Clinical Research Directory

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 Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

This study will evaluate the efficacy and safety of astegolimab compared with placebo in participants with chronic obstructive pulmonary disease (COPD) who are former or current smokers and have a history of frequent exacerbations.

Predicting Dynamic Inspiratory Muscle Strength in COPD and Asthma Patients

This observational study evaluates whether dynamic inspiratory muscle strength can be estimated in patients with chronic obstructive pulmonary disease (COPD) and asthma using simple clinical and performance-based measurements. Dynamic inspiratory muscle strength was assessed using the S-Index, which reflects the pressure generated during a fast and forceful inspiration while airflow is maintained. The study included adult male patients diagnosed with COPD or asthma. Participants completed respiratory muscle strength assessment, pulmonary function testing, body composition assessment, and a fixed-pressure inspiratory muscle performance test using a threshold loading device set at 30 cmH₂O. The number of inspiratory repetitions performed until task failure and related respiratory variables were recorded. The main aim of the study was to develop prediction models for estimating S-Index values from accessible measures such as peak inspiratory flow, inspiratory repetition performance, spirometry parameters, and body composition variables. The study may help determine whether dynamic inspiratory muscle strength can be estimated in clinical settings where direct S-Index measurement devices are not available.

Feasibility Study of a Digital Interactive Life-style Platform for Individuals After Rehabilitation

The goal of this clinical trial is to evaluate the feasibility and usability of a digital lifestyle platform designed to support patients after discharge from inpatient rehabilitation. It will also assess patient engagement and the potential of the platform to support long-term self-management and healthy lifestyle behaviors in an outpatient setting. The main questions it aims to answer are: Is the platform feasible and acceptable for patients after rehabilitation? Do patients engage with and regularly use the platform over time? Can personalized digital recommendations support adherence to healthy behaviors and self-management? Researchers will evaluate a telemedicine platform that delivers individualized suggestions, including lifestyle applications, educational content, and advice from healthcare professionals. The content is tailored to patient needs and continuously adapted based on patient feedback. Participants will: Use the digital platform after discharge from inpatient rehabilitation for a defined follow-up period Receive personalized recommendations through the platform Rate the usefulness of recommendations to enable continuous adaptation Attend study visits or remote assessments to evaluate usability, engagement, and outcomes Continue standard outpatient care alongside the intervention

Pilot Study on Mindfulness Based Stress Reduction (MBSR) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This two-phase exploratory pilot study investigates the impact of a Mindfulness-Based Stress Reduction (MBSR) program on patients with chronic obstructive pulmonary disease (COPD) undergoing pulmonary rehabilitation. Phase 1, conducted from 2015 to 2018, explored the potential clinical effects of the intervention. It included a mixed-gender intervention group and a control group composed exclusively of male participants. In the context of a doctoral research project, Phase 2 was initiated in 2024 to expand the control group by including female participants, thereby improving gender balance and ensuring more robust comparative clinical analysis. All participants were enrolled in a multidisciplinary outpatient pulmonary rehabilitation program at the time of inclusion. The aim of the study is to evaluate the potential effects of MBSR on psychological symptoms, disease-specific quality of life, perceived stress, and medication adherence in patients with COPD. The intervention consists of a standardized 8-week MBSR program developed by Jon Kabat-Zinn, including weekly 2.5-hour group sessions, one day-long silent retreat, and daily home practice (approximately 45 minutes per day). Participants are followed for 12 months. Clinical outcomes are assessed at baseline, post-intervention (10 weeks), 6 months, and 12 months and include: Anxiety and depression (Hospital Anxiety and Depression Scale - HADS) Disease-specific quality of life (Chronic Respiratory Questionnaire - CRQ) Perceived stress (Perceived Stress Scale - PSS) State and trait anxiety (State-Trait Anxiety Inventory - STAI, Spielberger) Medication adherence (Morisky Medication Adherence Scale - MMAS) This study contributes to the growing body of research supporting mindfulness-based interventions as complementary care within pulmonary rehabilitation for chronic respiratory diseases.

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.

