Clinical Research Directory

Reducing Breathlessness With Dronabinol in COPD Patients

This clinical trial examines whether Dronabinol, which contains the synthetic psychoactive compound tetrahydrocannabinol (THC), can alleviate severe breathlessness in patients with severe and very severe chronic obstructive pulmonary disease (COPD).

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

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

Dupilumab in Type 2-Inflamed COPD Across the Full Spectrum of Airflow Limitation: An Italian Multicentre Retrospective Cohort Study

This multicentre retrospective cohort study describes lung function and patient-reported outcomes in adults with chronic obstructive pulmonary disease (COPD) and type 2 inflammation who received add-on dupilumab in routine clinical care at six Italian centres. During the study period dupilumab was not reimbursed for COPD in Italy and was provided exclusively through the manufacturer's named-patient compassionate-use programme. Access to that programme required a documented blood eosinophil count of at least 300 cells/microliter, at least two moderate or one severe exacerbation in the preceding 12 months, and persistent symptoms despite maximal inhaled therapy, but set no upper or lower limit on the degree of airflow limitation. As a consequence, the cohort includes participants whose airflow limitation falls outside the post-bronchodilator forced expiratory volume in 1 second (FEV1) window of 30 to 70 percent predicted that was required for entry into the BOREAS and NOTUS registration trials. Post-bronchodilator spirometry, COPD Assessment Test (CAT) score, modified Medical Research Council (mMRC) dyspnoea grade and, where locally available, fractional exhaled nitric oxide (FeNO) were recorded at treatment initiation and at approximately 12 weeks. The variable of primary interest is the change from baseline in post-bronchodilator FEV1 at 12 weeks, the timepoint pre-specified for the lung function endpoint of the registration trials. A pre-specified analysis compares the change in FEV1 between participants whose baseline FEV1 falls inside the 30 to 70 percent predicted window and those whose baseline FEV1 falls outside it. The study is observational and non-interventional. Dupilumab was prescribed independently of the study, according to clinical judgement and the rules of the compassionate-use programme, and no study-specific procedure was performed. Data were abstracted from routine clinical records.

Cognitive Load and Inhaler Technique in COPD

This study evaluates whether cognitive load affects inhaler technique in adults with chronic obstructive pulmonary disease (COPD). During a single study visit, participants will complete assessments of cognitive function, mobility, and respiratory status. Dual-task mobility will be assessed using the Timed Up and Go test performed alone and while completing a cognitive task. Inhaler technique will then be evaluated in two conditions: usual inhaler use without an additional task and inhaler use while maintaining a short sequence of digits in working memory. Inhaler technique will be scored using a standardized five-step device-specific checklist, and inhaler use time will also be recorded. The study will examine whether inhaler technique worsens under cognitive load and whether this deterioration is associated with dual-task mobility performance, cognitive function, respiratory symptoms, and functional capacity. No inhaler training or correction will be provided between the two inhaler conditions. All assessments are performed during a single visit.

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.

Respiratory Therapist-Supported Home Noninvasive Ventilation in Stable Severe COPD Without Hypercapnia

Chronic obstructive pulmonary disease (COPD) can cause persistent breathing problems, reduced exercise capacity, and repeated worsening of symptoms. Noninvasive ventilation (NIV) provides breathing support through a mask. Although NIV is commonly used in patients with respiratory failure, its role in patients with stable severe COPD without hypercapnia is less clear. The purpose of this study was to evaluate the feasibility of a respiratory therapist-supported home NIV program and to explore its potential clinical effects in adults with stable severe COPD without hypercapnia. Participants used a bilevel positive airway pressure device at home for at least 6 hours per day for 3 months. Respiratory therapists provided education and helped set up and adjust the device in collaboration with physicians according to each participant's comfort and breathing pattern. Participants were assessed before starting home NIV and after 1 and 3 months of treatment. Assessments included walking capacity, lung function, arterial blood gas measurements, breathing symptoms, and COPD-related health status. The study also evaluated participants' ability to tolerate and continue home NIV. The findings were intended to determine whether a respiratory therapist-supported home NIV program is practical and potentially beneficial for patients with stable severe COPD without hypercapnia.

