View clinical trials related to Asthma.
Filter by:SHR-1703 is a monoclonal antibody under development for severe asthma. This study is the first study in patients with asthma. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics ，pharmacodynamics and immunogenic characteristics of multiple subcutaneous injections of SHR-1703 in asthmatic patients.
While the bidirectional relationship between the lung and the right heart are well studied, the cardiopulmonary interactions between the lung and the left heart are largely unresearched and not well understood. However, in recent years, there is a growing evidence that partially explains the bidirectional interaction between COPD and left heart. Systemic inflammation with multiorgan involvement is thought to play a role in COPD as a systemic disease. Some therapeutic approaches to COPD also appear to influence these cardiopulmonary interactions. While understanding these interactions is very important for clinicians, scientific data are scarce. Cardiac magnetic resonance imaging (cardiac MRI) is the gold standard for assessing cardiac function and dimensions as well as myocardial inflammation. Despite this excellent suitability of cardiac MRI for the assessment of cardiovascular function, only few studies have investigated cardiac function and myocardial structure in patients with pulmonary disease using cardiac MRI. Such a study is therefore very important for understanding the effects of pulmonary disease and its management on the heart. The objective is to determine cardiac function in patients with pulmonary disease and to analyze the cardiovascular effects of the treatment of the pulmonary disease. Specifically, the following will be studied: - Using cardiac MRI: Cardiac function and volumes and indications of myocardial fibrosis and edema in patients with chronic pulmonary disease at the time of first diagnosis. - the vascular function of pulmonary arteries in these patients, also using cardiac MRI - the relationship between pulmonary function parameters and cardiac dysfunction to identify patients at increased risk, if applicable. - Echocardiographic assessment of left heart including strain analysis. - the course of these cardiovascular parameters (using cardiac MRI and echocardiography) 3-6 months after initiation of guideline-based therapy for pulmonary disease.
This study pretends to evaluate the potential use of Hyfe Cough Tracker (Hyfe) to screen for, diagnose, and support the clinical management of patients with respiratory diseases, while enriching a dataset of disease-specific annotated coughs, for further refinement of similar systems.
Rationale Although the majority of asthma patients can be effectively treated with currently available medications, a substantial subset remains severe, causing a considerable proportion of resource expenditure. Severe asthma is now widely accepted to be a heterogeneous syndrome consisting of multiple phenotypes identified by specific biomarkers and targeted by tailored biological therapies. However, much remains unclear regarding the best approaches to manage these patients, or concerning the pathophysiological mechanisms underlying the disease. Small airways (SA) are defined as those airways with an internal diameter <2 mm. In patients affected by asthma, it has been reported that SA are the predominant site of airflow resistance. Peripheral airways are thickened in asthma due to chronic inflammation in the epithelium, submucosa and muscle area. It has been suggested that the outer wall is more inflamed than the inner wall, with a higher number of lymphocytes, eosinophils, and neutrophils associated to an increased mRNA expression of interleukin-4 (IL-4), IL-5 and eotaxin. Moreover, it is well documented that SA inflammation and dysfunction contributes significantly to the clinical impact of asthma and that 50-60% of asthmatics have a SA involvement across all disease severities. An important question is whether SA disease in asthma is variable among distinct asthma phenotypes and whether it occurs in all patients. Cluster analyses have been recently used to identify specific asthma phenotypes, but markers of SA function have not been investigated. However, evidence is accumulating to support the concept that SA dysfunction and inflammation may contribute to distinct asthma phenotypes. Recent findings indicate that SA are significantly affected in severe asthma and that their involvement is associated with worse disease outcomes. It has been reported that patients with asthma and a history of frequent exacerbations per year had a significant SA involvement Furthermore, peripheral airways significantly contribute not only to the level of asthma control, but also to patients' quality of life and perception of symptoms. At last more thickened SA and higher numbers of eosinophils are detectable in subjects with fatal asthma. The assessment of SA represents a big challenge and requires qualified expertise and sophisticated techniques including body plethysmography, single and multiple breath nitrogen washout, impulse oscillometry (IOS), fraction exhaled NO at multiflow, sputum induction and high-resolution chest CT (HRCT). Such procedures can either provide functional information on the degree/extent of ventilation heterogeneity and air trapping or facilitate the understanding of the inflammatory and remodeling processes. These