Clinical Research Directory

Perception of the Benefits and Effectiveness of Inhalation Therapy in Patients With Obstructive Dyspnea

Obstructive ventilatory disorders, including chronic obstructive pulmonary disease (COPD), asthma, and pulmonary emphysema, are chronic conditions characterized by progressive airflow limitation and worsening dyspnea, leading to increasing restrictions in daily activities and quality of life. Although these diseases are not curable, early diagnosis and appropriate treatment can slow disease progression, reduce exacerbations, and preserve functional capacity and well-being. Adherence to prescribed inhaled therapies is therefore essential from the earliest stages of the disease. However, both clinical experience and published evidence suggest that many patients with COPD and asthma experience poor disease control, relapses, and exacerbations due to inadequate inhaler use and suboptimal treatment adherence. Previous research has explored treatment satisfaction among patients with COPD and examined perceptions and beliefs regarding pharmacological therapies in other chronic conditions, such as diabetes, depression, and autoimmune diseases. Studies have also highlighted the importance of adopting a patient-centered approach when selecting inhaler devices based on individual patient characteristics. Nevertheless, little is known about how patients with obstructive ventilatory disorders perceive inhaled therapies and their role in disease management. The aim of this study is to investigate patients' perceptions of inhalation therapy, focusing on factors that influence its use, the value attributed to inhaled medications, preferences regarding the route of administration, awareness of the underlying disease, perceived barriers to treatment, and beliefs about medications in general. Understanding how patients perceive both the treatment and its route of administration is a key component of patient engagement, which emphasizes patients' active involvement in managing their health and healthcare pathway. Currently, no validated tools, either internationally or in Italian, are specifically designed to assess perceptions of the usefulness and effectiveness of inhalation therapy in patients with obstructive ventilatory disorders. This study therefore aims to address an important gap in the literature and support the development of more patient-centered therapeutic strategies.

Comparison of Patients With COPD and PRISM

COPD is a preventable and treatable lung disease characterized by persistent and progressive airflow limitation. PRISm, on the other hand, is a spirometry pattern that does not meet COPD diagnostic criteria despite symptoms and functional impairments, but requires maintenance. PRISm can predispose to the development of COPD and exacerbations, and can reduce exercise capacity by reducing respiratory function and oxygen consumption. There are no studies in the literature comparing respiratory muscle strength, peripheral muscle strength, and oxygenation in PRISm, COPD, and healthy individuals. Therefore, this study aimed to evaluate these parameters and compare them with healthy individuals.

Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients

This is a phase 2b, randomized, double-blind, placebo-controlled, dose-ranging,14-day dosing, 2-period crossover study in participants with chronic obstructive pulmonary disease (COPD).

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).

Genetic Variation in IgG in Alpha 1 Antitrypsin Deficiency

The goal of this study is to learn whether patients who have a genetic mutation in the genes that cause alpha 1 antitrypsin deficiency also have genetic variation in nearby genes that can increase risk for reduced immune function and respiratory infections. To investigate this hypothesis, we will compare immune responses to the 20-valent pneumococcal conjugate vaccine (PCV20, Pfizer) between participants who have one abnormal copy of the SERPINA1 gene and either no COPD exacerbations, vs those with 2 or more COPD exacerbations in the past year.

Home Air Purification for Eosinophilic COPD

This study evaluates the influence of home air purification on the lung health of adults with eosinophilic COPD. Half of the participants will receive real air purifiers (HEPA filters) and half will receive sham air purifiers.

A Prospective Study of Cardiovascular Risk of Patients Admitted for Acute Exacerbation of COPD

This is a prospective study to assess the burden of existing or hidden cardiovascular (CV) and renal disease in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in a Hong Kong public hospital setting. By implementing a chronic obstructive pulmonary disease (COPD) discharge care bundle with integrated CV/renal screening, the study aims to quantify undiscovered disease prevalence, evaluate risk factors for future exacerbations, and compare re-admission rates against historical controls, ultimately informing integrated cardiopulmonary management strategies.

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

Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3

The objective of this study is to assess the safety and efficacy of Apreo BREATHE system when used to support native airways and release trapped air in the treatment of adult COPD patients with emphysema suffering from dyspnea due to hyperinflation despite optimal medical treatment. The Apreo BREATHE Airway Scaffold is a permanent implant designed to tent open native airways. The study will include up to 250 participants at up to 25 study centers located in the United States and Europe. Study subjects will be followed for 3 years. The main questions it aims to answer are: Is it safe? Does it work?

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.

A Multi Center Study Testing a New Implant for Adults With Severe Emphysema

A study taking place at multiple sites in the United States, Europe and Brazil to evaluate how well a new therapy for severe COPD/emphysema works, and how safe it is.

Feasibility of Noninvasive Trigeminal Nerve Stimulation During Exercise

The purpose of this study is to examine 1) effects of cutaneous electrical trigeminal nerve stimulation (eTNS) on respiratory control in healthy volunteers and 2) explore the potential of this approach to mitigate dyspnea in patients with chronic obstructive lung disease (COPD).