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

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

Balance Training Following Pulmonary Rehabilitation on Balance in People With Chronic Obstructive Pulmonary Disease (COPD)

This study aims to see if a co-designed balance training programme called Sport4Steadiness (S4S), is acceptable to people with COPD and if the study procedures, including recruitment and the collection of outcomes, is feasible.

Relationship of Inflammation and Pulmonary Function to Fungal Translocation in HIV

The investigator will study the origin of fungal translocation in HIV, its relationship to the mycobiome, and its relationship to lung function and inflammation. Supported by the preliminary data and published studies, this project is based on the premise that circulating BDG derived from microbial translocation stimulates inflammation and worsens lung function in PWH. Chronic obstructive pulmonary disease (COPD) is a significant public health problem with few therapies that modify disease trajectory. COPD is a leading cause of mortality in the United States associated with increased morbidity and healthcare costs. Long-acting bronchodilators and inhaled corticosteroids are mainstays of therapy that control symptoms and reduce acute exacerbation frequency, but do not have a significant impact on mortality or lung function trajectory. The National Heart, Lung, and Blood Institute's COPD National Action Plan focuses on the critical need for research to characterize COPD risk factors and disease mechanisms in order to improve the understanding of causes and progression of disease. The ultimate goal is to provide precision therapy to appropriate patient subgroups to preserve health or arrest disease progression. Microbial organisms in the gut may have a profound effect on lung disease. The role of the gut-lung axis, defined as the cross-talk between gut microbiota and the lungs, in the pathogenesis of chronic respiratory diseases is emerging as an area of interest. Perturbations of gut microbiota characterized by low microbial diversity and changes in microbiota abundance are linked to childhood asthma risk, airflow obstruction in adult asthma, and severe lung dysfunction in cystic fibrosis. Studies in animals show that both a high fiber diet that modulates gut microbiota and an abundance of beneficial bacterial strains attenuate inflammation, emphysema, and COPD development in response to cigarette smoke exposure in murine models. In humans, recent investigations show differences in the gut microbial communities between COPD patients and healthy individuals as well as shifts in the gut microbiome with acute exacerbations of COPD.

Boosting Regional Integration for COP D Care Through Guided Implementation and Audit of Post Exacerbation Transition Bundle

This is a cluster randomized interventional study. Intervention is implemented at a hospital level and will change overall daily practice. 36 county level hospitals are r an domized to the intervention group or control group at the ratio of 2:1 . Total subjects is 1368 and a size of 38 per hospital .

The Effects of Positive Airway Pressure on the Mucolytic Effects of NAC (TEAM)

The goal of this clinical trial is to determine if positive pressure during inspiration will improve penetration of aerosolized N-Acetylcysteine (NAC) into airway mucus plugs in the lungs of patients with asthma or Chronic Obstructive Pulmonary Disease (COPD). The main questions it aims to answer are: * Does delivery of aerosolized NAC with positive inspiratory pressure have a greater effect on mucus plug burden in the lungs than delivery of NAC without positive pressure. * Does delivery of aerosolized NAC with positive inspiratory pressure have a greater effect on lung function than delivery of NAC without positive pressure. Participants will be assigned (in a single blind design) to the NAC via jet nebulizer group or the NAC via AeroEclipse-VersaPAP nebulizer group. Participants will each complete 5 treatment visits over the course of 30 days. Each treatment visit will consist of two treatments of a 10% NAC (3 mL) and 2.5 mg albuterol (0.5mL) inhalation solution separated by 4 hours, via the nebulization method specific to their group.

Inhaled RB042 in Healthy Adult Volunteers, Healthy Adult Smokers and Patients With Chronic Obstructive Pulmonary Disease

This is a 4-part, randomised, double-blind, placebo-controlled, first in human study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of inhaled RB042.

Copenhagen Comorbidity in HIV Infection Study

Despite efficient antiretroviral treatment for HIV infection, decrease in life expectancy remains. Excess mortality is mainly due to non-AIDS co-morbidity including cardiovascular, pulmonary, and liver related diseases. Both HIV-unrelated and HIV-related risk factors probably contribute to this pattern. At present, most evidence regarding co-morbidity in HIV infection rely on cross-study comparisons of HIV-infected persons with published population rates and few prospective studies in U.S. cohorts. Using well characterized participants from the Copenhagen General Population Study (CGPS) as controls, we aim to include \>1500 HIV-infected persons in the COCOMO study to determine if co-morbidity is more prevalent or develops at a higher rate in HIV-infected persons. The study will asses 1) cardiovascular, 2) pulmonary and 3) liver-related co-morbidity using uniformly collected data in the two cohorts. The investigators aim to study the relative impact of HIV-unrelated and HIV-related factors on development of co-morbidity.

