View clinical trials related to Lung Diseases, Obstructive.
Filter by:In this project, Institute of Bioengineering & Bioimaging (IBB), A*STAR would like to collaborate with Massachusetts General Hospital to aggregate patient data and to further develop its software algorithm using machine learning and statistical models for predicting exacerbations and deterioration on 60 patients with cardiopulmonary diseases.
Chronic obstructive pulmonary disease (COPD) is a public health issue due to its prevalence of 8% in the general population (although it is underestimated), particularly due to the number of severe patients suffering from chronic respiratory failure and the number of hospitalizations estimated at 100,000 each year. Total health insurance expenditure in 2017 for chronic respiratory diseases (excluding cystic fibrosis and cancers) was approximately €3.5 billion, including €1 billion for hospitalizations. Hospitalizations are mainly related to a worsening of the disease (severe exacerbations mainly of viral and/or bacterial origin). Although the majority of exacerbations are treated on an outpatient basis with antibiotics and/or oral corticosteroids, those occurring in the most severe and often the oldest patients may require hospitalization. It should be noted that almost one out of two patients hospitalized for COPD exacerbation is re-hospitalized within six months; on the other hand, age and length of stay are the two main factors of mortality in the year following hospitalization for COPD in the Intensive Care Unit. Early detection of a worsening of the health status related to COPD could allow appropriate management and avoid at least part of the hospitalizations for exacerbation with a consequent reduction of the associated morbi-mortality. The objective of this clinical study is to determine the evolution of the profile of volatile organic compounds (VOCs) present in the exhaled air (volatolom) in patients with severe COPD after hospitalization for exacerbation. This step should allow the identification of VOCs (modification of the volatolom) which would be associated with a severe COPD exacerbation, by comparing the volatolom at the acute phase of the exacerbation to the volatoloms during the progressive return to a stable state after hospitalization and to those of patients with a stabilized severe COPD (VOC-BPCO clinical study also sponsored by Foch Hospital)
Exacerbations, in particular during chronic Pseudomonas aeruginosa (PA) infection, are very important in the prognosis of patients with non-cystic fibrosis bronchiectasis (BE). In Cystic Fibrosis patients, PA biofilms are associated with chronic respiratory infections and are the primary cause of their increased morbidity and mortality. However, the presence and role in exacerbations of PA biofilms, microbiome dysbiosis and inflammatory biomarkers has not been studied in depth in BE patients. Our aim is to determine the association between PA chronic infection and its biofilms with the number of exacerbations in the next year (primary outcome), time until next exacerbation, quality of life, FEV1 and inflammatory biomarkers (secondary outcomes) in BE patients with or without chronic obstructive pulmonary disease (COPD). The investigators will include and follow up during 12 months post study inclusion, 48 patients with BE and 48 with BE-COPD, with a positive sputum culture of PA. During stability and follow up (and in each exacerbation) The investigators will collect 4 sputum, 4 serum samples, perform spirometry, and quality of life tests every three months. For the biomarkers subproject, 4 additional serum samples will be collected at: exacerbation, 3-5 days after treatment, at 30 days and three months post-exacerbation. Biomarkers will be measured by commercial kits and Luminex. The investigators will quantify PA colony forming units (CFU)/mL, their resistance pattern, their mutation frequency and isolate mucoid and non-mucoid colonies. In each sputum, the investigators will analyze by Confocal Laser Scanning Microscopy (CLSM) and Fluorescent in situ Hybridizatrion (FISH) PA biofilms, their size, bacterial density and their in situ growth rate. Specific serum antibodies against PA will be determined through Crossed Immunoelectrophoresis. In addition, the investigators will indentify potential respiratory microbiome and gene expression patterns predictive for exacerbations, or with a protective role against chronic PA infection, as well as their association with biofilms. Microbiome analysis will be performed through the Illumina Miseq platform. Finally, the investigators will explore the antimicrobial activity of novel combinations of antibiotics against PA, both in in vitro planktonic cultures and in a biofilm model, and will include testing of antibiotic-containing alginate nanoparticles.
