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NCT07192705
Nontuberculous mycobacteria (NTM) are environmental organisms found in soil and water. The majority do not cause human disease. When they do, this is mostly as a chronic lung infection in people with long-term lung problems such as chronic obstructive pulmonary disease (COPD), bronchiectasis, or cystic fibrosis. The number of people with NTM pulmonary disease (PD) is increasing, and its management can be complex, requiring prolonged treatment with multiple, often toxic, drugs in someone who may already be frail. Non-drug approaches, such as airway clearance techniques, structured exercise, nutritional support and psychological care are used to help manage bronchiectasis and COPD. However, there is limited evidence about their benefit in people with NTM-PD. Also, it is not clear whether these patients' health needs are different from people with bronchiectasis alone. The investigators want to identify the most important symptoms encountered by people with NTM-PD and patient preferences for care. The study also aims to explore whether the need for non-drug measures differs between people with and without NTM-PD who have other underlying lung disease. The research will take place at one NHS centre and involve a single assessment of 40 people with NTM-PD not using specific antibiotics to treat their NTM and 40 people with bronchiectasis but no evidence for NTM. Following consent, and mainly using questionnaires, participants will be asked about their physical and mental health, and nutritional status. Exercise capacity, muscle strength and body muscle/fat composition will also be assessed using simple tests. The total time required will be a maximum of one hour. Recruitment to the study will last around six months. The results will help improve understanding of specific needs of people with NTM-PD and guide clinically relevant research in this area.
NCT07579052
This prospective observational cohort study aims to prospectively evaluate and validate the Clinical Load, Exchange, Ability of Respiration, and Reserve (CLEAR) model for predicting sustained ventilatory liberation in patients with severe chronic obstructive pulmonary disease (COPD) receiving invasive mechanical ventilation (MV) or non-invasive ventilation (NIV). Two parallel cohorts will be studied: CLEAR-MV for patients undergoing spontaneous breathing trials (SBT) and CLEAR-NIV for patients undergoing NIV withdrawal trials. The model integrates diaphragm ultrasound evaluating diaphragm thickening fraction (DTF), ventilatory load indices including the rapid shallow breathing index (RSBI) or Clinical Load Index (CLI), gas exchange parameters including Potential of Hydrogen (pH), partial pressure of carbon dioxide (PaCO₂), and its change over time (ΔPaCO₂) combined as the Gas Exchange Index (GEI), and peripheral muscle reserve assessing rectus femoris (RF) and vastus intermedius (VI) thickness. The primary outcome is successful liberation from ventilatory support within 72 hours. Secondary outcomes include ventilatory failure within 7 days, ventilator- or NIV-free days at 28 days, and time-fixed 90-day clinical outcomes including all-cause mortality, sustained ventilatory independence, and rehospitalization for respiratory failure. Model performance will be evaluated using discrimination (area under the receiver operating characteristic curve), calibration (calibration intercept and slope), and clinical utility (decision curve analysis and net benefit) and compared with prespecified established ventilatory indices, including the Rapid Shallow Breathing Index (RSBI) and Integrative Weaning Index (IWI) in the invasive mechanical ventilation cohort, and the Heart rate, Acidosis, Consciousness, Oxygenation, and Respiratory rate (HACOR) score and the ratio of peripheral oxygen saturation to fraction of inspired oxygen divided by respiratory rate (ROX) index in the non-invasive ventilation cohort.
NCT06847061
The purpose of this study is to test the uptake, effectiveness, and patient-caregiver-provider experience of a crucial treatment not provided in rural areas: pulmonary rehabilitation.
NCT05061368
Chronic obstructive pulmonary disease (COPD) is a condition characterized by airway obstruction. Patients with COPD experience significant shortness of breath on exertion. The mechanisms responsible for shortness of breath on exertion are well understood in moderate and severe COPD, but, are poorly understood in mild COPD where symptoms appear disproportionate to the degree of airway obstruction. Mild COPD patients show an exaggerated breathing response to exercise, determined by the breathing response to carbon dioxide production (V̇E/V̇CO2). Recent work suggests that the increased V̇E/V̇CO2 during exercise in mild COPD is secondary to increased deadspace (i.e. lung regions with ventilation but no perfusion) and/or ventilation/perfusion (V̇A/Q) inequality (poor matching of ventilation to perfusion). Researchers have proposed that the increased deadspace or V̇A/Q inequality is secondary to pulmonary vascular dysfunction and hypoperfusion of the pulmonary capillaries. Recently, we have shown that inhaled nitric oxide, a potent dilator of pulmonary vasculature, reduces shortness of breath and V̇E/V̇CO2, and improves exercise capacity in mild COPD. This preliminary finding suggests that pulmonary vascular dysfunction is an important contributor to exercise intolerance in mild COPD. Here, we aim to test whether sildenafil, an oral pulmonary vasodilator, can improve exercise tolerance and shortness of breath in mild COPD.
