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NCT07646587
This study is trying to identify the right dose of a long-acting medicine called WIN378 for people with moderate - severe chronic obstructive pulmonary disease (COPD). WIN378 blocks the action of a protein called TSLP that causes inflammation in the lung and may contribute to COPD control and symptoms. The study will test how doses of WIN378 are handled by the body (pharmacokinetics) and assess the safety of the medicine and markers of COPD inflammation in exhaled breath and blood, lung function and COPD control (pharmacodynamics)
NCT07563283
Why is this study being done? Chronic Obstructive Pulmonary Disease (COPD) causes airflow blockage creating breathing issues, distress, and lower well-being. COPD also causes hyperinflation of the lungs. The investigators are doing the study to learn more about improving lung function for patients with COPD by using voice-based experiences. What is being tested in this study? If singing/vocalizing can improve lung function. How long will I be in the study? The study will last 4 weeks and involve 2 in-person visits to KUMC with virtual vocal sessions two times a week over Zoom.
NCT07207967
In patients with airflow obstruction receiving mechanical ventilation, an important objective is to reduce lung hyperinflation often using controlled hypoventilation. At the same time, maintaining acceptable gas exchange is challenging, as major reductions in minute ventilation (VE) raises carbon dioxide (CO2) and causes respiratory acidosis, which may lead to adverse physiological consequences. Relatively prolonged end-inspiratory pause (EIP) has been shown to optimize CO2 clearance in hypoxemic mechanically ventilated patients. Previous data suggests that, at equivalent total inspiratory-time (TI), shorter insufflations followed by EIP can enhance CO2 elimination in acute lung injury. Adding EIP is classically discouraged in chronic obstructive pulmonary disease (COPD) because - at constant respiratory rate (RR) - prolonging inspiration reduces expiratory time (TE), and can worsen hyperinflation and impair hemodynamics. In this study, we assessed whether a breathing pattern characterized by high inspiratory flow (V ̇) plus EIP could reduce PaCO2 without inducing hyperinflation, compared with same inspiration-to-expiration time (I:E) and a ventilation pattern without EIP in patients with COPD undergoing controlled hypoventilation. Methods We performed a prospective, single-center, cross-over, randomized trial (ethical approval #10/2024) including deeply sedated and intubated adults with COPD exacerbation, PaCO2 ≥ 45 mmHg and no signs of respiratory effort. Persistent air-leaks, severe hemodynamic instability, pregnancy or intracranial hypertension were exclusion criteria. Patient's next of kin signed the informed consent. At inclusion, we collected demographic characteristics and baseline respiratory variables. A CT-emphysema score, using computed tomographies obtained within 24 hs of intubation for clinical reasons, was calculated (A.R, a pulmonologist specialized in medical imaging). Each lung was divided into 3 regions (superior, medium and inferior) based on anatomical references and were graded as no emphysema (score 0), emphysema ≤25% (score 1), ≤50% (score 2), ≤75% (score 3) and \>75% (score 4). Scores of the six regions were summed to obtain the total score, giving a minimum 0 and a maximum of 24 points. Total scores ≥ 2 are indicative of emphysema. Patients were ventilated in volume-controlled mode with square-flow waveform, tidal volume of predicted body weight (VtPBW) 6-8 ml/kg, TI 0.6-0.8 seconds, RR 10-16 breaths per minute (bpm) and I:E relationship 1:4-1:8. External positive end-expiratory pressure (PEEPext) was set to the maximum value that did not increase plateau pressure (Pplat) ≥ 1cmH2O compared to zero PEEP, and FiO2 to maintain oxygen saturation of 90-95%. Two ventilation strategies, each one applied for 30 minutes, were randomly evaluated: a) ventilation without EIP, using initial ventilator settings (VentNO-PAUSE); b) ventilation with EIP (VentPAUSE), in which V ̇ was increased and 40-50% of the total inspiratory time (TI) was replaced by EIP; the remaining setting were equal to VentNO-PAUSE. At the end of each phase, we collected arterial blood gases, respiratory mechanics and basic hemodynamics. Total PEEP (i.e., PEEPtot=PEEPext + autoPEEP) and Pplat were assessed with 5-second end-expiratory, and 2-second end-inspiratory occlusions, respectively. Driving airway pressure (ΔP) was computed as Pplat - PEEPtot, normalized elastance (ERS-n) as driving pressure (ΔP)/VtPBW and inspiratory airway resistance (Raw) as (Peak pressure \[Ppeak\] - Pplat) / V ̇. We hypothesized that ventilation efficiency would be better during VentPAUSE, and wanted to evaluate whether this strategy would have allowed to reduce VE while keeping the same CO2 obtained without EIP. Accordingly, and assuming a constant CO2 production, we calculated the predicted VE during VentPAUSE to maintain the same CO2 measured during VentNO-PAUSE with the formula : Predicted VE\_( (Vent\_PAUSE))=█(〖PaCO\_(2 )〗\_((Vent\_PAUSE ) ) )/〖PaCO\_2〗\_((Vent\_(NO-PAUSE) ) ) × VE used during the study phases. This allowed to calculate to what extent it would have been possible to reduce VE (VEpred) and RR (RRpred) using the experimental strategy. We additionally calculated the predicted prolongation of expiration using the new RRpred as: TE-pred = (60/RRpred) - TI. We calculated the ventilatory ratio as an indice reflecting physiological dead-space ventilation (VD/VT).
