View clinical trials related to Uncontrolled Asthma.
Filter by: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.
Asthma is characterized by changes in eicosanoids metabolism, especially high production of bronchoconstrictive cysteinyl leukotrienes (CystLTBs) and leukotriene B4 (LTB4). Recent studies have also demonstrated a relative low production of lipoxin A4, an endogenous lipid mediator resulting from lipo-oxygenase action, distinct from CystLTBs, with anti-inflammatory properties, in bronchial epithelial cells and lung macrophages of severe asthma patients, leading to imbalance between pro-resolving and pro-inflammatory eicosanoids production in airways. Such data suggest that aspirin, that induces lipoxins production, could restore lipoxins deficit in severe asthma. Interest for aspirin is also supported by data obtained in asthma patients with aspirin intolerance (Aspirin induced asthma, AIA) : in this particular group of patients, aspirin treatment significantly improves nasal symptoms, quality of life, asthma and rhinitis scores, and reduces need for hospitalizations, nasal surgery and oral steroids use. Potential effect of aspirin in patients with uncontrolled asthma without aspirin intolerance, who presented changes in arachidonic acid pathway close to those observed in AIA, is not established. The aim of the study is to assess whether long term aspirin treatment could improve asthma control, compared to placebo, in patients with uncontrolled disease and nasal polyposis, whatever their aspirin tolerance level.
Asthma is one of the most common chronic health conditions, affecting 900,000 Ontarians, 2.4 million Canadians and over 300 million people worldwide. Unlike most other chronic diseases, asthma affects a significant proportion of children - an estimated 21% in Ontario. Asthma is also the leading cause of hospitalization for children in Canada and is a significant cause of school and work absenteeism. Though asthma is generally considered a chronic disease, it can be fatal in some instances - in 2009, an estimated 91 Ontarians died of this condition. Effective management of asthma can prevent exacerbation and more severe negative health consequences. In fact, estimates show that over 80% of the asthma-related deaths could be prevented through proper education. However, evidence also shows that over 55% of patients with moderate to severe asthma do not have their asthma symptoms under control, despite regular doctor visits. Less than a third (31%) of asthma patients report receiving an asthma action plan from their physicians, although such plans are associated with fewer ER visits, lower hospitalization rates and improved lung function. Hence, there is a clear opportunity to improve the management of asthma and reduce the incidence of related complications. Given the scientific evidence of pharmacists effect on asthma management there is a strong rationale for introducing an asthma-specific pharmacist-led intervention for Ontarians suffering from this chronic disease. However, the implementation of such a program should be preceded by a pilot test to ensure that the program parameters are optimized to drive improved patient outcomes and maximum quality of service. The primary goals of this research project are to examine the impact of a pharmacist led asthma management intervention on patient health outcomes and to determine the optimum program structure to ensure quality of service delivery. This study employs a mixed-methods study design. Investigators will begin with a cluster randomized controlled trial and end with exit interviews.This study will consist of a prospective, randomized controlled trial conducted in the community setting. A total of 12 pharmacies across the Greater Toronto Region will be recruited for this study. Each of these pharmacies will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. All data will be analyzed using statistical software. Significance level will be set at 0.05. Pharmacy level descriptive characteristics, including mean and standard deviation for the number of patients will be reported. There is a low perceived risk for this study; however, the investigators will take every precaution to ensure this study is conducted in an ethical manner, including protecting patient confidentiality and anonymity.
A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist
A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist