View clinical trials related to Severe Eosinophilic Asthma.
Filter by:This is a prospective, multi-center, single-arm Phase 3b study designed to evaluate the potential benefit to patients if benralizumab treatment could enable reduction in asthma maintenance controllers while allowing patients to maintain asthma control in Chinese patients.
Asthma is a chronic inflammatory disease of the airways that follows a strong circadian rhythm: Signs of inflammation and symptoms worsen especially in the early morning hours. The molecular circadian clock, which is a complex machinery of transcriptional and translational feedback loops, seems to reflect the inflammatory environment of peripheral blood leukocytes. Therefore, in this observational study the investigators will monitor the molecular circadian clock in patients with severe eosinophilic asthma before and during mepolizumab treatment. Our major goal is to evaluate the potential of the molecular circadian clock to serve as a prognostic marker for disease progression, treatment response or remission in patients with severe eosinophilic asthma. The molecular circadian clock will be monitored in blood and sputum leukocytes from patients with severe eosinophilic asthma before mepolizumab treatment, after 4 month of mepolizumab therapy, and once they reach remission under mepolizumab treatment. Effects will be compared to healthy controls and patients with mild-moderate asthma without mepolizumab treatment.
The goal of this observational study is to learn about clinical and functional outcomes in patients with Chronic rhinosinusitis with nasal polyps and comorbid Severe Eosinophilic Asthma and patients with Chronic rhinosinusitis with nasal polyps only treated with mepolizumab compared to healthy controls. Participants will be asked to give nasal, blood and sputum samples before mepolizumab administration (T0) and at 3 (T3), 6 (T6) and 12 (T12) months after mepolizumab initiation The main aims are to identify airways microbiota modifications and differential gene expression after mepolizumab initiation. Researchers will compare: - Patients with Chronic rhinosinusitis with nasal polyps and comorbid Severe Eosinophilic Asthma - Patients with Chronic rhinosinusitis with nasal polyps only - Healthy subjects The research will address the following questions: 1. What are the prospective clinical and functional outcomes of mepolizumab treatment 2. What is the impact of mepolizumab therapy on the airways microbiota and how this may relate to a potentially reduced need for steroids 3. What are the host differential gene expression patterns and the immune/inflammatory (cytokines/chemokines) profile alterations in airways microenvironment and in systemic circulation in response to therapy 4. What are the associations between host and microbiome variables for building up diagnostic and predictive biomarker classifiers of responsive disease endotypes
Severe eosinophilic asthma (SEA) is associated with poor disease control and compromised health-related quality of life (HRQoL), leading to a substantial psychosocial and economic disease burden. Benralizumab (Fasenra®), an interleukin (IL)-5-alpha receptor monoclonal antibody, is approved as an add-on maintenance treatment for SEA. This study aims at collecting real-world data that extend beyond the clinical effectiveness of benralizumab to the participant-reported impact of treatment on their HRQoL, sleep quality, depression, anxiety, work productivity and activity impairment, but also on treatment effectiveness. Recent technological advances in portable spirometers and wearable activity trackers (WAT) to increase physical activity for participants with asthma, even for older participants, allow this study to collect data on lung function parameters and physical activity from such devices for the first time at a country level in Greece. Using a multi-aspect approach, this study will generate real-world evidence on a broad range of both well-established clinical and novel patient-centered outcomes which are critical to the assessment of the therapeutic benefit both from the physician's and the participant's perspective. All main study outcomes will be examined at various timepoints throughout the course of the 48-week observation period, starting as early as 4 weeks after treatment initiation, thus enabling the identification of 'early' treatment responders with a closer focus on patients' physical and psychological well-being and HRQoL in addition to asthma control and lung function metrics
Benralizumab is a humanised, afucosylated, monoclonal antibody against the interleukin (IL)-5 receptor (IL-5R) α subunit that induces direct, rapid, and near-complete depletion of eosinophils in blood, airway tissue, and bone marrow through enhanced antibody-dependent cell-mediated cytotoxicity (ADCC). This apoptotic process involves natural killer cells responsible for the controlled eosinophilic elimination. In the two pivotal phase III trials SIROCCO and CALIMA, benralizumab was well tolerated, significantly reduced asthma exacerbations by up to 51%, and improved lung function as well as disease control in patients with severe, uncontrolled asthma and blood eosinophil count of ≥ 300 cells/μL blood, receiving both ICS and LABA. According to the summary of product's characteristics (SmPC) of benralizumab in Russia, it can be used for an add-on maintenance treatment for adult patients with severe eosinophilic asthma. All patients enrolled in the BEST study will comply with the SmPC approved by the Russian Ministry of Health.
The purpose of this observational study is to describe the population of patients with SEA + NP who have been prescribed FASENRA and assess available clinical outcomes for both NP and asthma.
This is a real-life pragmatic non-randomised study to explore the impact of mepolizumab on the emotional and affective outcomes of patients with severe eosinophilic asthma and their partners. It will be conducted in two quantitative stages (Phases 1 and 2) with an additional third qualitative component (Phase 3).
Chronic airway inflammation rich in eosinophils is an important feature seen in asthma. Airway and blood eosinophilia is associated with increased rates of asthma exacerbations and more intense treatment. Recently, the existence of two distinct eosinophils subtypes was revealed-lung-resident eosinophils (rEOS), which maturate independently to interleukin (IL) 5, with the primary function to maintain tissue homeostasis, and inflammatory eosinophils (iEOS), which mature in IL-5-dependent manner and are mainly involved in immune responses. Eosinophils' effect on the airway remodeling in asthma depends not only on the activity but also by their viable number in the lungs. Blood iEOS infiltrate the airways mainly after the environmental stimulus like allergen and leave the airways with bronchial secretions. However, rEOS reside lung tissue for their entire lifetime regulating local immunity. Blood rEOS and iEOS ratio alters in asthma, compared with healthy controls. It is known that the predominant eosinophils subtype in allergic asthma are iEOS, while rEOS are basic subtype in severe eosinophilic asthma patients, moreover, they are different in adhesive properties and survivability as well. Distinct biological properties allows to speculate about their different functions in asthma, however, there are still little information. Data about differently expressed microRNA (miRNA) profiles in eosinophils in asthma suggests, that eosinophils subtypes can be distinct in non-coding RNA (ncRNA) - microRNA (miRNA), piwi-interacting RNA (piRNA) and long non-coding RNA (IncRNA) profiles that could describe their role in asthma pathogenesis and act as biomarkers to discern asthma phenotypes.
This is a multicentre, randomised, open-label, parallel-group, active-controlled, phase IV study to assess the reduction of daily Symbicort® maintenance to anti-inflammatory reliever treatment only in participants with severe eosinophilic asthma on Fasenra® treatment, while maintaining asthma control.
Observational, retrospective study in adults (≥18 years) with severe asthma (maintenance treatment with high dose inhaled corticosteroids combined with long-acting agonist β2) and eosinophilic phenotype, who at the discretion of the investigator were candidates to receive benralizumab in the individualized access program approved by national health authorities. Primary Objective: To describe the demographic and baseline characteristics in patients with severe eosinophilic asthma who participated in the individualized access program approved in Spain and received at least one dose of benralizumab. Secondary Objectives: To describe clinical outcomes in severe eosinophilic asthma patients who received at least three doses of benralizumab in the individualized access program.