measures are not usually part of the evaluation of asthmatic patients and in the monitoring of the effects of drugs recommended for severe asthma. Mepolizumab represents an innovative weapon for the treatment of severe eosinophilic asthma. In most of these patients the drug controls inflammation, improves lung function, ameliorates clinical symptoms, reduces exacerbations and has a marked steroid-sparing effect. However, there is still a significant proportion of non-responders and a lack of validated predictive biomarkers in such subpopulation. In regard to this, very limited findings are available about the effect of mepolizumab on SA. At the best of our knowledge, the only paper available in literature, addressing the topic, is the study of Farah and co-workers. The authors found that an early improvement in SA function was associated with better asthma control and represented a significant contributor to the therapeutic response. However, the study was conducted in a limited cohort of patients, assessing SA only through multi breath nitrogen washout, and not considering the relationship between SA disease and levels of peripheral/sputum eosinophils. Also, a study was recently initiated at the Hopitaux de Paris to evaluate airway remodelling during mepolizumab treatment (REMOMEPO, NCT03797404). A better definition of severe asthma phenotypes and endotypes, as well as the identification of novel disease targets and biomarkers to predict treatment response and monitor efficacy and safety of biological drugs over time, would favor a Precision Medicine approach translating in both improved disease management and reduced healthcare costs and social burdens. This is considered a crucial unmet need and further research in the field is strongly recommended by international guidelines, respiratory scientific societies, healthcare systems and regulatory boards.
Workers in the salmon industry are at risk of developing allergies and respiratory diseases, including asthma, due to occupational exposure to bioaerosols, i.e. biological agents such as allergens, enzymes and endotoxins, in their work environment. The overall objective of this intervention trial is to identify effective and feasible control measures (interventions) that reduce exposure to these bioaerosols. The project comprises nine salmon processing factories in northern, central and western Norway. The factories are allocated to either one of the two intervention arms or the control group. In all factories, an assessment of exposure to bioaerosols will be performed. In addition, employees will be invited to undergo a health examination and fill out a self-administered questionnaire including information on demographics, work tasks, health and health promoting factors. The intervention trial is part of a broader study that comprises several substudies including the identification of clinically relevant allergens, investigation of exposure-response relationship between the exposure to individual bioactive agents in bioaerosols and investigations of prevalence of airway symptoms, altered lung function, skin symptoms or immunological responses indicating hypersensitivity. Finally the project includes the identification of health promoting factors that are present in the salmon processing industry. The project is an interdisciplinary multi-center study that places great emphasis on a close dialogue between the researchers and industry in all phases of the project.
The overall goal of this study is to understand biological responses related to dupilumab treatment among severe asthma patients. Not all asthma is the same, and characteristics of asthma vary from person to person. The study will investigate whether the study drug can help to improve the health of participants lungs, boost immune response, as well as improve quality of life.
This study is a two strata, dose escalation Phase I clinical trial designed to assess the safety and determine the maximal tolerated dose (MTD) of allogenic cord tissue derived MSCs (cMSCs, stratum 1) and allogeneic, interferon-γ primed bone marrow MSCs (γMSCs, stratum 2). Each stratum is designed to independently accrue 3 children at a dose level 1 of 2x106 cells/kg and 6 children at dose level 2 of 10x106 cells/kg, resulting in 9 children in each stratum. The primary objectives are to determine the safety and toxicity of allogeneic cord tissue derived MSCs and allogeneic interferon-γ primed bone marrow derived MSCs.
Most of clinical cohorts focused on the course of asthma over time and on the different phenotypes of asthma have investigated children and adults separately. The passage from childhood to adulthood is scarcely explored. In this context, we decided to explore the course of asthma severity from teenage to adulthood in children with severe asthma. The secondary objectives are to assess the quality of life and socioeconomic status in adulthood. This study will be both retrospective (data collected during childhood) and prospective (data collected during adulthood), multicentric and observational
The purpose of this double-blind, randomized, controlled clinical trial is to investigate the effect of a three-day azithromycin treatment versus placebo treatment in children aged 1-5 years who are hospitalized due to asthma-like symptoms.
Bioequivalence study between two inhaler products of ffluticasone propionate inhalation powder