Active clinical trials for "Asthma"

Background: Asthma is a heterogeneous respiratory disease and the most common chronic disease in children. A small subset of children has continuous poor asthma control despite appropriate adherence to asthma medication. There is a clinical need to identify these children as early as possible to optimize treatment and/or to find therapeutic alternatives. Therefore, the "Systems Pharmacology approach to uncontrolled Pediatric Asthma" (SysPharmPediA) study was set up. Objective: To establish a cohort of pediatric moderate-to-severe uncontrolled and controlled patients with asthma in order to investigate pathophysiological mechanisms underlying uncontrolled moderate-to-severe asthma in children on maintenance treatment, using a multi-omics systems medicine approach. Methods: In this multicenter observational case-control study, moderate-to-severe asthmatic children (n=145, age 6-17 years), were included in specialized hospitals in four European countries (Netherlands, Germany, Spain and Slovenia). Recruited subjects were selected based on good asthma control (controlled asthmatics, n=54) or poor asthma control / recurrent exacerbations (uncontrolled asthmatics, n=91). Comprehensive details concerning demographics, current and past patient/family history and clinical characteristics were collected. In addition, systems-wide omics layers, including epi(genomics), transcriptomics, microbiome, proteomics and metabolomics will be evaluated from multiple collected, relatively non-invasive, samples of from the recruited individuals, such as: blood, feces, saliva, nasal swabs and exhaled breath. Follow-up visits were performed 6 and 12 months after inclusion.

The objectives of this study are to use the Delphi method to assemble an expert panel representing innovation in asthma treatment, to collect freely suggested recommendation statements concerning OCS tapering (and sub-topics) among severe asthma patients from this panel for peer evaluation, and finally to determine the level of consensus for each statement from the panel as a whole.

Perform an exploratory analysis of association between consumption of high excess free fructose (EFF) beverages (high fructose corn syrup sweetened soft drinks, fruit drinks, apple juice) and Chronic Bronchitis (CB)/history of CB, and asthma/ history of asthma.

The investigators aim to determine the optimal number of measurements required for multiple-breath-washout derived lung function parameters in adults with pulmonary disease as well as in healthy controls

Asthma is often associated with various comorbidities that may influence its clinical expression. Among those, chronic rhinosinusitis with nasal polyposis (CRSwNP) is observed in 5% of cases. Asthmatic patients with CRSwNP appear to have more severe and poorly controlled asthma, as well as greater bronchial and systemic inflammation, especially those using inhaled corticosteroids as control medication. However, this remains to be validated. In the last decade, there has been interest labeled for phenotyping of asthma and CRSwNP. However, there is scarce data on the phenotype of asthma with CRSwNP. This study aims to describe the phenotype of asthmatic patients with CRSwNP according to the clinical, physiological and inflammatory characteristics and whether there is a more severe phenotype related to the dose of inhaled corticosteroids and the percentage of induced sputum eosinophils.

The main hypothesis of this study is to see if children and adolescents with poorly controlled asthma will find the Propeller electronic monitoring device is feasible and acceptable, and will result in improved medication adherence and asthma control. Preliminary studies indicate that Propeller can improve medication adherence rates in children with asthma and reduce the number of days of reliever medication used. It also has been shown to reduce missed days of school and hospitalizations due to asthma exacerbations. The Propeller device is a sensor that fits over inhalers and uses Bluetooth connection to cell phones to remind patients to take their medication. It also records use of the controller and rescue inhalers, allowing for parents, physicians, and patients to get a fuller and more accurate picture of their adherence to treatment and severity of disease. With improved adherence, asthma control should improve, resulting in a decreased costs and use of services.

The pattern of lower airway inflammation in asthma is heterogeneous, but in many patients, the polymorphonuclear neutrophil (PMN) is the predominant granulocyte infiltrating the airspaces. Although it is known to have an important function in innate immune defense, the role of the PMN in asthma has not been well elucidated. In work in progress, the investigators have identified the receptor for IL-5 on the surface of bronchoalveolar lavage (BAL) PMNs in a subset of children with severe, treatment-resistant asthma, a characteristic that is not found in peripheral blood neutrophils. While the function of this IL-5 receptor has yet to be determined, preliminary evidence strongly supports a mechanism linking neutrophilic with type 2 inflammation in the lower airways of children with asthma, a discovery that has exciting potential to modify the treatment of asthma. The primary objective of this observational cross-sectional study is to test the overall hypothesis that therapeutic intervention directed against the IL-5R on lung PMNs will decrease inflammation and improve clinical outcomes in patients with poorly controlled asthma. The secondary study objective is to demonstrate that IL-5R expression on lung-infiltrating PMNs is functional, will activate known IL-5R-induced signaling pathways, and will lead to enhanced PMN pro-inflammatory activity including increased PMN recruitment, prolonged survival, degranulation, and release of reactive oxygen species.

Retrospective secondary data collection observational chart review study. Data collection and analysis will be performed on a cohort of patients who have previously been enrolled on the BPAP. Approximately 300 patients taking part in the BPAP between April 2018 and November 2019 and who meet the eligibility criteria will be recruited to participate in the study. Data for each participant in the study will be obtained retrospectively with a focus on obtaining data at baseline (12 months prior to first benralizumab dose or at first assessment in the severe asthma center if <12 months), Index date (date of first benralizumab dose) and at least up to 24 months after index date. Primary Objectives To describe baseline demographic and clinical characteristics of severe eosinophilic asthma patients enrolled in the BPAP To describe background treatment patterns of severe eosinophilic asthma patients at baseline and after benralizumab initiation Secondary Objectives: To describe clinical outcomes after initiation of benralizumab therapy in severe eosinophilic asthma patients treated with benralizumab at 12 and 24 months To describe patients' adherence to benralizumab, persistence and discontinuation rates and reasons for discontinuation at 12 and 24 months

A retrospective database pre-post cohort study, identifying asthmatic patients, aged 6- 11, with omalizumab use over 24 months

This study is a retrospective cohort study of patients diagnosed with asthma based on the data extracted from the MDV database. The study period is from 1st Jun 2016 to 29th February 2020 .