A Study to Evaluate Solrikitug in Participants With COPD (ZION)

A Randomized, Double-blind, Placebo-controlled, Multiple Dose-Ranging Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Solrikitug in Participants with Chronic Obstructive Pulmonary Disease (COPD).

KOrea COpd Subgroup Registry and Subtype Research

The KOrea COpd Subgroup Study team (KOCOSS) cohort is an ongoing, longitudinal, prospective, non-interventional and observational study within the Korean COPD patients. The prevalence of early COPD (mild to moderate COPD based by 2011 GOLD(the Global Initiative for Chronic Obstructive Lung Disease) guideline) is high in Korea. However, the patients with early COPD are not underdiagnosed due to mild symptom. The purpose of this study is to investigate early COPD characteristics and disease course and to form a guideline for early detection of COPD patients and prevention of progression to severe COPD.

LungVITamin D and OmegA-3 Trial (lungVITAL)

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among participants in VITAL and will examine whether vitamin D or fish oil reduces respiratory morbidity, including COPD and asthma exacerbations, the risk of pneumonia, and airflow obstruction/decline of pulmonary function; and whether either of these interventions improves asthma control.

APP-based Medical Device for Education and Training of Inhalation Technique

Primary aim: To investigate if app-based education and training of inhalation technique improves the rate of successful inhalation techniques compared with control group at 6-12 weeks follow-up visit. Secondary aims: To evaluate the feasibility, usability, and safety of the investigational during the study period. Study design: Two-armed, parallel-designed, individual single-blinded stratified randomisation by inhaler (DPI/MDI/both DPI and MDI) controlled trial with assignment (1:1) to (1) standard care and app-based education and training of inhalation technique or (2) standard education of inhalation technique over 6-12 weeks. Subjects: Subjects from the age of 16 years with documented diagnosis of asthma and/or COPD, daily treated with dry powder inhaler (DPI) or metered dose inhaler (MDI), or both, will be invited to voluntarily participate. Exclusion criteria is age \<16 years, no access to use BankID or similar electronic personal identification service, not using smartphone of type Android or iPhone, plan to stop use DPI and/or MDI the following 6-12 weeks from inclusion. No able to independently handle and inhale through DPI or MDI device. Total sample size: Eighty subjects (females and males) with daily treatment for COPD or asthma will be sufficient, based on the assumption of 25% percentage improvement in success rate of correct inhalation technique in the interventional group compared with control group (75% versus 50%) with 80% power at 5% significance level, including dropouts at 6-12 weeks follow-up visit. Intervention: At the baseline visit patients will be randomised to app-based intervention consisting of education and training of inhalation technique of all inhalers used on daily basis (the inhalation app-module). Stratified randomisation based on type of inhaler(s); MDI, DPI or both MDI and DPI will be applied. The intervention is the inhalation app-module, which is a medical device that is embedded the AsthmaTuner app. The AsthmaTuner app is a CE-marked cloud-based system (MDR Class 2b), provided by MediTuner AB, Stockholm, Sweden. The intervention group will be instructed to use the inhalation app-module on daily basis to improve their inhalation technique. Control group: Standard education of inhalation technique using list of standardised criteria and non-app-based education of inhaler technique. Endpoints: Primary endpoint is the rate of subjects with successful inhalation techniques based on subjective critical endpoints (CIP Table 2) and the following objective endpoints at the 6-12 weeks follow up visit: * DPI: PIF \> 30 L/Min, time to PIF \<0.5 seconds measured with the investigational device. * MDI: inspiration time (\> 3 seconds) and PIF less than 60 L/Min measured with the investigational device. Procedures: At baseline, a trained respiratory nurse will subjectively assess and train each patient's inhalation technique according to defined criteria of device handling (standard education). The AsthmaTuner app is downloaded to a smartphone or tablet computer (Ipad) that is wirelessly (Bluetooth) connected to a home spirometer. In this study the Bluetooth spirometer AsthmaTuner from MIR will be used. Education and training of inhalation technique will include measurement of inhalation flow with an adjustable resistance mounted on the spirometer, Airflow Trainer (MIR). The app gives instruction to set the resistance, so it corresponds to the selected inhaler. Questionnaires and interviews will collect information about the feasibility, safety and experienced usability of the investigational device. Analysis: The rate of subjects with successful inhalation technique at 6-12-week visit determined by fulfilling objective and subjective critical endpoints in intention-to-treat approach. The effect of using the inhalation app-module will be analysed with logistic regression analysis across randomisation groups. The secondary analysis of feasibility and the experienced benefit of using the inhalation app-module in clinical practice and for patient's education and training of inhalation technique is estimated on a Likert scale from 1 (not at all) to 5 (strongly agree) and presented as mean and median scores.

