Prospective Registry of Eosinophilia With Respiratory Manifestations With Translational Research Identifying and Characterizing Eosinophils

NCT04538937 | Recruiting

• 1 other identifier: 20200303-2218
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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. 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.

Conditions

Eosinophilic Asthma; EGPA - Eosinophilic Granulomatosis With Polyangiitis; Samter Triad; HES - Hypereosinophilic Syndrome; Eosinophilic Pneumonia

Outcome Measures

Primary Outcomes (2)

• Establishment of a registry and descriptive characterization of the collective (frequencies of the individual types of disease, frequencies of the forms of therapy, documentation of the clinical course).

  10 years

• Identification of inflammatory and regulatory eosinophils in peripheral blood by FACS analysis in all subtypes of eosinophilic manifestations of the respiratory tract

  1 year

Study Arms (2)

Subjects with eosinophilia and respiratory manifestation

Other: no intervention

Healthy subjects

Other: no intervention

Interventions

no intervention OTHER

no intervention

Healthy subjects; Subjects with eosinophilia and respiratory manifestation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients suffering from severe, late-onset non-atopic eosinophilic asthma bronchiale on mepolizumab therapy or with planned mepolizumab therapy, recruited at our Dept. of Internal Medicine 2, Pneumology, Innsbruck Medical University.

You may qualify if:

• age ≥ 18 years
• documented blood eosinophilia ≥ 300 cells/µl
• present tissue damage of the respiratory tract caused by eosinophils

You may not qualify if:

• age \< 18 years
• pregnancy
• dementia
• incapacitated patients

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

University Clinic for Internal Medicine II

Innsbruck, 6020, Austria

RECRUITING

MeSH Terms

Conditions

Pulmonary Eosinophilia; Churg-Strauss Syndrome; Hypereosinophilic Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Granuloma; Lymphoproliferative Disorders; Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Ivan Tancevski, MD

CONTACT

+43 50504 81602; ivan.tancevski@i-med.ac.at

Judith Löffler-Ragg

CONTACT

+43 50504 81413; judith.loeffler@i-med.ac.at

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: September 4, 2020
• Study Start: February 26, 2020
• Primary Completion: February 26, 2021
• Study Completion (Estimated): February 26, 2030
• Last Updated: September 4, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)