N/A
N=120
Identification of Autoantigens in EGPA and Severe Eosinophilic Asthma
Churg-Strauss Syndrome · Eosinophilic Asthma · Eosinophilic Esophagitis · Eosinophilic Pneumonia
Bottom Line
View on ClinicalTrials.gov: NCT04671446 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Number and Percentage of Patients With a Positive Autoantibody ELISA — 19; 4; 3; 4 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Autoantibody ELISA (Diagnostic_test); Granulocyte Immunofluorescence (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Queen Mary University of London
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Percentage of Patients With a Positive Autoantibody ELISA |
19; 4; 3; 4 | — |
| SECONDARY Number and Percentage of Patients With Positive Granulocyte Immunofluorescence |
9; 1; 3 | — |
Summary
In this project the investigators will look for auto-antibodies to relevant proteins both in native form and importantly in post-translationally modified forms. Potential modified auto-antigens are eosinophil proteins (analogous to the cytoplasmic neutrophil proteins identified in vasculitides such as Granulomatosis with Polyangiitis (formerly known as Wegener's granulomatosis) and alternatively structural proteins such as collagen V. As well as advancing the understanding of asthma pathology, identifying a serum auto-antibody that could then be used as a clinical blood test, analogous to anti-cyclic citrullinated peptide (CCP) antibodies in rheumatoid arthritis, may revolutionise diagnosis of severe eosinophilic asthma and Eosinophilic Granulomatosis with Polyangiitis (EGPA). There is a considerable burden of undiagnosed severe eosinophilic asthma in part due to difficulties in definitive diagnosis and a diagnostic blood test would help diagnose these patients, allowing them to receive necessary treatment.
Eligibility Criteria
Inclusion Criteria
- Severe Eosinophilic Asthma (with multi-disciplinary diagnosis as per ERS/ATS Criteria, blood eosinophils ≥ 0.3 x109/L on inhaled corticosteroids); or
- EGPA (as per American College of Rheumatology (ACR) Criteria); or
- Eosinophilic COPD (post-bronchodilator FEV1/FVC 20 pack year smoking history, no history of asthma, blood eosinophils ≥ 0.3 x109/L); or
- Eosinophilic oesophagitis (with diagnostic histology); or
- Granulomatosis with Polyangiitis (GPA, formerly called Wegener's) (as per American College of Rheumatology (ACR) Criteria)
Exclusion Criteria
- Known Pregnancy
- Anaemia
- Hepatitis B Virus, Hepatitis C Virus or HIV infection
- Donation of more than 240mls blood in the last sixteen weeks (four months) to any other research study or as a donation to the National Blood Transfusion Service
- Rituximab, plasmapharesis or polyclonal immunoglobulin infusion (ever)
Data sourced from ClinicalTrials.gov (NCT04671446). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.