Revefenacin in Acute Respiratory Insufficiency in COPD

RARICO is a pragmatic, randomized, controlled, double-blinded, multi-center trial evaluating the safety and feasibility of nebulized revefenacin in comparison to nebulized ipratropium in patients with COPD and acute respiratory failure requiring invasive mechanical ventilation.

Nurse Coach-Led Early Palliative Care for Older Adults With COPD and Their Care Partners: The Project EPIC Pilot RCT

Chronic obstructive pulmonary disease (COPD) is the third leading cause of death in older Americans. COPD increases in frequency with age, and older adults with COPD often have significant unmet geriatrics-palliative care needs that results in reduced quality of life, high healthcare utilization, and care at the end of life that does not align with the values and wishes of patients and their care partners. Older adults with COPD could benefit from proactive geriatrics-palliative care before the end of life. However, no geriatrics-palliative care interventions have been systematically developed and tested in community-dwelling older adults with COPD and their care partners. As the number of older adults with COPD increases to levels unmatched by current palliative care workforce trends, innovative strategies are desperately needed to improve the delivery of geriatrics-palliative care in COPD before the end of life. Project EPIC (Empowering People to Independence in COPD) is a multiphase study to refine and pilot test the EPIC telephonic nurse coaching intervention in older adults with COPD and their care partners. EPIC is informed by the ENABLE (Educate, Nurture, Advise Before Life Ends) early palliative care intervention that improved quality of life and mood for patients with advanced cancer and has been iteratively refined over decades and rigorous randomized controlled trial testing. In the intervention, palliative care-trained nurse coaches deliver the Charting Your Course Curriculum over the phone to patients (six sessions) and their care partners (four sessions), with activities and monthly telephone follow-up following a manualized curriculum. We conducted a formative evaluation in a diverse and multidisciplinary group of stakeholders to refine ENABLE for patients with COPD and pilot tested the potential feasibility of the refined intervention, EPIC, in patients and their care partners. The current study summatively evaluates EPIC through a hybrid effectiveness-implementation pilot randomized controlled trial in dyads of community-dwelling older adults with moderate to very severe COPD and their care partners randomized to usual care (control) versus EPIC (intervention). The primary outcomes are intervention feasibility and acceptability. Secondary outcomes include Life-Space mobility, quality of life, cognitive impairment, functional status, palliative care uptake, and care partner burden.

Assess Accuracy of Primary Care Asthma and COPD Diagnosis Using Oscillometry and FeNO vs Specialist Diagnosis

Current diagnostic methods for asthma and chronic obstructive pulmonary disease mostly depend on pulmonary function tests, especially spirometry. While spirometry is a foundational tool, its diagnostic accuracy is often limited by the patient's ability to perform forceful breathing maneuvers, as well as technical and reproducibility challenges, and the need for proper equipment and training. These constraints can compromise effective diagnosis of asthma and COPD in primary care settings. Prompt and accurate diagnosis by primary care physicians is essential for better patient outcomes. Although variable airflow limitation often measured as a change in FEV1 after bronchodilator is a hallmark of asthma, inconsistencies in test quality and reversibility criteria create challenges in distinguishing asthma from COPD. These complexities highlight the need for alternative diagnostic tools beyond traditional spirometry. This observational study is designed to evaluate the diagnostic accuracy and technical feasibility of using oscillometry and FeNO testing in primary care for suspected asthma and COPD, compared to conventional specialist-based diagnostics. The study will be conducted across 7 countries in the MEA, Asia, and Latin America, with two hospital sites per country. Primary care physicians will be trained in oscillometry and FeNO testing using standardized protocols and tools such as the Ambulatory Lung Diagnosis System following GINA and GOLD guidelines. Eligible patients will provide consent, complete a history and symptom questionnaire, and undergo primary care-based assessment for a provisional diagnosis. If specialist assessment cannot occur the same day, it will be done within three days. No follow-up visits are planned. Study outcomes will inform the feasibility and accuracy of integrating these methods into routine care, aiming to improve the early and reliable diagnosis of asthma and 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 .

COPD Resources, Education, and Activity Designed for You Study

Although COPD self-management treatment programs are effective in reducing COPD-related hospitalizations and increasing quality of life, there is a limited understanding of 'how and why' they work. The proposed research will use an engineering-inspired study design to identify effective COPD self-management treatment components and guide its 'real world' implementation. The long-term goal of this line of research is to build an optimized COPD self-management program, and scale the program up to reduce the burden of COPD at a population health level.

