
Prospective Registry of Eosinophilia With Respiratory Manifestations With Translational Research...
Eosinophilic AsthmaEGPA - Eosinophilic Granulomatosis With Polyangiitis3 moreIntroduction: The etiology and therapy of eosinophilic lung diseases are still poorly understood. For individual forms of disease, such as eosinophilic asthma or eosinophilic granulomatosis with polyangiitis (EGPA), new therapeutic approaches exist that block the interleukin IL-5 or the IL-5 receptor. Eosinophilic manifestations of the respiratory tract can exclusively affect the lungs or occur as part of a systemic disease. The manifestations partially overlap and are clinically difficult to differentiate (e.g. eosinophilic asthma, Samter Triad, EGPA or hypereosinophilic syndrome (HES)). It is now known that blood eosinophil counts correlate with the level of eosinophils recruited to the airways. However, it is still unclear whether there is a blood eosinophilia without clinical relevance or whether there is a risk of organ damage (e.g. in HES). Hence, different subtypes of eosinophils with different polarization are discussed. Aim of the study: A registry of patients with eosinophilia and respiratory manifestation will be established at the University Hospital of Innsbruck. The course of disease will be evaluated prospectively in a non-interventional study. This study stands on three main clinical pillars with focus on further characterization of eosinophilic cells: Patients will be included who switch from a previous application of the anti-IL5 antibody mepolizumab (production and administration of the injection from lyophysate through the doctor) to the pre-mixed pen (self-injection at home). Furthermore, special focus is set on patients suffering from the so-called Samter Triad. In these patients, the control of asthma, nasal polyps and NSAID intolerance will be examined in an interdisciplinary fashion during the course of treatment. Previous clinical studies at our Department indicate that some patients with severe eosinophilic asthma or Samter Triad could represent a mono-organic or limited manifestation of lymphoid HES. This hypothesis is tested by measuring additional chemokines, somatic mutations and FACS parameters in this subgroup to verify a clonal disease. In addition, translational research will differentiate resident and inflammatory eosinophilic granulocytes by FACS analysis and further characterize them by fluorescence microscopy, electron microscopy, gene chip analysis and lipidomics, in the above-mentioned diseases and in healthy controls, respectively. Patients and methods: All patients suffering from eosinophilia with pulmonary involvement who are diagnosed with eosinophilic asthma, EGPA, Samter Triad, HES, and eosinophilic pneumonia with signed consent are included in the prospective registry. Provided, that they are registered at the outpatient department of pneumology, ENT, haematology or allergology at the University Hospital Innsbruck. The investigators will collect laboratory analyses, lung function, imaging, bone marrow biopsies, ENT findings and allergological findings over the course of the study. Furthermore, additional blood tubes are collected during routine blood tests, which are used to identify and characterize subtypes of eosinophilic granulocytes. Risks for patients: No additional examinations, blood sampling or invasive measures are required for the patient. Thus, there is no additional risk for study participants. Risks for control subjects: In order to be able to compare our results with the healthy population, volunteer subjects are recruited. After consent has been given, a blood sample is taken. Despite the low risk, it is theoretically possible that blood sampling may be accompanied by non-severe complications (such as hematoma, infection). Benefits: The investigators expect new insights into phenotype and therapy of patients with eosinophilic manifestations of the respiratory tract.

Natural History of Hypereosinophilia and Hypereosinophilic Syndromes
EosinophiliaHypereosinophilic SyndromeUnexplained chronic hypereosinophilia (HE) and hypereosinophilic syndromes (HES) are heterogeneous regarding the organ involvements (heart, lungs, skin, .. or none), the evolutionary profiles, the response to treatments. Underlying mechanisms are largely unknown and may associate genetic predisposing factors (germinal ? somatic?), environmental factors (alimentation, tobacco use, hormones, infections, ..) The COHESion study aims to study all clinical and biological characteristics of HE/HES patients and their evolutionary profiles, with a focus on genetic factors and the mechanisms supporting transitory or persistant chronic HE/HES (in absence of any well identified extrinsic trigger like drugs, parasitosis, ..)

