View clinical trials related to Severe Asthma.
Filter by:Eosinophil infiltration and degranulation in airways has been implicated in the pathology of asthma. Periostin is considered to be a marker of eosinophilic inflammation and is one of the highly expressed genes in epithelial cells and lung fibroblasts in asthma. Omalizumab is approved as add-on therapy in the treatment of severe allergic asthma. The aim of the study is to assess inflammatory biomarkers including: blood and sputum eosinophilia, periostin and IL-6 as long-term clinical outcomes of omalizumab therapy.
Approximately, 5% of the patients with asthma suffer a difficult-to-control severe variant of the disease. Despite being treated with inhaled corticosteroids (ICs), long-acting β2-agonists (LABA), oral corticosteroids or omalizumab, one or more components of the control concept (symptoms, exacerbations, bronchial obstruction) remain to be resolved. Omalizumab has been proven to safely reduce asthma exacerbations and to decease symptoms and quality of life in severe allergic asthmatics. However, approximately 25% of the treated patients fail to respond to this monoclonal antibody. The rest of them show different degrees of response, although the rate of asthmatics who achieve control of the disease is unknown because clinical trials of omalizumab have been carried out to assess the impact of the drug on exacerbations, symptoms or even pulmonary function, but its effect on control was not evaluated. Therefore, there is a need to find new therapeutic options for those severe asthmatics who remain uncontrolled despite having received all the recommended therapies (including omalizumab). Reslizumab is a humanized anti-interleukin-5 (IL-5) monoclonal antibody (mAb) that has been recently found to reduce exacerbations and to improve pulmonary function and symptoms in patients with severe asthma and high peripheral eosinophil counts. It would be important to demonstrate that Reslizumab is able to improve the clinical condition of severe asthma patients with no therapeutic options.
This study is a prospective observational multicentre cohort study of asthma patients in Eastern Africa whose objectives will be; The primary objective of this project is to identify and characterize severe asthma in Eastern Africa in order to understand its demographic, clinical, physiologic, pathologic, genomic and immunologic determinants. Secondary objective(s) are; Compare the annual healthcare utilisation (HCU) (emergency room visits, hospitalization including admission to critical care units and unscheduled outpatient clinic or office visits), exacerbation, quality of life and mortality rates of severe and not- severe asthma patients Determine the factors associated with the asthma HCU events, quality of life, exacerbations and mortality The study will enroll 1676 patients aged between 12 and 70 years and follow up each patient for up to one year.
This study evaluates the longterm clinical outcomes, including safety and efficacy parameters after Bronchial Thermoplasty (BT) treatment over a period of 5 years. All patients included in de TASMA trial in the Netherlands will be asked to participate in the TASMA extension study.
This purpose of this clinical trial is to determine if a statin drug, Simvastatin, added to inhaled corticosteroids and bronchodilators can reduce systemic and airway inflammation, improve lung function and symptoms, and reduce acute exacerbations in patients with severe asthma who are already on controller inhaler therapy. This proposed investigator-initiated, single-center, early Phase II, cross-over, randomized clinical trial, titled "Randomized Trial of Simvastatin for the Treatment of Severe Asthma", will be conducted at the University of California, Davis Medical Center (UCDMC) in Sacramento, CA. This trial will evaluate Simvastatin for treatment of asthma in subjects with severe asthma (as defined by the American Thoracic Society (ATS)), who are already taking inhaler controller therapy. The investigators plan to enroll 24 patients with severe allergic asthma. The investigators hypothesize that treatment with Simvastatin 40 mg (administered once daily) will not only improve indicators of airway and systemic allergic/Th2 inflammation, but will also reduce acute exacerbations and improve lung function. All patients will be on standard controller therapy including appropriate doses of inhaled corticosteroids and long-acting bronchodilators.
The purpose of this prospective study is: - to identify by cluster analysis the main phenotypes of severe asthma and factors involved in the severity, - to determine the clinical and functional outcomes, - to identify the factors associated with severe asthma from childhood to adulthood.
Asthma is the most common chronic respiratory disorder in children. Despite significant advances in understanding of asthma, available therapies fail to alter the natural history and progression of the disease. Airway epithelial cells are continuously exposed to and injured by environmental irritants, such as viruses and pollutants, and as such are ideally situated to orchestrate airway function in response to these stimuli. Severe or difficult-to-treat asthma in children is a complicated disorder characterized by ongoing symptoms and persistent airway inflammation and oxidant stress despite corticosteroid treatment. Although severe asthma is likely a heterogeneous disorder, affected children similar clinical features, including gas trapping, bronchial hyperresponsiveness, and aeroallergen sensitization. However, the molecular and cellular pattern of inflammation in children with severe asthma are not uniform : some investigators have found increased eosinophils and TH2 derived cytokines, others have noted noneosinophilic patterns with neutrophil activation. Given the heterogeneity of the inflammatory response in children with severe asthma, additional methods to distinguish severe asthma are needed.
SEVERE ASTHMA IN THE COMMUNITY- BACKGROUND Severe asthma is a common problem. In the world approximately 300 million people have asthma but it is estimated that only 5% of these patients have severe asthma. Although "severe asthma" comprises a small fraction of the entire asthmatic population its share in the total economic burden of asthma is 80 percent. In Israel the prevalence of asthma among adult patients is about 5-6% but the prevalence of severe asthma is unknown. The definition of severe asthma has been changed during the years. Most recently in 2009 the WHO agreed on a unified definition of "severe asthma" that would fit countries of different socioeconomic development [1]. Severe asthma includes now 3 different groups: group one "untreated severe asthma", group two "difficult to treat severe asthma" and group three "treatment-resistant severe asthma". As all asthmatic patients in Israel have easy access to medical care, the current study will deal with the last two groups ("difficult to treat asthma" and "treatment resistant asthma"). AIMS Primary endpoints: 1. To identify the prevalence of severe asthma in the community according to the WHO definition of group two & three. 2. To assess whether anti-IgE therapy (Omalizumab), was considered in these groups of severe asthma. Secondary endpoints: 1. To assess factors involved in "difficult to treat asthma" according to the WHO definition. Factors as patient compliance, presence of co-morbidities, symptoms of untreated potential asthma triggers including GE reflux, post nasal drip/atopic rhino-sinusitis, and intervening medications including NSAID and beta-blockers. 2. To asses the level of asthma control, level of patient follow-up care including asthma specialist visits, periodic PFT's and asthma education. 3. To assess the fraction of patients with severe asthma that is eligible to anti-IgE therapy according to the indications of the Israeli Ministry of Health (proven asthma, uncontrolled by high dose of combined ICS+LABA inhaler therapy + at least 2 courses of systemic corticosteroids in the last year + proven atopy to at least one perennial aeroallergen + IgE level of 30-1,500 IU/ml) DESIGN A prospective non-blinded non-randomized observation study among the population insured by Clalit Medical Services (CMS) in the Sharon- Shomron Medical District in Israel.
As Conditions of Approval of the PMA for the Alair System, the FDA requires Boston Scientific to generate data to assess the durability of the BT treatment effect as well as safety data in the intended use population in the United States.
The purpose is to determine if: 1) Escitalopram treatment will be associated with less oral corticosteroid use than placebo in outpatients with severe asthma and moderate or severe major depressive disorder (MDD). 2) Escitalopram treatment will be associated with greater improvement in asthma symptoms than placebo in outpatients with severe asthma and moderate or severe MDD. 3) Escitalopram treatment will be associated with greater depressive symptom remission rates than placebo in outpatients with severe asthma and moderate or severe MDD.