Functional Strength Training and Neuromuscular Electrical Stimulation in Severe Acute Exacerbations...
Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseAcute Exacerbation of COPDChronic obstructive pulmonary disease (COPD) is highly prevalent and frequently punctuated by severe acute exacerbations (AECOPD), defined as a temporary worsening of symptoms which leads to hospitalisation. AECOPD result in physical inactivity, muscle weakness and decreased exercise capacity, which impacts negatively on patients' health status, and increases patients' susceptibility for new exacerbations and death. To date, light aerobic exercises, such as early mobilisation and low-intensity ambulation, have become part of standard of care during severe AECOPD. Nevertheless, additional strength training using neuromuscular electrical stimulation and functional exercises, which have been shown to prevent skeletal muscle dysfunction whilst inducing minimal stress in the ventilatory system, might be of added value to optimize patients' functional performance and symptoms during activities at discharge. Therefore, this randomized controlled trial aims to evaluate the effectiveness of additional functional strength training and neuromuscular electrical stimulation on top of standard of care during hospitalisation for an AECOPD to enhance functional performance, symptoms of dyspnoea and fatigue during activities, and readmission rate.
Study of Epetraborole in Patients With Treatment-refractory MAC Lung Disease
MAC Lung DiseaseTreatment Refractory MAC Lung DiseaseThis is a pivotal Phase 2/3, double-blind, placebo-controlled study of epetraborole + OBR (Optimized Background Regimen) versus placebo + OBR in patients with treatment-refractory MAC lung disease. This study will enroll adult patients with treatment-refractory MAC lung disease who meet all eligibility criteria (including clinical, radiographic, and microbiological criteria).
Efficacy of Early Inspiratory Muscle Training in Lung Transplanted Patients
Lung Transplant RecipientsMuscle Weakness3 moreLung transplantation is an effective therapeutic option in the end-stage of chronic respiratory diseases. Lung transplantation improves lung function in terms of capacity and volume. However, the transplanted patient still suffers from muscle weakness and exercise intolerance. In recent years, respiratory physiotherapy work has intensified in critically ill patients with respiratory muscle weakness and the application of inspiratory muscle training (IMT), which has been shown in several studies to increase inspiratory muscle strength (IMT), improve ventilation and reduce the sensation of shortness of breath. Despite this emerging evidence, inspiratory muscle training (IMT) is not standard practice in most ICUs around the world, nor is it included in a protocolised manner among the components of a pulmonary rehabilitation programme. Given the limited evidence, the investigators propose to conduct this randomised controlled clinical trial in lung transplant recipients. The study will compare two groups of transplanted patients, a control group that will follow the rehabilitation programme and standard medical care and another experimental group that will also perform inspiratory muscle training. This study aims to analyse the effect of IMT on inspiratory muscle strength, exercise capacity and quality of life in lung transplant patients.
A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing...
Lung DiseasesInterstitialThis study is open to adults with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs). People who have a form of PF-ILD other than Idiopathic Pulmonary Fibrosis (IPF) can join the study. If they already take nintedanib, they can continue treatment throughout the study. The purpose of this study is to find out whether a medicine called BI 1015550 helps people with PF-ILD. Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of BI 1015550 as tablets twice a day. Participants in the placebo group take placebo tablets twice a day. Placebo tablets look like BI 1015550 tablets but do not contain any medicine. Participants are in the study for up to two and a half years. During the first year, they visit the study site 10 times. Afterwards, they visit the study site every 3 months. The doctors regularly test participants' lung function. The results of the lung function tests are compared between the groups. The doctors also regularly check participants' health and take note of any unwanted effects.
