Mechanistic Study of Anti-inflammatory Effects of Fevipiprant in Patients With Eosinophilic Asthma....
AsthmaAsthma4 moreThis is an exploratory, randomized, subject- and investigator-blinded, placebo-controlled mode-of-action study to demonstrate the anti-inflammatory effects of fevipiprant compared to placebo after 12 weeks of treatment in 48 moderate to severe asthma patients with sputum and blood eosinophilia.
A Pilot Study of XOMA 052 in Familial Cold Autoinflammatory Syndrome / Muckle-Wells Syndrome and...
Muckle Wells SyndromeAutoinflammatory1 moreBackground: Autoinflammatory diseases are illnesses that produce episodes of inflammation such as fever, rash, or joint swelling. Some of these diseases can be treated with medications that block the body's reaction to a protein called IL-1, which may be part of the cause of the inflammation. IL-1 blocking agents are very helpful in treating autoinflammatory diseases and have become the standard of care for treatment for some of these diseases. However, more research is needed on related diseases that may be treated with new and currently used IL-1 blocking agents. XOMA 052 is an experimental drug that is currently being tested as a possible treatment for type 2 diabetes. Initial studies have shown that XOMA 052 neutralizes a specific kind of IL-1, and is also active against certain indicators of inflammation. Researchers are interested in determining whether XOMA 052 can be used to treat autoinflammatory and related diseases. Objectives: - To determine the effectiveness of XOMA 052 as a treatment for inflammation in adults with the autoinflammatory diseases Familial Cold Autoinflammatory Syndrome (FCAS)/Muckle-Wells Syndrome (MWS) and Behcet's Disease. Eligibility: FCAS/ MWS: Individuals at least 18 years of age who have a known history of the typical disease. Behcet's Disease: Individuals at least 18 years of age who have evidence of active disease, such as oral or genital ulcers or eye disease. Design: FCAS/MWS Participants Participants will have an overnight evaluation of their disease, including optional tests (e.g., eye or skin exams). Participants who currently take medications to treat their symptoms will stop taking the medication and will be monitored by study researchers. At the first flare of symptoms, participants will begin to receive XOMA 052. Participants will have further tests on days 3, 7, and 10 after the initial dose of XOMA 052. If the disease remains under good control, participants will have a clinical exam every 5 days for up to 10 weeks until another disease flare occurs (determined either by symptoms or by inflammation observed in laboratory studies). If the disease is not well controlled with the initial dose of XOMA 052, participants will have additional doses starting at day 7 until either the disease is controlled or researchers determine that the medication is not effective. Participants will have the option to continue XOMA 052 treatments for up to 1 year. XOMA 052 wil...
Comparison Between Corticosteroid and Topical Steroids in the DRESS
Drug Rash With Eosinophilia and Systemic SymptomsDrug reaction with eosinophilia and systemic symptoms (DRESS) is a rare and severe multiorgan adverse drug reaction occurring within 2 to 6-8 weeks after a new drug intake. DRESS syndrome is defined by the combination of clinical manifestations, cutaneous, visceral and biological disturbances. Its prognosis is directly linked to severity of visceral involvement, with a mortality evaluated above 10%. Considering curative treatment, there is no consensus. Until now, no controlled trial has been performed. Systemic steroids are mainly used in first intention, in particular for management of visceral involvements, whatever their severity. From clinical practice, topical steroids are often used and could be helpful in the therapeutic management of DRESS. We propose to evaluate systemic steroids versus very potent topical steroids in a multicentric randomized controlled trial including defined moderate DRESS, ie the non-inferiority of very potent topical steroids in terms of remission of visceral involvement at Day30 and the superiority of very potent topical steroids in terms of delay to remission of skin involvement.
Clinical Characteristics and Treatment of Chest Tightness Variant Asthma
AsthmaChest Syndrome8 moreAsthma, abbreviation for bronchial asthma, is one of the common chronic airways disease that threatens human health. Typical symptoms of asthma are recurrent wheezing, shortness of breath, chest tightness and cough, usually occurring at night or early morning. However, there are still some patients with only persistent clinical manifestations of chest tightness. Concerned about this group of patients, investigators presented a subgroup of bronchial asthma, namely, chest tightness variant asthma (CTVA). This asthma subgroup usually lacks asthma-specific clinical features such as wheezing, shortness of breath, wheezing, and therefore often misdiagnosed for a long time. However, there is lack of definite treatment strategy for CTVA. In order to further understand the clinical characteristics and treatment of patients with CTVA, investigators conducted a national multicenter randomized control trial(RCT) study that compares inhaled corticosteroid(ICS)/ long-acting beta2-agonist(LABA) + Montelukast with ICS/LABA. Finally, investigators plan to clarify whether ICS/LABA plus Montelukast is more appropriate treatment than only ICS/LABA in CTVA patients.