Study of Gastric Motility in Eosinophilic Gastritis
Eosinophilic GastritisGastroparesis1 morePurpose: The study is a cross-sectional observational study designed to determine if eosinophilic gastritis (EG) results in gastric motility impairment. Hypothesis: Gastric dysfunction occurs in the natural history of EG but is underdiagnosed due, in part, to contraindications to the use of the standard meals used in gastric emptying studies.

Drivers of Eosinophilic COPD Exacerbations
COPD ExacerbationEosinophiliaMain objective: investigate gene expression differences in nasal epithelium and sputum between eosinophilic COPD exacerbations and other subtypes.

OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages
Eosinophilic Gastrointestinal Disorders (EGIDs)Eosinophilic Esophagitis3 moreThe purpose of this observational study is to find the best measures to define how well a person with eosinophilic disorder is doing. People with EoE, EG, EGE and EC normally undergo endoscopy and/or colonoscopy where cells are collected for microscopic analysis. Treatments are then decided based on how the cells look. We are aiming to compare different tissue components such as inflammatory cell types with clinical symptoms. We want to see if scores on standard questionnaires can give us an idea how well the person is doing.

Phase II Gleevec Idiopathic Hypereosinophilic Syndrome
EosinophiliaHypereosinophilic SyndromeThe purpose of the trial is to determine the safety and efficacy of Gleevec" in idiopathic hypereosinophilic syndrome (HES) and to characterize the molecular basis for the therapeutic benefit of Gleevec" in HES.

A Proof-of-mechanism Study of Multiple, Oral Doses of Fevipiprant (QAW039) in COPD Patients With...
Chronic Obstructive Pulmonary DiseaseThis was an exploratory, randomized, subject- and investigator-blind, placebo-controlled, parallel group, proof-of-mechanism study of multiple oral doses of fevipiprant (QAW039) in chronic obstructive pulmonary disease (COPD) patients with eosinophilia.

Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis
Eosinophilic GastroenteritisThe purpose of this study is to investigate the effect of an elemental diet on adult patients with Eosinophilic Gastroenteritis

An Extension Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis...
Eosinophilic GastritisEosinophilic Gastroenteritis1 moreThis is a Phase 2, open-label, extension study to assess the safety and tolerability of AK002, given monthly for up to 26 doses.

Steroid Treatment for Hypereosinophilic Syndrome
EosinophiliaHypereosinophilic Syndrome2 moreBackground: - Hypereosinophilic syndrome (HES) is a disorder in which the body has too many eosinophils (a type of white blood cell). Too many eosinophils in HES can cause damage to the heart, nerves, or skin. Certain drugs can help lower eosinophil counts to prevent tissue damage. Corticosteroids, such as prednisone, are used for initial therapy in this disorder. Although most people respond to prednisone, some people develop side effects from it, or do not respond very well to treatment. Better ways of determining the dose to give could help to decide on the best therapy for HES. Objectives: To determine whether a single-dose of prednisone can be used to predict which people with hypereosinophilia respond to treatment. To study lack of response to steroid treatment in people with HES. Eligibility: Inclusion criteria: Individuals with hypereosinophilic syndrome with high eosinophil counts. Individuals who are willing to have blood drawn before and after getting steroids. Exclusion criteria: Individuals who are on more than 10mg of prednisone (or similar drug) Individuals with hypereosinophilic syndrome who are on other medications that could interfere with the study Women who are pregnant or breast-feeding Individuals who have a known gene mutation associated with chronic eosinophilic leukemia Children less than 18 years old who weigh less than 48kg or 106lb Design: Participants will have a screening visit with a physical exam and medical history. Blood and urine samples will be collected. Participants will have a single dose of the steroid prednisone by mouth in the morning. Blood samples will be collected 2, 4, 24 hours after this dose. On the day after the steroid dose, participants will provide another blood sample in the morning. Participants will start to take prednisone daily when they return home. Blood samples will be collected weekly at the participant s doctor s office. The dose of prednisone will be lowered depending on the weekly eosinophil count. We will try to get each person on the lowest dose of prednisone possible that will control the disorder. Participants who do not respond or have severe side effects will be taken off prednisone. Other treatments will be considered for people who do not respond to steroids. The goal is to evaluate the response to prednisone. Our research will try to figure out why some people do not respond to steroids. Most people will complete the study within 6 to 16 weeks, depending on their response to prednisone.