Non-invasive Neustimulation and Respiratory Rehabilitation
Lung DiseasesIntroduction: Respiratory diseases are associated with high rate of morbidity and mortality in Brazil. Cardiopulmonary rehabilitation through respiratory muscle training, aerobic training and strengthening of upper and lower limbs emerges as one of the resources available for the treatment and monitoring of patients with respiratory diseases. To add in this perspective, the application of HD-tDCS induces significant neurophysiological and clinical effects in several body systems. Objective: To identify the chronic effects of non-invasive neurostimulation associated with the rehabilitation of patients with respiratory disorders. Material and methods: This is a pilot study, quantitative, clinical trial type, randomized and controlled, double blind. The sample will be composed by patients with respiratory diseases, aged above 18 years old. The study will consist of two groups: (1) HD-tDCS will be applied - anodic current + respiratory rehabilitation with respiratory muscle training (RMT) and (2) Sham - Only respiratory rehabilitation with RMT without any type of cortical stimulation. The chronic effects of neurostimulation by HD-tDCS associated with cardiopulmonary rehabilitation, with TMR, during 12 sessions will be evaluated. Patients will be evaluated, before and after the protocol, in relation to cortical activation function, pulmonary function, subjective perception of effort, respiratory muscle function, functional capacity, sensation of dyspnea and quality of life. For statistical analysis, intention-to-treat analysis will be used and groups will be compared using Student's t-test, for continuous variables, or chi-square, for categorical variables. ANOVA split-plot, repeated measures for primary outcomes. Analyzes of covariance to identify differences between groups using baseline scores as covariates. Effect sizes and confidence intervals will be calculated using eta squared (η²). Expected results: Neurostimulation would enhance the effects of respiratory rehabilitation and reduce the symptoms of patients with these diseases.
TCM Daoyin Therapy in Individuals At-risk for COPD
Chronic Obstructive Pulmonary DiseaseLung Diseases1 moreChronic 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.
A Mechanistic Study of Inhaled Nitric Oxide in COPD
Chronic Obstructive Pulmonary DiseasePulmonary HypertensionThere is a lack of effective treatments for chronic obstructive pulmonary disease (COPD) complicated with pulmonary hypertension. Previous studies have found that inhaled nitric oxide (iNO) can reduce pulmonary artery pressure and improve exercise capacity in COPD with pulmonary hypertension patients. However, the specific mechanism is unclear. The study aims to evaluate pulmonary ventilation/perfusion, pulmonary artery pressure, oxygenation, symptoms and quality of life in COPD with pulmonary hypertension patients after short-term treatment with iNO. Observing a series of pathophysiological changes caused by the treatment of pulmonary hypertension with iNO in COPD, the investigators hope to provide new theoretical basis and research ideas.
(Concerto) Study of BLU-451 in Advanced Cancers With EGFR Exon 20 Insertion Mutations
Lung Neoplasm MalignantCarcinoma21 moreThis is a Phase 1/2, open-label first-in-human study of the safety, pharmacokinetics (PK), pharmacodynamics, and anti-tumor activity of BLU-451 monotherapy and BLU-451 in combination with platinum-based chemotherapy (carboplatin and pemetrexed). All participants will receive BLU-451 on a 21-day treatment cycle.
Air as a Placebo: Increasing the Respiratory Performance of People With COPD Through Simple Expectations...
Chronic Obstructive Pulmonary DiseaseCOPD (Chronic Obstructive Pulmonary Disease) is a disease of the respiratory system characterised by irreversible airway obstruction of varying severity. The disease (known as COPD, Chronic Obstructive Pulmonary Disease) is progressive and is associated with a state of chronic inflammation of the lung tissue, which leads to a real remodelling of the bronchi causing a significant reduction in airway flow. Among the possible treatments, while the placebo is considered as an inert treatment, lacking any intrinsic therapeutic properties, there is evidence in the literature that not all placebos are equivalent and some are more effective than others, as for example in the case of migraine or osteoarthritis. The differences found between different types of placebos (e.g. oral, subcutaneous, intra-articular...) indicate that placebos are not inert but rather consist of multiple psychosocial elements that are part of the ritual of the therapeutic act. This is also the context for the studies by Lacasse et al. (for the International Nocturnal Oxygen (INOX) Research Group et al., 2017) and Jarosh et al., who investigated the effects of oxygen therapy both during sleep and during the course of daily life, studying its influences through the use of placebo in patients suffering from hypoxemia. However, in the literature, there are no studies investigating the role of oxygen (O2) during the performance of a test such as the Walking Test, otherwise known as the 6 Minute Walking Test (6MWT) compared with a placebo in patients with Chronic Obstructive Pulmonary Disease (COPD), nor whether the use of the latter would lead to comparable results.
A Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants...
Pulmonary HypertensionThe primary objective of this study is to evaluate the safety and tolerability of treprostinil palmitil inhalation powder (TPIP) compared with placebo