NCT03036670

Brief Summary

EGPA (Eosinophilic Granulomatosis with Polyangiitis, previously Churg-Strauss syndrome) is a rare vasculitis, characterised by asthma, rhinosinusitis and eosinophilia. There has previously been confusion around diagnostic criteria, with multiple sets of classification criteria being used inappropriately for diagnosis. The ERS formed a taskforce to produce specific diagnostic criteria, and these divided the Churg-Strauss Syndrome cohort into two groups - vasculitic EGPA and tissular Hypereosinophilic Asthma with Systemic Manifestations (HASM). It is not known if the groups separated by the diagnostic criteria are also separated in clinical symptomatology, or if their disease course varies, and this could have significant impact on management and further research.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 30, 2017

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2017

Completed
Last Updated

April 7, 2023

Status Verified

April 1, 2023

Enrollment Period

6 months

First QC Date

September 26, 2016

Last Update Submit

April 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diagnosis according to various diagnostic criteria

    The diagnosis of each participant according to different diagnostic or classification criteria (ERS-CSS, Chapel Hill, ACR, Lanham) based on all test results available between the point of diagnosis and 60 months later

    From date of diagnosis for 5 years

Secondary Outcomes (6)

  • Corticosteroid dose

    From date of diagnosis for 5 years

  • Immunosuppressive medication

    From date of diagnosis for 5 years

  • Comorbid conditions

    From date of diagnosis for 5 years

  • Biopsy findings

    From date of diagnosis for 5 years

  • Relapse rates

    From date of diagnosis for 5 years

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study participants are adults with Churg-Strauss syndrome under the care of Portsmouth Hospitals NHS Trust.

You may qualify if:

  • Male or Female, aged 18 years or above.
  • Cared for currently or previously cared for at Portsmouth Hospitals NHS Trust
  • Diagnosed with EGPA/HASM according to clinicians

You may not qualify if:

  • \- Medical notes not obtainable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Alexandra Hospital

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

MeSH Terms

Conditions

Churg-Strauss Syndrome

Condition Hierarchy (Ancestors)

Anti-Neutrophil Cytoplasmic Antibody-Associated VasculitisSystemic VasculitisVasculitisVascular DiseasesCardiovascular DiseasesGranulomaLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Anoop J Chauhan, PhD FRCP

    Portsmouth Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2016

First Posted

January 30, 2017

Study Start

August 10, 2016

Primary Completion

January 31, 2017

Study Completion

January 31, 2017

Last Updated

April 7, 2023

Record last verified: 2023-04

Locations