Primary Objective: Primary population (former smokers cohort): - 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: Primary population (former smokers cohort): - 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 Secondary population (current smokers cohort) - Estimate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate or severe COPD exacerbations in current smokers with moderate-to-severe COPD - Estimate the efficacy of itepekimab compared with placebo on pulmonary function in current smokers with moderate-to-severe COPD - Estimate the safety and tolerability of itepekimab in current smokers with moderate-to-severe COPD - Estimate the PK profile of itepekimab in current smokers with moderate to severe COPD - Estimate immunogenicity to itepekimab in current smokers with moderate-to-severe COPD
Chronic Obstructive Pulmonary Disease (COPD) is a heterogeneous disease that affects only a fraction of those who smoke tobacco. The origin of this variability in susceptibility to develop COPD is unclear, but understanding its underlying biology has important implications for our ability to design suitable preventative and therapeutic strategies for its management. This Department of Defense (DOD) discovery research proposes to develop methodologies and generate preliminary data needed to lay the foundation for a large study that would investigate the underlying biological susceptibility of those who smoke tobacco to develop COPD.
This project aims to assess the short-term effectiveness and responsiveness of a home-based pulmonary rehabilitation (PR) program (reabilitAR) in patients with chronic obstructive pulmonary disease (COPD). It is also an aim to establish the minimal clinically important differences for PR in patients with COPD for a novel incremental step test (exercise capacity outcome measure). Patients will be recruited at hospitals. Sociodemographic, anthropometric, and comorbidities; vital signs and peripheral oxygen saturation; symptoms (dyspnea, fatigue); lung function; functional capacity; exercise capacity; the impact of the disease, balance, and cognitive function will be collected before the reabilitAR program. Additionally, health care utilization will be registered. Then, patients will be entered into the reabilitAR program (12 weeks). The intervention consists in a strategic mixture of home visits and phone calls. The program includes exercise training and the self-management educational program Living Well with COPD. After 12 weeks all outcome measures will be reassessed. It is expected that the home-based approach will express benefits and reflect the concerns to provide appropriate responses to the patient's needs by increasing access to PR.
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
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.
Social distancing during the COVID-19 pandemic could lead to clinical and functional deterioration of people living with chronic respiratory diseases (CRD). As they are considered risk group for COVID-19, it is not recommended that they leave their house and have interaction with people outside. Thus, most of them have not been attend Pulmonary Rehabilitation sections since the beginning of pandemic, neither exercising outdoor, experiencing drastic restrictions in their activities of daily living. It is well known that low level of physical activity in daily life (PADL) in this population is related to poor prognosis, including higher chance of hospitalization due to exacerbation and mortality. Therefore, the aim of this study is to evaluate the short- and mid-term impact of the COVID-19 pandemic on the clinical, physical and functional conditions and the PADL level of people living with CRD (chronic obstructive pulmonary disease, asthma and interstitial lung diseases). Participants will be assessed during the social isolation period and they will be reassessed immediately after release from social isolation. Thus, the subjects will be followed-up during 12 months to record symptoms, functional status, quality of life, exacerbations and hospitalizations. The researchers' hypothesis is that those patients will present very low level of PADL in association to sedentarism, poor functional status, more symptoms of dyspnoea, anxiety and depression, poor sleep quality and, consequently, will present more episodes of acute exacerbation of the disease and more hospital admission during the study protocol.
Patients with COPD frequently have muscle disorders. Pathogenic mechanisms generate significant pathophysiological changes in the locomotor muscles structure, leading to decreased strength, decreased endurance and limited exercise capacity. Pulmonary rehabilitation is the first choice therapy and training overall lower limb endurance is a priority. Even if the effects of pulmonary rehabilitation are no longer to be demonstrated, it is still necessary to optimize the modalities of muscular strengthening. In fact, it is recommended to associate to this global endurance training a specific strengthening of the muscles of the lower limbs. Neuromuscular electrostimulation (NMES) is a muscular strengthening technique, but this method is not used in usual practice in pulmonary rehabilitation and often only the quadriceps are concerned. In a pulmonary rehabilitation program, including sessions of NMES of the quadriceps femoris and triceps surae could increase its effectiveness. Recent studies suggest that NMES can improve muscle function, exercise tolerance, dyspnea and quality of life in COPD patients. A pilot study compared the effects of the combined quadriceps femoris and triceps surae versus quadriceps alone. The final evaluation showed a greater improvement in exercise capacity in favour of the combined NMES group. Only two studies with small numbers of patients evaluated the effect of combined quadriceps femoris and triceps surae NMES in pulmonary rehabilitation, with encouraging results in terms of functional gain. Further larger studies seem necessary to evaluate the effects of combined quadriceps femoris and triceps surae NMES in pulmonary rehabilitation. The objective of the study is to show that combined quadriceps femoris and triceps surae NMES during a pulmonary rehabilitation program provides a more significant improvement in exercise capacity compared to a standard pulmonary rehabilitation program.