi-center randomized, sham-controlled clinical trial to determine the effectiveness of an air cleaner intervention aimed at improving indoor air quality on reducing COPD exacerbation risk and improving quality of life, functional status, rescue medication use.

Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations

The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab administered subcutaneously (SC) in adult participants with symptomatic COPD with a history of ≥ 2 moderate or ≥ 1 severe exacerbations of COPD in the 12 months prior to enrolment. Participants should be receiving optimised treatment with inhaled maintenance therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) throughout at least the last 3 months prior to enrolment.

A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study is a randomized, double-Blind, placebo-controlled, Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT002 in Healthy Volunteers and Participants with Chronic Obstructive Pulmonary Disease (COPD).

REGEND001 Autologous Basal Layer Stem Cell Transplantation for Chronic Obstructive Pulmonary Disease (COPD): A Translational Application Study

This clinical trial aims to evaluate the safety and efficacy of REGEND001, an autologous bronchial basal cell therapy, for the treatment of Chronic Obstructive Pulmonary Disease (COPD). COPD is a chronic respiratory condition characterized by persistent airflow limitation and impaired lung function, leading to significant morbidity and mortality worldwide. Current treatments primarily focus on symptom management and have limited impact on disease progression or survival. This study proposes a novel approach using autologous bronchial basal cells, which have demonstrated the potential to repair damaged lung tissue and improve lung function in preclinical studies. The therapy involves the collection of bronchial basal cells via bronchial brushing, followed by their expansion and reintroduction into the patient's lungs via bronchoscopic infusion. The primary objective is to assess the improvement in lung diffusion capacity (DLCO), with secondary endpoints including changes in lung ventilation function (FEV1, FVC) and quality of life (CAT score). The study will also monitor safety, including the incidence of adverse events. Eligible participants are COPD patients aged 40-80 with moderate to severe disease. The trial includes a screening phase, cell collection, transplantation, and follow-up assessments at 4 and 24 weeks post-treatment. This study represents a promising advancement in regenerative medicine for COPD, offering a potential therapeutic option that addresses the underlying structural damage in the lungs.

Exploring the Diagnostic Performance of Dynamic Chest Radiology in Chronic Obstructive Pulmonary Disease

The prevalence of chronic obstructive pulmonary disease (COPD) is on the rise, leading to an increasing economic and social burden. Currently, the diagnosis and staging of COPD heavily rely on pulmonary function testing. However, limitations such as patient cooperation and comorbidities can hinder accurate diagnosis. In situations like a respiratory pandemic, pulmonary function testing may not be feasible. Dynamic chest radiography has emerged as a promising area of research due to its quick procedure, high patient cooperation, low risk, minimal radiation exposure, and reduced direct contact. Recent clinical studies have started to explore the relationship between dynamic chest X-ray measurements and lung function parameters. However, there is a noticeable scarcity of research focusing on the use of dynamic chest X-ray in aiding the diagnosis of COPD, particularly in Chinese populations where cohort data is lacking. Consequently, there is a pressing need to investigate the correlation between various dynamic chest radiograph parameters and lung function indicators, as well as their potential diagnostic value in COPD.

Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate Versus Foster® in COPD

Randomized,double-blind,multicenter,multinational,parallel-group,Phase III study to demonstrate the superiority of the triple fixed combination of beclometasone + formoterol + glycopyrrolate (BDP/FF/GB) administered via pressurised metered dose inhaler (pMDI) over the equivalent dose of Foster® (beclometasone dipropionate (BDP) / formoterol fumarate (FF), in patients diagnosed with chronic obstructive pulmonary disease (COPD) after 52 weeks of treatment.