Trial Outcomes & Findings for Identification of Autoantigens in EGPA and Severe Eosinophilic Asthma (NCT NCT04671446)
NCT ID: NCT04671446
Last Updated: 2025-01-30
Results Overview
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).
COMPLETED
120 participants
Baseline, at study entry
2025-01-30
Participant Flow
Participant milestones
| Measure |
Severe Eosinophilic Asthma
Patients with eosinophilic asthma meeting ERS/ATS criteria for severe asthma.
|
Healthy Controls
Healthy patients with no chronic lung condition.
|
EGPA
Patients with asthma meeting criteria for a diagnosis of EGPA (eosinophilic granulomatosis with polyangiitis)
|
Other Respiratory Conditions
Mild-to-moderate asthma, other vasculitides, eosinophilic COPD, and/or eosinophilic oesophagitis
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
63
|
30
|
17
|
10
|
|
Overall Study
COMPLETED
|
63
|
30
|
17
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age for one healthy control not available.
Baseline characteristics by cohort
| Measure |
Severe Eosinophilic Asthma
n=63 Participants
Patients with eosinophilic asthma meeting ERS/ATS criteria for severe asthma.
|
Healthy Controls
n=30 Participants
Healthy patients with no chronic lung condition.
|
EGPA
n=17 Participants
Patients with asthma meeting criteria for a diagnosis of EGPA (eosinophilic granulomatosis with polyangiitis)
|
Other Respiratory Conditions
n=10 Participants
Mild-to-moderate asthma, other vasculitides, eosinophilic COPD, and/or eosinophilic oesophagitis
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=63 Participants • Age for one healthy control not available.
|
0 Participants
n=29 Participants • Age for one healthy control not available.
|
0 Participants
n=17 Participants • Age for one healthy control not available.
|
0 Participants
n=10 Participants • Age for one healthy control not available.
|
0 Participants
n=119 Participants • Age for one healthy control not available.
|
|
Age, Categorical
Between 18 and 65 years
|
54 Participants
n=63 Participants • Age for one healthy control not available.
|
28 Participants
n=29 Participants • Age for one healthy control not available.
|
13 Participants
n=17 Participants • Age for one healthy control not available.
|
5 Participants
n=10 Participants • Age for one healthy control not available.
|
100 Participants
n=119 Participants • Age for one healthy control not available.
|
|
Age, Categorical
>=65 years
|
9 Participants
n=63 Participants • Age for one healthy control not available.
|
1 Participants
n=29 Participants • Age for one healthy control not available.
|
4 Participants
n=17 Participants • Age for one healthy control not available.
|
5 Participants
n=10 Participants • Age for one healthy control not available.
|
19 Participants
n=119 Participants • Age for one healthy control not available.
|
|
Age, Continuous
|
54.4 years
STANDARD_DEVIATION 12.3 • n=63 Participants • Age for one Healthy control patient not available
|
42.0 years
STANDARD_DEVIATION 14.1 • n=29 Participants • Age for one Healthy control patient not available
|
56.6 years
STANDARD_DEVIATION 14.2 • n=17 Participants • Age for one Healthy control patient not available
|
63.1 years
STANDARD_DEVIATION 9.7 • n=10 Participants • Age for one Healthy control patient not available
|
52.4 years
STANDARD_DEVIATION 14.2 • n=119 Participants • Age for one Healthy control patient not available
|
|
Sex: Female, Male
Female
|
29 Participants
n=63 Participants
|
16 Participants
n=30 Participants
|
7 Participants
n=17 Participants
|
4 Participants
n=10 Participants
|
56 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=63 Participants
|
14 Participants
n=30 Participants
|
10 Participants
n=17 Participants
|
6 Participants
n=10 Participants
|
64 Participants
n=120 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White
|
31 Participants
n=63 Participants
|
16 Participants
n=30 Participants
|
12 Participants
n=17 Participants
|
6 Participants
n=10 Participants
|
65 Participants
n=120 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Asian
|
16 Participants
n=63 Participants
|
9 Participants
n=30 Participants
|
0 Participants
n=17 Participants
|
4 Participants
n=10 Participants
|
29 Participants
n=120 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Black
|
8 Participants
n=63 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=17 Participants
|
0 Participants
n=10 Participants
|
10 Participants
n=120 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other / Declined / Not Available
|
8 Participants
n=63 Participants
|
5 Participants
n=30 Participants
|
3 Participants
n=17 Participants
|
0 Participants
n=10 Participants
|
16 Participants
n=120 Participants
|
|
Region of Enrollment
United Kingdom
|
63 participants
n=63 Participants
|
30 participants
n=30 Participants
|
17 participants
n=17 Participants
|
10 participants
n=10 Participants
|
120 participants
n=120 Participants
|
PRIMARY outcome
Timeframe: Baseline, at study entryPopulation: EGPA and Other respiratory conditions arms included as reference populations, with some patients purposefully recruited due to known anti-MPO status (potential selection bias). 17 Severe eosinophilic asthma patients, 5 Healthy control participants, 5 EGPA patients and 3 patients with Other Respiratory Conditions excluded from outcome due to technical errors with ELISA assays (missing data).