NCT07112235
The goal of this study is to examine exacerbations of chronic obstructive pulmonary disease (COPD) caused by a common cold virus called rhinovirus, to identify new treatments. Exacerbations are flare-ups of respiratory symptoms which are a major cause of ill health in people with COPD, and are most commonly caused by viruses. The main questions the study aims to answer are: * What processes in the body occur in response to rhinovirus infection, and do the differences between people with COPD and healthy volunteers explain why people with COPD develop more severe illness and exacerbations? * Can treatments be identified that target these processes to reduce the severity and frequency of exacerbations in people with COPD? The study will compare eligible participants with COPD to healthy volunteers, and will involve intentionally infecting each participant with rhinovirus in a controlled environment. They will undergo baseline investigations prior to infection including a first bronchoscopy. Post-infection each participant will undergo a range of tests, including a second bronchoscopy, to compare how processes in the body, and especially the lungs, differ between people who do and do not have COPD.
NCT07343375
Patients with chronic obstructive lung disease (COPD) suffer from a progressive loss of lung function that leads to poor quality of life, and often invalidity and early death. Regular exercise can improve quality of life in these patients, but there is a lack in understanding the underlying mechanism of exercise-induced improvement in COPD and it is widely thought not to have any effect on the lung as such. In the present study, the investigators aim to investigate the impact of an extensive high-intensity interval training (HIIT)-based exercise scheme on the regenerative capacity of the lung in patients with COPD on waiting list for lung volume reduction surgery. Design: Prospective randomized controlled clinical trial. Intervention: 24 persons with COPD referred for lung volume reduction surgery will randomly be allocated (1:1) to prehabilitation with high intensity interval training (HIIT) or non-exercise control. Outcomes: The primary outcome is differences in change in differential protein composition in distal lung tissue between HIIT and control groups post-intervention using spatial multimodal proteomics. Furthermore, lung tissue mass, protein composition (mass spectrometry and spatial omics e.g. MACSima), pulmonary blood volume, blood protein profile (biomarkers), diffusion capacity at rest and during exercise, oxygen consumption tests, body composition scan, distal airspace radii and physical functional tests will be measured before and after the intervention. Perspective: This study may fundamentally change the view on the regenerative potential of the lungs in COPD.
NCT07472530
Purpose: This study evaluated the impact of a structured intervention on frailty, lung function, physical capacity, and dyspnea in elderly COPD patients. COPD, common in older adults, often coexists with frailty, which worsens health outcomes. While pulmonary rehabilitation improves function, its effect on frailty remains unclear. Procedures: A total of 66 patients with a confirmed diagnosis of COPD were randomly allocated into two equal groups: an intervention group (n=33) and a control group (n=33). Participants in the intervention group completed a six-week pulmonary rehabilitation program. Both baseline and post-intervention evaluations comprised spirometric measurements (FVC, FEV1, FEV1/FVC ratio, FEF25-75, and PEF), the Edmonton Frailty Scale (EFS), the six-minute walk test (6MWT), oxygen saturation levels, and assessments of dyspnea severity. Results: Significant improvements were observed in the intervention group in FVC, FEV1, FEV1/FVC, and PEF (p\<0.05). Total EFS scores and subdimensions such as mood, general health, and cognitive status also improved significantly (p\<0.05). Additionally, the intervention group showed increased 6MWT distance, higher oxygen saturation, and reduced dyspnea scores post-intervention (p\<0.05), with minimal changes in the control group. Conclusion: The findings suggest that pulmonary rehabilitation not only enhances pulmonary function and exercise capacity but also reduces frailty severity in elderly COPD patients. Integrating frailty-focused strategies into routine COPD management may improve outcomes and quality of life in this population.
