NCT04671446|CompletedResults
Identification of Autoantigens in EGPA and Severe Eosinophilic Asthma
IDEA
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IDEA
Sponsor study identifier
Secondary identifiers
OTHER · Health Research Authority
observational
120
1 country
2
Study Start
December 10, 2020
Actual (reported)Primary Completion
October 12, 2022
Actual (reported)Study Completion
May 5, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 5, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 26, 2020
Actual (reported)December 10, 2020
Actual (reported)December 17, 2020
Actual (reported)October 12, 2022
Actual (reported)May 5, 2024
Actual (reported)January 30, 2025
Actual (reported)Number and Percentage of Patients With a Positive Autoantibody ELISA
Serum tested for novel autoantibodies against candidate auto-antigens by ELISA. Outcome: Positive OD by ELISA (serum samples) to autoantigen panel (MPO, Collagen V, TREM1, IL1R2).
Baseline, at study entry
Number and Percentage of Patients With Positive Granulocyte Immunofluorescence
Baseline, at study entry
Patients with eosinophilic asthma meeting ERS/ATS criteria for severe asthma.
Milder asthma, other vasculitides, eosinophilic COPD, and/or eosinophilic oesophagitis
Healthy patients with no chronic lung condition.
Patients with asthma meeting criteria for a diagnosis of EGPA (eosinophilic granulomatosis with polyangiitis) as per Wechsler et al. \[N Engl J Med. 2017 May 18;376(20):1921-1932\]
Serum will be tested for novel autoantibodies against candidate auto-antigens by ELISA, such as those previously identified as of importance (e.g. eosinophil peroxidase, EPX) and also novel candidate proteins specific to eosinophils as identified by FANTOM5 geneset analysis.
Patients will be recruited via Outpatient Clinics conducted at St Bartholomew's (Bart's) Hospital, The Royal London Hospital, and Mile End Hospital (all Bart's Health NHS Trust), as well as from inpatients at these hospitals under the care of the Respiratory Medicine and Rheumatology teams (including those under other services needing inpatient respiratory medicine or rheumatology review).
Barts Health NHS Trust, Dept of Rheumatology, Mile End Hospital
London, E1 4DG, United Kingdom
Barts Health NHS Trust, Dept of Respiratory Medicine, St Bartholomew's Hospital
London, EC1A 7BE, United Kingdom
Esposito I, Kontra I, Giacomassi C, Manou-Stathopoulou S, Brown J, Stratton R, Verykokou G, Buccafusca R, Stevens M, Nissim A, Lewis MJ, Pfeffer PE. Identification of autoantigens and their potential post-translational modification in EGPA and severe eosinophilic asthma. Front Immunol. 2023 Jun 2;14:1164941. doi: 10.3389/fimmu.2023.1164941. eCollection 2023.
Blood samples
Myles J Lewis, MD PhD FRCP
Queen Mary University of London
Paul Pfeffer, MD
Barts & The London NHS Trust
120 participants (actual enrollment reported by the registry).
First Submitted
October 26, 2020
First Posted
December 17, 2020
Study Start
December 10, 2020
Actual (reported)Eosinophilic Oesophagitis Assessment With String Testing
The presence of auto-antibodies in patient serum to inactive and activated neutrophils / eosinophils, with and without post-translational modification, will be examined by indirect immunofluorescence.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
October 12, 2022
Actual (reported)Study Completion
May 5, 2024
Actual (reported)Last Updated
January 30, 2025
Results First Posted
January 30, 2025
Record last verified: 2024-12
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Source: ClinicalTrials.gov.
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