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).
Outcome measures
| Measure |
Severe Eosinophilic Asthma
n=46 Participants
Patients with eosinophilic asthma meeting ERS/ATS criteria for severe asthma.
|
Healthy Controls
n=25 Participants
Healthy patients with no chronic lung condition.
|
EGPA
n=12 Participants
Patients with asthma meeting criteria for a diagnosis of EGPA (eosinophilic granulomatosis with polyangiitis)
|
Other Respiratory Conditions
n=7 Participants
Mild-to-moderate asthma, other vasculitides, eosinophilic COPD, and/or eosinophilic oesophagitis
|
|---|---|---|---|---|
|
Number and Percentage of Patients With a Positive Autoantibody ELISA
|
19 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline, at study entryPopulation: EGPA and Other respiratory conditions arms included as reference populations, with some patients purposefully recruited due to known anti-MPO status (potential selection bias). 46 Severe eosinophilic asthma patients, 23 Healthy control participants, 12 EGPA patients and 10 patients with Other Respiratory Conditions excluded from outcome due to missing data (only limited samples were tested).
FITC anti-IgG immunofluorescence with slides of unstimulated/PMA-stimulated neutrophils (serum samples)
Outcome measures
| Measure |
Severe Eosinophilic Asthma
n=17 Participants
Patients with eosinophilic asthma meeting ERS/ATS criteria for severe asthma.
|
Healthy Controls
n=7 Participants
Healthy patients with no chronic lung condition.
|
EGPA
n=5 Participants
Patients with asthma meeting criteria for a diagnosis of EGPA (eosinophilic granulomatosis with polyangiitis)
|
Other Respiratory Conditions
Mild-to-moderate asthma, other vasculitides, eosinophilic COPD, and/or eosinophilic oesophagitis
|
|---|---|---|---|---|
|
Number and Percentage of Patients With Positive Granulocyte Immunofluorescence
|
9 Participants
|
1 Participants
|
3 Participants
|
—
|
POST_HOC outcome
Timeframe: Baseline, at study entryPopulation: Peripheral blood samples for sequencing were only available for a proportion of participants. 60 participants were chosen for this post-hoc analysis to represent a range of SEA/EGPA patients and healthy controls. Sequencing from 1 sample did not reach quality control criteria resulting in 59 samples reported. No participants with Other respiratory conditions were analysed for this post-hoc outcome as these were not the population of interest for this post-hoc outcome measure.
Peripheral blood B Cell Receptor (BCR) bulkRNA repertoire sequencing
Outcome measures
| Measure |
Severe Eosinophilic Asthma
n=31 Participants
Patients with eosinophilic asthma meeting ERS/ATS criteria for severe asthma.
|
Healthy Controls
n=16 Participants
Healthy patients with no chronic lung condition.
|
EGPA
n=12 Participants
Patients with asthma meeting criteria for a diagnosis of EGPA (eosinophilic granulomatosis with polyangiitis)
|
Other Respiratory Conditions
Mild-to-moderate asthma, other vasculitides, eosinophilic COPD, and/or eosinophilic oesophagitis
|
|---|---|---|---|---|
|
Percentage of Total Unique BCR Sequences Being of IgA1 Subclass
|
0.89 Percentage of unique BCR sequences
Standard Deviation 0.58
|
0.82 Percentage of unique BCR sequences
Standard Deviation 0.48
|
1.68 Percentage of unique BCR sequences
Standard Deviation 1.07
|
—
|
POST_HOC outcome
Timeframe: Baseline, at study entryPopulation: Peripheral blood samples for sequencing were only available for a proportion of participants. 60 participants were chosen for this post-hoc analysis to represent a range of SEA/EGPA patients and healthy controls. Sequencing from 1 sample did not reach quality control criteria resulting in 59 samples reported. No participants with Other respiratory conditions were analysed for this post-hoc outcome as these were not the population of interest for this post-hoc outcome measure.