NCT07469904
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.
NCT07450482
The purpose of this Phase IIa study is to evaluate the safety, efficacy, and pharmacokinetics of JKN2304 Inhalation Solution in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). The study is a multicenter, randomized, double-blind, placebo-controlled, and active-controlled (open-label) trial. Participants are randomized to receive JKN2304 (2 mg once daily or 2 mg twice daily), Placebo, or Formoterol Fumarate Inhalation Solution for a treatment period of 14 days.
NCT06717659
This study aims to investigate various aspects of patients with chronic respiratory diseases undergoing pulmonary rehabilitation supplemented with probiotics. The focus will be on clinical physiological responses, functional performance, respiratory status assessments, nutritional status evaluations, body composition analyses, and biochemical blood parameters, with a primary emphasis on the anti-inflammatory response.
NCT07363980
The Coronary Computed Tomography Angiography in Rheumatoid Arthritis study is part of the multinational, prospective, observational Autoimmunity and Atherosclerosis in Rheumatic Diseases cohort (https://atacc-rd.com) that includes comprehensive baseline and follow-up assessments at 3, 5, and 10 years. It comprises a main protocol and several optional modules, including a Cardiac Imaging Module, Biobanking Module, Pulmonary Module, and Anxiety and Depression Module. The study aims to advance understanding of cardiopulmonary and psychological comorbidities in rheumatoid arthritis, to improve early identification and management, and to enhance insights into underlying disease mechanisms-ultimately refining risk stratification and targeted prevention strategies. The study includes 4,000 patients with rheumatoid arthritis enrolled through the Cardiac Imaging Module in the main protocol. Participants undergo coronary computed tomography angiography, pulmonary function testing, physical examination, questionnaires, and biobanking, supplemented by genetic, proteomic, metabolomic, and microbiome profiling.
NCT07134400
Chronic Obstructive Pulmonary Disease (COPD) is a pathology characterized by progressive bronchial obstruction associated with an abnormal inflammatory response, leading to chronic cough, increased bronchial secretions, and irreversible destruction of alveolar walls according to the French-Language Pulmonology Society, in 2023, over 1.3 million patients were treated for this condition in France. The World Health Organization ranks COPD as the third leading cause of mortality worldwide. Historically, COPD predominantly affected men due to higher smoking rates. However, with the rise in smoking among women, recent studies have shown that the prevalence of COPD in women increased from 28 to41 perr 10,000 between 2006 and 2015. Moreover, the clinical presentation of the disease differs between genders. For equivalent smoking exposure, women appear to be more severely affected than men, experiencing greater dyspnea and a higher risk of exacerbations, leading to more frequent hospitalizations and a generally poorer quality of life. Beyond pulmonary impairment, another clinically significant but often underestimated symptom affecting quality of life is urinary incontinence. It appears more common in individuals with COPD, particularly due to chronic cough, repeated abdominal hyperpressure, and pelvic floor muscle imbalance. A few studies have investigated the prevalence of urinary incontinence in people with COPD. One study, involving 995 individuals with COPD, suggested that 34.9% experienced urinary leakage. However, this was a subjective measure based on self-reported data via a simple questionnaire in a case-control study. Another Swedish study estimated the prevalence of urinary incontinence in individuals with COPD at 49.6% in women and 30.3% in men, indicating that women may be at higher risk of developing this symptom. Beyond these studies, the current scientific literature remains relatively limited on this topic, while the impact on patients' quality of life appears to be significant. Among the available studies, one of the most comprehensive was published in 2013 and relied solely on self-administered questionnaires distributed to a broad population (across all disease stages) outside the rehabilitation setting. This overlapping symptomatology-combining COPD and urinary incontinence-profoundly affects patients' quality of life, physically, psychologically, as well as socially. The consequences include limited activities, social withdrawal, diminished self-esteem, and persistent discomfort in daily interactions. This situation can lead to social anxiety or fear of leakage, resulting in absenteeism or abandonment of pulmonary rehabilitation sessions, thereby compromising the effectiveness of treatment. Reduced participation in physical activity perpetuates a vicious cycle: muscle deconditioning, sarcopenia, or even malnutrition, which worsens dyspnea, loss of autonomy, and increases the risks of frailty, infections, and hospitalizations. The study by M. A. Ramon et al. (2018) illustrates this "vicious cycle," where impaired respiratory and physical capacities are self-sustaining. Without specific screening or management strategies for urinary incontinence in this context, breaking this downward spiral and improving overall care trajectories becomes challenging. Raising awareness about the importance of screening for stress urinary incontinence in women with COPD-particularly during pulmonary rehabilitation sessions, where these symptoms are often overlooked due to lack of knowledge and available treatments-is crucial. Such screening would enhance our understanding of the link between chronic cough, stress urinary incontinence, and quality of life. Establishing a correlation between these factors would allow for tailored care pathways and referral of certain patients to targeted pelvic floor rehabilitation. A better understanding of this phenomenon is essential to improve functional assessment and propose adapted therapeutic approaches, which could be the subject of an interventional study in the future. This study thus represents an initial exploratory step aimed at better understanding the prevalence of urinary incontinence in women with COPD undergoing rehabilitation, as well as its impact on quality of life and cough function. It is a preliminary, observational study whose results will lay the foundation for future interventional research.
