Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - Severe Eosinophilic Asthma (with multi-disciplinary diagnosis as per ERS/ATS Criteria, <20 pack year smoking history, 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 < 70% predicted, absence of bronchodilator reversibility, > 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Queen Mary University of London|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Myles J Lewis, MD PhD FRCPPaul Pfeffer, MD|
|Principal Investigator Affiliation||Queen Mary University of LondonBarts & The London NHS Trust|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Churg-Strauss Syndrome, Eosinophilic Asthma, Eosinophilic Esophagitis, Eosinophilic Pneumonia|
The investigators will approach the research question with parallel agnostic and targeted approaches. In the agnostic approach the presence of auto-antibodies in patient serum and sputum to inactive and activated eosinophils, with and without post-translational modification, will be examined by indirect immunofluorescence. In the targeted approach the investigators will examine by enzyme-linked immunoassay (ELISA) the presence/absence of antibodies to pre-selected candidate eosinophil and base membrane proteins both in native form and post-translationally modified. Proteins to examine will be chosen based on literature review (e.g. eosinophil peroxidase and collagen V) and eosinophil-specific proteins identified by FANTOM5 (Functional Annotation of the Mouse/Mammalian Genome) geneset analysis (FANTOM Consortium et al. 2014). Both blood and sputum samples from highly-characterised patients with severe eosinophilic asthma and/or EGPA will be examined given the possibility of compartment-specific immune responses. Once candidate auto-antigens have been identified in the selected group of patients with severe eosinophilic asthma and EGPA, the investigators will then examine their prevalence in serum samples from a wider selection of patients with eosinophilic airways diseases including mild-to-moderate asthma, severe eosinophilic asthma, EGPA, nasal polyposis and eosinophilic chronic obstructive pulmonary disease (COPD) as well as healthy controls. Length of disease, atopy, presence/absence nasal polyps, gender, age will be examined as co-variates. Correlations with highest blood eosinophil counts, requirement for oral corticosteroids and presence of other auto-antibodies, e.g. anti-MPO (myeloperoxidase) ANCA (anti-neutrophil cytoplasmic antibody), will be examined. In particular the investigators will look for the presence of novel autoantibodies in specific patient subsets: i) ANCA negative, ii) ANCA positive by immunofluorescence but negative for anti-MPO and anti-PR3 (proteinase-3) antibodies, iii) ANA (anti-nuclear antibody) positive but ANCA and extractable nuclear antigen (ENA) negative; since patients in all three groups may have novel, as yet undetermined autoantibodies. ROC (receiver operator characteristic curve) AUC (area under curve) analyses will be conducted to ascertain the predictive value of blood auto-antibodies for diagnosis of eosinophilic airways disease.
: Severe eosinophilic asthma and/or EGPA
: Other respiratory conditions
Milder asthma, other vasculitides, eosinophilic COPD, and/or eosinophilic oesophagitis
: Healthy controls
Diagnostic Test: - Autoantibody ELISA
Serum will be tested for novel autoantibodies against eosinophil proteins by ELISA, such as those previously identified as of importance (e.g. eosinophil-peroxidase, EPX) and also novel candidate proteins specific to eosinophils (including ARFIP1, BCL2A1, PPCDC, SLC12A6 etc) as identified by FANTOM5 geneset analysis.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.