Peripheral blood B Cell Receptor (BCR) bulkRNA repertoire sequencing
Outcome measures
| Measure |
Severe Eosinophilic Asthma
n=31 Participants
Patients with eosinophilic asthma meeting ERS/ATS criteria for severe asthma.
|
Healthy Controls
n=16 Participants
Healthy patients with no chronic lung condition.
|
EGPA
n=12 Participants
Patients with asthma meeting criteria for a diagnosis of EGPA (eosinophilic granulomatosis with polyangiitis)
|
Other Respiratory Conditions
Mild-to-moderate asthma, other vasculitides, eosinophilic COPD, and/or eosinophilic oesophagitis
|
|---|---|---|---|---|
|
Percentage of Total Unique BCR Sequences Being of IgA2 Subclass
|
1.33 Percentage of unique BCR sequences
Standard Deviation 1.18
|
0.85 Percentage of unique BCR sequences
Standard Deviation 0.48
|
1.59 Percentage of unique BCR sequences
Standard Deviation 1.23
|
—
|
POST_HOC outcome
Timeframe: Baseline, at study entryPopulation: Peripheral blood samples for sequencing were only available for a proportion of participants. 60 participants were chosen for this post-hoc analysis to represent a range of SEA/EGPA patients and healthy controls. Sequencing from 1 sample did not reach quality control criteria resulting in 59 samples reported. No participants with Other respiratory conditions were analysed for this post-hoc outcome as these were not the population of interest for this post-hoc outcome measure.
Peripheral blood B Cell Receptor (BCR) bulkRNA repertoire sequencing
Outcome measures
| Measure |
Severe Eosinophilic Asthma
n=31 Participants
Patients with eosinophilic asthma meeting ERS/ATS criteria for severe asthma.
|
Healthy Controls
n=16 Participants
Healthy patients with no chronic lung condition.
|
EGPA
n=12 Participants
Patients with asthma meeting criteria for a diagnosis of EGPA (eosinophilic granulomatosis with polyangiitis)
|
Other Respiratory Conditions
Mild-to-moderate asthma, other vasculitides, eosinophilic COPD, and/or eosinophilic oesophagitis
|
|---|---|---|---|---|
|
Percentage of Total Unique BCR Sequences Being of IgG1 Subclass
|
2.52 Percentage of unique BCR sequences
Standard Deviation 2.18
|
2.05 Percentage of unique BCR sequences
Standard Deviation 1.36
|
2.90 Percentage of unique BCR sequences
Standard Deviation 1.34
|
—
|
POST_HOC outcome
Timeframe: Baseline, at study entryPopulation: Peripheral blood samples for sequencing were only available for a proportion of participants. 60 participants were chosen for this post-hoc analysis to represent a range of SEA/EGPA patients and healthy controls. Sequencing from 1 sample did not reach quality control criteria resulting in 59 samples reported. No participants with Other respiratory conditions were analysed for this post-hoc outcome as these were not the population of interest for this post-hoc outcome measure.
Peripheral blood B Cell Receptor (BCR) bulkRNA repertoire sequencing
Outcome measures
| Measure |
Severe Eosinophilic Asthma
n=31 Participants
Patients with eosinophilic asthma meeting ERS/ATS criteria for severe asthma.
|
Healthy Controls
n=16 Participants
Healthy patients with no chronic lung condition.
|
EGPA
n=12 Participants
Patients with asthma meeting criteria for a diagnosis of EGPA (eosinophilic granulomatosis with polyangiitis)
|
Other Respiratory Conditions
Mild-to-moderate asthma, other vasculitides, eosinophilic COPD, and/or eosinophilic oesophagitis
|
|---|---|---|---|---|
|
Percentage of Total Unique BCR Sequences Being of IgG2 Subclass
|
7.86 Percentage of unique BCR sequences
Standard Deviation 9.46
|
3.15 Percentage of unique BCR sequences
Standard Deviation 1.50
|
8.37 Percentage of unique BCR sequences
Standard Deviation 9.20
|
—
|
POST_HOC outcome
Timeframe: Baseline, at study entryPopulation: Peripheral blood samples for sequencing were only available for a proportion of participants. 60 participants were chosen for this post-hoc analysis to represent a range of SEA/EGPA patients and healthy controls. Sequencing from 1 sample did not reach quality control criteria resulting in 59 samples reported. No participants with Other respiratory conditions were analysed for this post-hoc outcome as these were not the population of interest for this post-hoc outcome measure.