NCT07076290
The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-3750) in patients with mild to moderate chronic obstructive pulmonary disease (COPD)
NCT07365943
This study aimed to examine the effect of forgiveness-based motivational interviewing on death anxiety, life satisfaction, and forgiveness disposition in patients with COPD. A randomized controlled experimental design with pretest, posttest, and one-month follow-up measurements was employed. The study sample consisted of 30 patients (experimental group: 15; control group: 15). The experimental group received forgiveness-based motivational interviewing, whereas no intervention was provided to the control group. Data were collected using a personal information form, the Death Anxiety Scale, the Life Satisfaction Scale, and the Forgiveness Scale. The findings revealed that, in the posttest and follow-up measurements, the experimental group had significantly lower mean scores on the Death Anxiety Scale compared to the control group (p\<0.05). Furthermore, the experimental group demonstrated significantly higher mean scores on the Life Satisfaction Scale and the Forgiveness Scale in the posttest and follow-up measurements than the control group (p\<0.05). This study concluded that forgiveness-based motivational interviewing effectively reduces death anxiety while enhancing life satisfaction and forgiveness disposition in patients with COPD. Therefore, implementing motivational interviewing for patients is recommended.
NCT06544928
Strados Labs has developed the Strados™ Respiratory Care Platform, including the RESP™ Biosensor System, which encompasses a clinically validated wearable, non-invasive, Bluetooth-enabled device capable of remotely collecting respiratory data. RESP was designed to extend both the geographical and temporal range of lung sound recordings, which can improve the remote monitoring of high-risk COPD patients. The RESP Biosensor continuously captures lung sounds and chest wall motions that are wirelessly transmitted through a mobile app to a web application to be analyzed for changes in respiratory health. Preliminary data suggest good patient compliance and the potential for RESP to detect early COPD exacerbation. However, uncertainty on the optimal RESP monitoring procedure and insufficient longitudinal RESP data for definitive statistical correlation with COPD exacerbations warrant further study. We plan to conduct an observational study to assess feasibility of home RESP remote patient monitoring and secondarily collect the longitudinal data necessary to establish the correlation between RESP based measures and standard of care measures of COPD symptom severity.
NCT07314242
A Multicenter, Randomized, Double-blind, Single-dummy, positive drug and placebo-controlled, Parallel Group, Phase 2a Study to Evaluate the Efficacy and Safety of Hemay005 in Adults with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD).
NCT06615492
Lung transplantation is a complex procedure performed in patients with terminal lung disease. The transplant procedure stresses the patient's heart and lungs, which are already taxed by the underlying disease process. The heart-lung machine is occasionally used to support the patient and ensure adequate oxygen supply to other organs during the operation. It can be used routinely in all patients or selectively in patients who exhibit reduced oxygen supply to the remaining organs. This process, known as cardiopulmonary bypass (CPB), pumps blood out of the body to a heart-lung machine that removes carbon dioxide and returns oxygen-filled blood to the body. Although using the CPB increases the risk of bleeding, infection, and coagulation complications, it should still be considered in high-risk patients to compensate for more severe complications such as kidney failure and stroke caused by a lack of cardiopulmonary support. Extracorporeal membrane oxygenation (ECMO) is a recently developed CPB variation associated with fewer bleeding complications. It has recently replaced the traditional heart-lung machine as the preferred method of cardiopulmonary support during lung transplantation. Since ECMO is associated with fewer complications than standard CPB, many centers have increased their use of ECMO during lung transplantation. Some have even employed it routinely. However, there remains significant debate on how often it should be used. Therefore, the study's main objective is to compare the two approaches in lung transplantation, i.e., routine use versus selective use, and to determine if one approach is preferable to the other.
NCT07261293
Purpose: This study aims to compare the effects of the classical pulmonary rehabilitation (PR) program and blood flow restriction (BFR) applied during low-intensity aerobic exercise within PR on systemic inflammation, hypoxemia, exercise capacity, pulmonary function, respiratory muscle strength, and quality-of-life parameters in individuals with COPD. Methods: This randomized controlled study will include 34 individuals with COPD, allocated into a BFR aerobic group and a control group. Both groups will receive core PR components, including diaphragmatic breathing, pursed-lip breathing, respiratory muscle training, and peripheral muscle strengthening. The BFR group will perform low-intensity aerobic exercise with blood flow restriction, while the control group will perform moderate-intensity aerobic exercise without BFR in accordance with standard PR protocols. All sessions will be supervised by a physiotherapist, twice per week, for eight weeks. Systemic inflammation markers, arterial blood gases, pulmonary function, exercise capacity, quality of life, and symptom scores will be assessed before PR, after the 8th session, and at the end of the program. Data will be analyzed using SPSS 26.0. Expected Contribution: This study aims to provide evidence-based insights into the physiological and clinical effects of low-intensity BFR aerobic exercise within PR and to determine its potential advantages compared with classical PR. Additionally, it seeks to clarify whether low-intensity BFR aerobic exercise may serve as a better-tolerated alternative for COPD patients who experience exercise intolerance during moderate-intensity aerobic training.
NCT07267858
The main objective of this study is to evaluate the effects of a Clinical Pilates-based exercise programme on chest mobility, lung function, motor performance, physical activity levels, sleep quality and Health-Related Quality of Life (HRQoL) in individuals with Gold A COPD. Based on our research question, 'What is the effect of a Clinical Pilates programme on thoracic mobility, pulmonary function, motor performance, physical activity levels, sleep quality, and HRQoL in people with Gold A COPD?', we propose the following research hypotheses: H1: The Clinical Pilates programme contributed to improved thoracic mobility in people with Gold A COPD. H2: The Clinical Pilates programme contributed to improved lung function in people with Gold A COPD. H3: The Clinical Pilates programme positively influences the motor performance of people with Gold A COPD. H4: The Clinical Pilates programme positively influences the physical activity levels of people with COPD Gold A. H5: The Clinical Pilates programme positively influences the sleep quality of people with COPD Gold A. H6: The Clinical Pilates programme contributes to improving the HRQoL levels of people with COPD Gold A.
NCT07262905
This prospective observational clinical study investigates two key questions in COPD patients undergoing sedated endoscopic procedures. The first is whether respiratory deterioration that may occur during the procedure is associated with clinical risk indicators such as symptom burden, prior exacerbations, and previous hospitalizations. The second is to assess the effectiveness of the Integrated Pulmonary Index (IPI) in predicting this deterioration, and to compare its performance with traditional respiratory monitoring parameters including oxygen saturation (SpO₂) and capnography (EtCO₂). The study hypothesis is that respiratory deterioration is linked to clinical risk indicators and that the IPI will demonstrate superior predictive accuracy compared with classical monitoring parameters. All participants will belong to a single COPD cohort and will not be assigned to different intervention arms. For analysis, patients will be categorized based on whether clinical interventions-such as increased oxygen flow, repositioning, or respiratory support-become necessary during the procedure. This classification reflects routine clinical care, and no additional interventions are performed as part of the study.
NCT07261813
Chronic obstructive pulmonary disease (COPD) is characterized by airflow limitation that is not fully reversible. The study "Quality of life among people living with Chronic Obstructive Pulmonary Disease- visiting spirometry center of Tribhuvan University Teaching Hospital, Kathmandu Nepal" aims to assess the quality of life (QOL) of COPD patients and the factors affecting it. A cross sectional study will be performed among the patients visiting Spirometry center of Tribhuvan University Teaching Hospital, Kathmandu Nepal using Convenience Sampling. Ethical approval will be obtained from Institutional Review Board (IRB) of TUTH and written/verbal consent for data collection will be obtained from Teaching hospital authority as well as the respondents. CAT questionnaire will be used to assess quality of life and the Medical Research Council questionnaire will be used to assess the severity of dyspnea. Data management and analysis will be conducted through Statistical Package for Social Sciences (SPSS) version 26.0.