GLP-1 Agonists for Lung Function Improvement and Muscle Restoration in COPD

Chronic obstructive pulmonary disease (COPD) is associated with systemic inflammation, obesity-related metabolic dysfunction, skeletal muscle impairment, and progressive decline in lung function. While obesity has historically been viewed as protective in COPD, emerging evidence suggests that excess adiposity and adipokine dysregulation, particularly elevated leptin levels, contribute to chronic inflammation, impaired muscle function, and worse clinical outcomes. Glucagon-like peptide-1 receptor agonists (GLP-1RAs) have demonstrated anti-inflammatory, metabolic, and potential muscle-preserving effects beyond weight loss, making them promising therapeutic candidates for COPD. The GLIMR COPD study is a prospective, randomized, controlled pilot trial designed to evaluate the effects of tirzepatide on lung function, skeletal muscle health, inflammation, and body composition in overweight and obese adults with COPD. Thirty participants will be enrolled at the Cleveland Clinic COPD Center, including 20 participants receiving tirzepatide and 10 age- and sex-matched control participants. Study participants will be followed for 12 months with assessments performed at screening, baseline, 6 months, and 12 months. Tirzepatide-treated participants will undergo standard dose escalation to a maintenance dose of 2.4 mg weekly. The primary objective is to determine the effect of GLP-1 receptor agonist therapy on skeletal muscle function and physiology over 12 months. Secondary objectives include evaluating changes in body composition, systemic inflammation, adipokine signaling, immune function, pulmonary physiology, physical performance, and treatment tolerability. The study is built around three mechanistic aims. First, we will characterize the effects of GLP-1 therapy on systemic inflammation and immune dysregulation using longitudinal blood-based proteomic analyses and adipokine measurements, including leptin and adiponectin. Second, we will investigate the impact of GLP-1 therapy on skeletal muscle mitochondrial function and fatty acid oxidation using muscle biopsies obtained at baseline and 12 months, combined with high-resolution respirometry, transcriptomics, metabolomics, and proteomics. Third, we will assess changes in clinical outcomes including lung function, body composition, muscle strength, and physical performance. Participants will undergo comprehensive phenotyping that includes spirometry, respiratory muscle strength testing, six-minute walk testing, handgrip strength, sit-to-stand testing, body composition assessment, diaphragm ultrasound, and non-contrast CT imaging of the lungs and thighs. Blood samples will be collected for biomarker, proteomic, metabolomic, genomic, and immunologic analyses. Vastus lateralis muscle biopsies will be performed at baseline and study completion to evaluate mitochondrial bioenergetics and molecular pathways associated with muscle remodeling. Eligible participants will be adults aged 40-80 years with COPD, a smoking history of at least 10 pack-years, and overweight or obesity. Individuals with diabetes, active malignancy, recent COPD exacerbations, contraindications to tirzepatide, or conditions that could interfere with study participation will be excluded. This pilot study is designed to generate critical mechanistic and clinical data regarding the role of GLP-1 receptor agonists in COPD. Findings will help define the relationships among obesity, adipokine signaling, systemic inflammation, skeletal muscle dysfunction, and lung disease progression, while providing preliminary efficacy estimates to support the design of a future multicenter randomized clinical trial evaluating GLP-1 therapy as a novel treatment strategy for COPD.

Michigan Early Disease Progression Cohort

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

A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)

The goal of this study is to assess the impact of pharmacist-led benefits investigations and application of clinical practice guidelines on patient access to inhalers and time to hospital readmission or Emergency Department (ED) visit.