Peripheral blood B Cell Receptor (BCR) bulkRNA repertoire sequencing
Outcome measures
| Measure |
Severe Eosinophilic Asthma
n=31 Participants
Patients with eosinophilic asthma meeting ERS/ATS criteria for severe asthma.
|
Healthy Controls
n=16 Participants
Healthy patients with no chronic lung condition.
|
EGPA
n=12 Participants
Patients with asthma meeting criteria for a diagnosis of EGPA (eosinophilic granulomatosis with polyangiitis)
|
Other Respiratory Conditions
Mild-to-moderate asthma, other vasculitides, eosinophilic COPD, and/or eosinophilic oesophagitis
|
|---|---|---|---|---|
|
Percentage of Total Unique BCR Sequences Being of IgG3 Subclass
|
0.60 Percentage of unique BCR sequences
Standard Deviation 0.55
|
0.69 Percentage of unique BCR sequences
Standard Deviation 0.79
|
0.68 Percentage of unique BCR sequences
Standard Deviation 0.58
|
—
|
POST_HOC outcome
Timeframe: Baseline, at study entryPopulation: Peripheral blood samples for sequencing were only available for a proportion of participants. 60 participants were chosen for this post-hoc analysis to represent a range of SEA/EGPA patients and healthy controls. Sequencing from 1 sample did not reach quality control criteria resulting in 59 samples reported. No participants with Other respiratory conditions were analysed for this post-hoc outcome as these were not the population of interest for this post-hoc outcome measure.
Peripheral blood B Cell Receptor (BCR) bulkRNA repertoire sequencing
Outcome measures
| Measure |
Severe Eosinophilic Asthma
n=31 Participants
Patients with eosinophilic asthma meeting ERS/ATS criteria for severe asthma.
|
Healthy Controls
n=16 Participants
Healthy patients with no chronic lung condition.
|
EGPA
n=12 Participants
Patients with asthma meeting criteria for a diagnosis of EGPA (eosinophilic granulomatosis with polyangiitis)
|
Other Respiratory Conditions
Mild-to-moderate asthma, other vasculitides, eosinophilic COPD, and/or eosinophilic oesophagitis
|
|---|---|---|---|---|
|
Percentage of Total Unique BCR Sequences Being of IgG4 Subclass
|
0.059 Percentage of unique BCR sequences
Standard Deviation 0.10
|
0.011 Percentage of unique BCR sequences
Standard Deviation 0.0086
|
0.051 Percentage of unique BCR sequences
Standard Deviation 0.048
|
—
|
POST_HOC outcome
Timeframe: Baseline, at study entryPopulation: Peripheral blood samples for sequencing were only available for a proportion of participants. 60 participants were chosen for this post-hoc analysis to represent a range of SEA/EGPA patients and healthy controls. Sequencing from 1 sample did not reach quality control criteria resulting in 59 samples reported. No participants with Other respiratory conditions were analysed for this post-hoc outcome as these were not the population of interest for this post-hoc outcome measure.
Peripheral blood B Cell Receptor (BCR) bulkRNA repertoire sequencing
Outcome measures
| Measure |
Severe Eosinophilic Asthma
n=31 Participants
Patients with eosinophilic asthma meeting ERS/ATS criteria for severe asthma.
|
Healthy Controls
n=16 Participants
Healthy patients with no chronic lung condition.
|
EGPA
n=12 Participants
Patients with asthma meeting criteria for a diagnosis of EGPA (eosinophilic granulomatosis with polyangiitis)
|
Other Respiratory Conditions
Mild-to-moderate asthma, other vasculitides, eosinophilic COPD, and/or eosinophilic oesophagitis
|
|---|---|---|---|---|
|
Percentage of Total Unique BCR Sequences Being of IgE Subclass
|
0.017 Percentage of unique BCR sequences
Standard Deviation 0.012
|
0.0060 Percentage of unique BCR sequences
Standard Deviation 0.0029
|
0.039 Percentage of unique BCR sequences
Standard Deviation 0.040
|
—
|
Adverse Events
Severe Eosinophilic Asthma
Healthy Controls
EGPA
Other Respiratory Conditions
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Myles Lewis, Dr Paul Pfeffer
Queen Mary University of London
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place