Assessing and Improving Misuse of Inhalers in COPD Outpatients

Chronic obstructive pulmonary disease (COPD) is a common long-term lung disease that causes breathlessness, cough, and frequent flare-ups. Most patients with COPD use inhaled medications every day. However, many people do not use their inhalers correctly, or they cannot generate the right inspiratory flow for their device. When inhalers are used incorrectly, the medication does not reach the lungs properly, symptoms worsen, and the risk of exacerbations increases. This pragmatic randomized controlled trial evaluates whether a structured physiotherapist-led inhaler optimization program improves inhaler use in routine outpatient COPD care. The program is delivered by trained physiotherapists over 12 months and includes three in-person sessions. During these sessions, the physiotherapist evaluates the patient's inhaler technique using placebo devices, measures the patient's peak inspiratory flow with the In-Check DIAL® device, and provides individualized "teach-to-goal" education to help patients use their inhalers correctly. If the patient continues to make critical errors or cannot generate the appropriate inspiratory flow for their inhaler, the physiotherapist may recommend adapting the type of inhaler to better match the patient's abilities. Participants will be randomly assigned to one of two groups. The intervention group will receive the structured program in addition to their usual COPD care. The control group will continue with usual outpatient care without the physiotherapist-led sessions. All participants will complete baseline and 12-month assessments, which include inhaler technique evaluation, inspiratory flow measurement, respiratory questionnaires, and lung function tests. Telephone follow-up calls will be performed at months 2, 5, and 8 to monitor symptoms, inhaler use, and adherence. The main outcome of the study is the proportion of inhalers used incorrectly at 12 months. Incorrect use is defined as at least one critical inhaler technique error or an inspiratory flow that is too low or too high for the patient's device. Secondary outcomes include changes in respiratory symptoms, health status, adherence to inhaled treatment, patient satisfaction with inhalers, confidence in inhaler use, and the number of COPD exacerbations or hospitalizations during the study. This research may help improve everyday inhaler use in people with COPD and support more personalized inhaler selection in routine clinical care. Although participants may not benefit directly, the study poses minimal risks and may contribute to future improvements in COPD management.

Description of the Ability to Learn How to Handle Inhaler Devices in COPD

Chronic Obstructive Pulmonary Disease (COPD) is the fourth leading cause of death in the world and further increase in its prevalence and mortality has been predicted. Currently, the main long-term treatments are the long-acting beta-2 agonist, indacaterol, salmeterol and the anticholinergic drug, tiotropium and glycopyrronium, used alone or in combination: * long-acting beta-2 agonist with corticosteroid (e.g. salmeterol/fluticasone), * long-acting beta-2 agonist with anticholinergic (e.g. indacatetrol/glycopyrronium). These drugs are delivered to the lung using different inhaler devices such as Breezhaler ®, Handihaler® and Diskus®.

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)

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)

Effect of Pursed-Lip Breathing With Different I:E Ratios on Respiratory Outcomes in COPD Patients

The goal of this clinical trial is to evaluate whether different inspiratory-expiratory (I:E) ratios in the pursed-lip breathing (PLB) technique can improve respiratory outcomes in patients with stable Chronic Obstructive Pulmonary Disease (COPD) aged 40 years and older. The primary purpose is to determine whether a specific breathing intervention can improve respiratory function. The main questions it aims to answer are: Does PLB with different I:E ratios (1:3, 1:4, and 1:5) reduce respiratory rate in COPD patients? Does PLB with different I:E ratios improve oxygen saturation and reduce dyspnea severity? Researchers will compare PLB with I:E ratios of 1:3, 1:4, and 1:5 and a control group receiving standard care to see if different ratios produce different effects on respiratory rate, oxygen saturation, and dyspnea levels. Participants will: Perform pursed-lip breathing using assigned I:E ratios (1:3, 1:4, or 1:5) for 10 minutes Be assigned to either an intervention group or a control group (standard care) Have their respiratory rate measured before and after the intervention Have their oxygen saturation measured using a pulse oximeter Report their dyspnea level using the Modified Borg Scale before and after the intervention

Feasibility and Acceptance of SonoHeal for Airway Clearance and Preliminary Comparison With the Standard of Care

The proposed study is to gauge the early feasibility and acceptance of the SonoHeal device. The study will evaluate the usability of the SonoHeal prototype using well-established Human Factors Engineering methods recommended by the FDA. The investigators will also obtain a preliminary comparison with the standard of care ACT device, High Frequency Chest Wall Oscillation (HFCWO).

Chronicling the COPD Patient Journey and Change in COPD Symptoms, Quality of Life and Exacerbations Following Initiation of Budenoside/Glycopyrronium/Formoterol [BGF]

The CHRONICLES study will investigate the change in clinical and patient reported outcomes after six-months of treatment with Budenoside/Glycopyrronium/Formoterol \[BGF\] in a real-world setting.

Screening for Pulmonary Embolism Using Single-channel Electrocardiogram

It is a prospective, controlled, single-center, observational, non-randomized study. The study is planned to include at least 500 patients 18 years old and older (300 patients in the training sample and 200 patients in the test sample. The study will include all patients requiring exclusion of the diagnosis of acute pulmonary embolism. Patients will be examined according to clinical guidelines to confirm the diagnosis of pulmonary embolism (laboratory, clinical and instrumental). During the course of the study, the authors of the work do not interfere with the scope of the examination, which is caried out on patients in accordance with clinical guidelines. All patients included in the study will undergo electrocardiogramm (ECG) in standart lead I for 1 minute, followed by spectral analysis of the obtained data, which will be stored at the Remote monitoring center of Sechenov University without being linked to the personal data of patients. A spectral analysis of the electrocardiogram will be performed using a continuous wavelet transformation. The result of this study will be the identification of ECG parameters that will correlate with pulmonary embolism.

Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations

The purpose of this study is to investigate the safety and tolerability of Metformin and how it changes blood markers associated with aging in persons who have chronic obstructive pulmonary disease (COPD) who do not have diabetes.

The Impact of Training on Self-Efficacy, Symptom Level, and Activities of Daily Living

This study is a randomized, controlled experimental trial with a pretest-posttest design, conducted to evaluate the effects of Pecha Kucha-based education on self-efficacy, symptom level, and activities of daily living in individuals diagnosed with chronic obstructive pulmonary disease (COPD) receiving noninvasive mechanical ventilation support. The study will include two groups, and intergroup differences will be evaluated: 1. Control group 2. Intervention group Study Hypotheses H1: Pecha Kucha-based education on noninvasive mechanical ventilation (NIMV) support provided to individuals with chronic obstructive pulmonary disease (COPD) increases patients' self-efficacy levels. H2: Pecha Kucha-based education on noninvasive mechanical ventilation (NIMV) support provided to individuals with chronic obstructive pulmonary disease (COPD) reduces patients' symptom levels. H3: Pecha Kucha-based education on noninvasive mechanical ventilation (NIMV) support provided to individuals with chronic obstructive pulmonary disease (COPD) improves patients' activities of daily living.

Endothelial Dysfunction, Biomarkers, and Lung Function -Ancillary to MESA

The purpose of the MESA Lung Study is to assess the role of endothelial dysfunction and genetic susceptibility to subclinical COPD and emphysema.

Effect of Inspiratory Muscle Training on Diaphragm Function in COPD Patients

This study investigates the effect of threshold inspiratory muscle training on diaphragm thickness and diaphragm excursion, measured using ultrasonography, in patients with stable chronic obstructive pulmonary disease (COPD).

Lungs on Fire: Wildfire Smoke, Incident Diseases, Susceptible Populations, and Community Values in Canada

Wildfire smoke (WFS) is the leading climate-related risk in Canada and the main source of harmful air pollution. While short-term breathing problems caused by smoke are well known, there is limited knowledge on how repeated exposure contributes to long-term lung disease. This study is a controlled human exposure to varying concentrations of WFS in a safe setting. By comparing the effects of different concentrations, this research will improve understanding of health impacts, identify who may be most vulnerable to exposures, and explore biological changes that could lead to chronic illness.

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.

Potential of Interface Care Models to Deliver More Appropriate Care to Patients With Acute Medical Illness

Every country in the world is experiencing growth in both the size and the proportion of older persons. As a result of the changes, the profile and needs of people with medical illnesses have evolved. How care is delivered to patients has to keep pace with these changes, or patients will experience poor care at high cost and not have their needs met. A new model of care has emerged to meet these challenges: Acute Medical Unit. Despite considerable investment and popularity of this model, questions remain: (i) Who benefits most from this care model? (ii) How may these models be most effectively implemented for the best results? (iii) How effective are these models? Singapore is well-placed to answer these questions with its national healthcare system and excellent research institutions. The investigators plan to study how effective the model is by comparing patients with similar profiles exposed to both these care models compared to how hospital care is usually provided, looking for four differences: (i) how long patients stay in hospital, (ii) how often they use the emergency department (iii) quality of health (iv) cost. Additionally, the investigators seek to characterise patterns of health needs for this group of patients.

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 Dose 1 and Dose 2 administered subcutaneously (SC) in adult participants with symptomatic COPD and history of ≥ 2 moderate or ≥ 1 severe exacerbation of COPD in the previous 12 months. Participants should be receiving optimised treatment with maintenance inhaled therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) in stable doses throughout at least 3 months prior to enrolment.

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 Dose 1 and Dose 2 administered subcutaneously (SC) in adult participants with symptomatic COPD and history of ≥ 2 moderate or ≥ 1 severe exacerbation of COPD in the previous 12 months. Participants should be receiving optimised treatment with maintenance inhaled therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) in stable doses throughout at least 3 months prior to enrolment.

Evaluation of Nasal Biomarkers for Objective Assessment of Disease Severity in Respiratory Disorders

This research study is an observational, single site study quantifying expression of biomarkers of respiratory disease in nasal fluid using the ABEL microsampler device. The primary objective of this study is to compare biomarker expression between healthy controls and participants with respiratory disorders such as chronic obstructive pulmonary disorder (COPD), hayfever, chronic sinusitis, asthma and rhinitis.