Eosinophilic Asthma Clinical Trial
Official title:
Prospective Registry of Eosinophilia With Respiratory Manifestations With Translational Research Identifying and Characterizing Eosinophils
Introduction: 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:
1. 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).
2. 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.
3. 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.
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