Prevalence of Chronic Obstructive Pulmonary Disease (COPD) and Eosinophilia Among Primary Care Patients...
Pulmonary DiseaseChronic ObstructiveEarly diagnosis and appropriate treatment for COPD subjects are both critical to minimize the progression of COPD and improve outcomes. Also, evidence suggests that high eosinophil (specific type of white blood cell that protects body against certain kinds of germs) level is associated with increased risk of both moderate and severe exacerbations in COPD subjects. To date, there is insufficient amount of data that describes the prevalence of COPD in Brazilian primary care units. Thus, this multicenter, cross-sectional study conducted in five centers located in five different Brazilian cities will provide estimation about the prevalence of COPD in primary care and will also determine the levels of eosinophils in subjects with confirmed COPD diagnosis. Approximately 2,500 eligible subjects are expected to be enrolled in the study.
Eosinophilia Diagnosis
Hypereosinophilic SyndromeEosinophilia, defined by a blood eosinophil granulocytes rate greater than 500 / mm3, is frequently encountered in internal medicine. Its causes are varied: atopy, drug allergies, parasitic infections, autoimmune diseases and solid neoplasias. Over 200 etiologies have been reported, some difficult to diagnose and can be life-threatening Eosinophilia can be a diagnostic dilemma, as the etiologies are extensive and varied. The aim of this study is to assess the feasibility of a diagnostic approach based on a decision algorithm in a group of patients with eosinophilia. We assume that a procedure with a hierarchy of additional tests would increase the frequency of diagnosed cases while decreasing the time to diagnosis. This procedure defined by an algorithm would even reduce the number of tests necessary to reach a diagnosis.
Characteristics of Eosinophilic Gastritis, Enteritis, and Colitis in a Multi-Site Cohort
Eosinophilic EsophagitisEosinophilic Gastritis2 moreThe purpose of this study is to investigate features of patients with Eosinophilic Gastrointestinal Disorders (EGIDs) other than Eosinophilic Esophagitis (EoE) alone, including Eosinophilic Gastritis (EG), Eosinophilic Gastroenteritis (EGE), and Eosinophilic Colitis (EC).
Functional Dyspepsia (FD) - Clinical Response to Montelukast in Children
EosinophiliaDyspepsiaDuodenal eosinophilia has been associated with dyspepsia in adults and the investigators have previously described the finding of duodenal mucosal eosinophilia in 71-79% of children undergoing diagnostic endoscopy. Previous studies in children have shown positive response to montelukast with approximately 50% finding complete relief and 20-30 percent showing no response. There are a number of factors that have the potential to contribute to the observed variability in response to montelukast. These include variability in: systemic drug exposure (drug absorption, biotransformation and/or elimination) regulation of leukotriene biosynthesis cysteinyl leukotriene receptors and downstream mediators patient disease phenotype (e.g. Functional Gastrointestinal Disorder (FGID) disease classification, psychologic profile) In this study, the investigators propose to utilize biopsy specimens stratified by drug response to identify candidate gene expression modules that will be validated in a prospective study design. The overall goal of this program is to develop a signature of montelukast response that can be applied not only to eosinophilic gastroenteritis, but more generally to other diseases, such as asthma, where the drug is widely used with variable success.
Registry for Eosinophilic Gastrointestinal Disorders (REGID)
Eosinophilic Gastrointestinal Disorders (EGID)Eosinophilic Esophagitis1 moreDevelop Registry tool
L-5-HTP-Related EMS
Eosinophilia-Myalgia SyndromeIn 1989 more than 1500 people who took the dietary supplement L-tryptophan for insomnia and depression developed eosinophilia myalgia syndrome (EMS)-a potentially fatal disease characterized by an excess of a type of white blood cell called eosinophils. Disease symptoms include fever, muscle aches and inflammation, and skin rashes. As many as 40 of the patients who became ill died. It is suspected that impurities in the supplements caused the disease. More recently, similar impurities have been detected in batches of a similar dietary supplement called L-5-hydroxytryptophan. This study is designed to learn more about EMS that develops in patients taking L-5-hydroxytryptophan. The study is open to patients newly diagnosed with eosinophilia myalgia who have taken L-5-HTP. Patients in the study will have a physical examination and urine and blood tests. They may also have X rays, an electrocardiogram, magnetic resonance imaging (MRI), and a skin test for tuberculosis. They will have a psychiatric interview, take a memory test, and fill out questionnaires relating to sadness and depression. Patients may also undergo special tests to study conduction of nerve impulses and muscle function. Samples of patients' supplements will be taken for chemical analysis.