NCT06511193
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.
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.
NCT05940480
Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable disease. The aim of prospective randomized study is to evaluate the effects of TCM Daoyin training on Individuals at-risk for COPD.
NCT07482033
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.
NCT05607719
The study objective is to determine whether an ICS added for 4 weeks to a baseline treatment with a Long-Acting Beta-adrenergic Agonist (LABA) and Long-Acting Muscarinic Antagonist (LAMA) combination improves pulmonary vascular endothelial function as assessed by the vasodilator response to inhaled albuterol (endothelium-dependent vasodilation) in stable COPD patients treated with a LABA/LAMA without an ICS for at least one month.
NCT05759247
The purpose of this study is to evaluate the ability of the Bora Care remote monitoring solution to detect early acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD).
NCT07190209
This is a parallel, Phase 2b/Phase 3, 3-arm study to investigate the efficacy, safety, and tolerability of subcutaneous (SC) treatment with lunsekimig compared with placebo in adult participants (aged 40 to 80 years, inclusive) with inadequately controlled Chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype. Participation to the study consists of 3 periods: * Screening period of up to 4 weeks * Randomized intervention period of approximately 48 weeks * Follow-up period: Approximately 8 weeks The study duration will be up to 60 weeks.
NCT06712563
The CHOROS pooled analysis is a retrospective secondary data use analysis of integrated individual participant data from a series of planned and on-going primary prospective, non-interventional, multi-center studies sponsored by AstraZeneca and conducted in the pulmonary/primary care practitioner setting in multiple countries and may include data from the following countries: United Kingdom, Germany, Italy, Greece, Japan, Canada and Romania.
NCT05746039
The goal of this clinical trial is to learn whether semaglutide, an FDA-approved treatment for diabetes and obesity, is feasible and tolerable in patients with advanced lung disease. The main question\[s\] it aims to answer are: 1. Are patients with advanced lung disease able to tolerate semaglutide therapy? 2. Are we able to titrate semaglutide therapy to a target weight? Participants will be asked to perform pulmonary function, physical function and body composition testing, as well as a blood draw before and after 12-weeks of semaglutide therapy. While on therapy, subjects will be surveyed regarding any adverse events or side effects.
NCT07307781
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
NCT04700098
This study is a randomized controlled trial (RCT) to compare sleep and health-related functioning in Veterans with chronic obstructive pulmonary disease (COPD) and insomnia receiving an Internet-based behavioral treatment for insomnia versus online insomnia patient education. Participants will undergo a sleep and health assessment that will be performed at baseline, post-treatment, and 3-months later. Participants will be randomly assigned to either Internet-based behavioral treatment for insomnia or online insomnia patient education.
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).
NCT07073950
The purpose of the study is to evaluate the effect of BGF MDI compared with placebo MDI on cardiac and lung function when administered in participants diagnosed with COPD and hyperinflation.
NCT04701983
Primary Objective: Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD Secondary Objectives: * Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD * Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD * Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD * Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD
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.
NCT02556697
Systemic sclerosis (SSc) is a generalized disorder of connective tissue, arterioles and microvessels, characterized by the occurrence of fibrosis and vascular obliteration phenomena. The alterations in lung microvessels are found in pulmonary involvement of scleroderma, which are the most serious complications of the disease. In pulmonary emphysema, there are also changes in pulmonary microvasculature, which are involved in the onset and development of the disease. The confocal endomicroscopy is an endoscopic technique which can be performed during a bronchoscopy. This technique makes it possible to observe in real time the most distal pulmonary elements at the microscopic scale. After injection of fluorescein, then the technique of observing the pulmonary microvasculature, in vivo and in situ. The characterization of microvascular lesions in these two pathologies could improve understanding of their mechanisms and ultimately improve the early management of patients.