Evaluating Customized Antibiotic Duration (CDA) Strategy in Acute Exacerbations of COPD

The goal of this clinical trial is to learn whether a shorter course of antibiotics (7 days) works as well as the usual longer course (14 days) for adults admitted to hospital with a flare-up of chronic obstructive pulmonary disease (COPD), a long-term lung disease. The trial takes place at CDA Hospital Islamabad, Pakistan. The main questions it aims to answer are: * Do patients who take antibiotics for 7 days recover as well by Day 30 as patients who take them for 14 days? * Does the shorter course lead to fewer side effects and less antibiotic use, without more treatment failures, relapses or hospital readmissions? Researchers will compare a 7-day antibiotic course with the usual 14-day course to see if the shorter course is just as effective. Participants will: * Be assigned by chance (like flipping a coin) to take antibiotics for either 7 days or 14 days. Their doctor chooses which antibiotic to use. * Receive all other usual hospital care for their COPD flare-up. * Have check-ups about 3-5 days, 7 days, 14 days and 30 days after joining the trial, in hospital or by telephone, to record their symptoms, any side effects and any return to hospital. About 560 adults will take part.

RESP-FIT: Technology-Enhanced Self-Management in COPD

30 adults, aged 40 and older with mild to moderate COPD, will be recruited for this study. Participants must be willing to continually wear a FitBit activity monitor, have access to a smartphone or Wi-Fi/Data-enabled iPad, and be willing to complete respiratory muscle strength training exercises as well as reports on their smartphone at least 5 times per week for a 6-week period. Participants will be given a bluetooth inhaler device and a training app (RESP-FIT). This application will collect inhaler data and allows patients to self-report their daily symptoms. The goal of this study is to test whether use of the personalized inhaler device with the app strengthens lung function, promotes physical activity, and improves disease symptom self-management in persons with COPD.

Effectiveness of Pollution Monitoring in Clinical Exercise Rehabilitation

The primary objective of EPIC-AIR is to evaluate the feasibility and potential effectiveness of integrating real-time air pollution monitoring into cardiac rehabilitation (CR) and pulmonary rehabilitation (PR) programmes via an online platform that delivers both exercise prescription and air pollution guidance. Specific objectives are: (1) to determine whether access to real-time air quality data reduces modelled ambient pollution exposure (PM2.5, PM10 and NO2) during outdoor physical activity in CR/PR patients and healthy volunteers; (2) to assess the feasibility of the trial design, including recruitment, randomisation, retention, adherence and completeness of outcome data; (3) to measure the impact of the intervention on physical activity levels, health-related quality of life and cardiovascular biomarkers; and (4) to inform the design and sample size of a future definitive randomised controlled trial

The CANadian EXAcerbation of COPD Trial

The natural history of Chronic Obstructive Pulmonary Disease (COPD) is marked by acute, episodic attacks known as exacerbations of COPD. These events are associated with increased systemic inflammation, lung function decline, hospitalization, and mortality. Despite their high clinical burden, the mechanisms underlying exacerbations, as well as effective approaches to their diagnosis, monitoring, and treatment, represent important unmet clinical care gaps. CAN-EXACT is a prospective longitudinal observational cohort consisting of patient participants with moderate, severe, and very severe COPD with a history of frequent exacerbations. Participants undergo detailed clinical, physiological, imaging, and biological assessments at baseline and at a two-year follow-up visit. Every two weeks, participants complete self-reported symptom and exacerbation questionnaires and continuously wear a biometric wristband to remotely monitor respiratory, cardiac, sleep, physical activity, and autonomic parameters. When participants experience an exacerbation requiring in-person unscheduled acute care, several bedside tests and procedures are performed on each occasion. Biological samples, collected both at the baseline and the follow-up study visits as well as during each acute exacerbation requiring in-person care, are analyzed and are then transferred to a biobank. This overall cohort design allows for both the comprehensive phenotyping of baseline clinical risk factors as well as for the deep phenotyping of each individual acute event.

Acoustic Waveform Respiratory Evaluation

The study will evaluate the feasibility of using smartphone speakers and microphones to evaluate the caliber of the airways, detect airway obstruction, aid in airway disease diagnosis, and identify disease exacerbations.

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).

Personalizing Veterans' Lung Cancer Screening and Diagnosis

Lung cancer screening with low-dose chest computed tomography (CT) is currently recommended for high-risk individuals who are 50 to 80 years old, have smoked cigarettes for at least 20 pack-years, and currently smoke or quit smoking within the past 15 years. In a prospective cohort at Nashville, Denver, Louisville, Chicago, Kansas City, Salisbury and Seattle Veteran Affairs medical centers, the investigators will evaluate the detection of lung cancer using an expanded screening eligibility criteria based on Veterans' personal and service-related exposures compared to standard of care criteria. Screening a larger population will increase the number of lung nodules needing clinical management and these nodules may or may not be cancer. In a population of Veterans with positive screenings at Nashville, the investigators will also validate a combination biomarker-based approach to manage screen-detected lung nodules to reduce time to lung cancer diagnosis and use of invasive procedures. This study will also convene a Veteran Community Advisory Board and interview Veterans to better understand their thoughts about lung cancer screening and preferences for outreach and engagement.