PEP Buddy in Pulmonary Rehabilitation

In this study, the investigators will test Veterans with COPD in Pulmonary Rehabilitation. Between two groups, the investigators will give one group a device that assists with breathing and symptoms and the other receives a 'sham' device which does not provide these benefits. The investigators will test to see if the symptoms and exercise capacity of the group who receives this device improves faster in Pulmonary Rehabilitation and has longer lasting benefits after the end of Pulmonary Rehabilitation.

The Effects of Oscillatory Positive Expiratory Pressure (OPEP) Therapy in Patients With COPD

The goal of this non-pharmacologic interventional study is to learn if Oscillatory Positive Expiratory Pressure (OPEP) therapy can improve disease impact and respiratory system dynamics in patients with COPD. The main questions it aims to answer are: Is OPEP therapy able to improve the impact of cough symptoms as measured on a validated symptom score? Is OPEP therapy able to improve the properties of the lung (called reactance) as measured by oscillometry? Researchers will compare the results of the same tests performed before and after 4 weeks of OPEP treatment to see if OPEP treatment improves cough symptoms and lung mechanics. * Participants with COPD will complete in-person baseline tests and will then receive the smart OPEP device. * These participants will then use the smart OPEP device at home, at least twice a day, for 4 consecutive weeks. * Finally, these participants will return to complete in-person end-of-study tests.

Respiratory Muscles in End-stage Lung Disease: Pathophysiological Processes & Clinical Consequences

Rationale: In patients with chronic lung diseases, the role of respiratory muscle dysfunction has been underestimated. Also, current treatment options, like chronic NIV and lung transplantation (LTx), might also have deleterious effects on the respiratory muscles, and the mechanisms are poorly understood. Therefore in this exploratory study the objectives are to: 1. Determine in vivo respiratory muscle function and progression of respiratory muscle dys-function in end-stage COPD patients 2. Establish the correlation between changes in the structure and contractility of respiratory myofibers and in vivo respiratory muscle function. 3. Establish the effect of chronic NIV on structure and contractility of respiratory muscle fi-bers 4. Determine whether the structure and contractility of respiratory muscles cells at the time of LTx predicts clinical recovery post-LTx. Study design: The study will be an exploratory observational cohort study following patients on the LTx waiting list during the waiting period and afterwards until they showed functional recovery of respiratory muscle function. Study population: Adult COPD patients on the LTx waiting list will be included. Intervention (if applicable): None Main study parameters/endpoints: To assess clinical functioning of the respiratory muscles we will assess respiratory electrical activity as a measure of respiratory effort by surface EMG, and thickening fraction of the diaphragm and intercostal muscles and diaphragm excursions by ultrasound and maximal in- and expiratory pressure to assess muscle output; all before and after LTx. We will relate and correct these data for hyperinflation and degree of lung damage by using data from standard care lung function tests and CT scans, and will relate these measurements to prior treatment (NIV settings) and outcome after LTx, by retrieving these data from the EPD. To assess contractility of respiratory myofibers and in vivo respiratory muscle function, biopsies will be taken during LTx surgery and the biopsies will be analyzed in the lab of Prof. Ottenheijm (AmsterdamUMC) for individual myofiber functioning (strength, calcium sensitivity, myofiber characteristics) and in the lab of Dr. Pouwels for extracellular matrix characteristics. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Overall, risks are believed to be minimal. The clinical measurements are non-invasive and/or regular performed in clinical practice. Also, we decided to do those measurements during regular control visits, limiting the burden for the patients. Taking biopsies from the respiratory muscles during surgery has been extensively performed without any risk; the biobank of the Ottenheijm group contains \> 500 samples and never any complication has been observed. Also, in preparation of the present study we performed a pilot study in 12 COPD patients of whom.. biopsies were taken at the UMCG without side effects or complications. The biopsies will be done with the patients being under full anesthesia, so participants will feel no discomfort.

A Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS-9821 Powder for Inhalation Administered as a Single Dose in Healthy Participants and Multiple Doses in Patients With COPD

The aim of this study was to evaluate the safety and tolerability of HRS-9821 Powder for Inhalation administered in a single dose in healthy individuals and multiple doses in patients with COPD。