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Eosinophilic Granulomatosis With Polyangiitis Cohort (EGPA Cohort)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03036670
Recruitment Status : Unknown
Verified September 2017 by Portsmouth Hospitals NHS Trust.
Recruitment status was:  Recruiting
First Posted : January 30, 2017
Last Update Posted : September 20, 2017
Information provided by (Responsible Party):
Portsmouth Hospitals NHS Trust

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.

Condition or disease
Churg-Strauss Syndrome

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Eosinophilic Granulomatosis With Polyangiitis Cohort
Study Start Date : September 2016
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : December 2017

Primary Outcome Measures :
  1. Diagnosis according to various diagnostic criteria [ Time Frame: From date of diagnosis for 5 years ]
    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

Secondary Outcome Measures :
  1. Corticosteroid dose [ Time Frame: From date of diagnosis for 5 years ]
    Stable doses (taken for ≥4 weeks) of oral and inhaled corticosteroids at diagnosis and 12 monthly up to 5 years

  2. Immunosuppressive medication [ Time Frame: From date of diagnosis for 5 years ]
    Which additional immunosuppressive medication had been given and when

  3. Comorbid conditions [ Time Frame: From date of diagnosis for 5 years ]
    List of comorbidities

  4. Biopsy findings [ Time Frame: From date of diagnosis for 5 years ]
    List of Biopsy results

  5. Relapse rates [ Time Frame: From date of diagnosis for 5 years ]
    Rate of relapses or flares

  6. Peak disease activity [ Time Frame: From date of diagnosis for 5 years ]
    maximum disease activity from diagnosis to 5 years as defined by BVAS score and VDI score

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study participants are adults with Churg-Strauss syndrome under the care of Portsmouth Hospitals NHS Trust.

Inclusion Criteria:

  • 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

Exclusion Criteria:

- Medical notes not obtainable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03036670

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Contact: Thomas L Jones, MB BChir 02392286000 ext 5154
Contact: Anoop J Chauhan, PhD FRCP 02392286000 ext 5154

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United Kingdom
Queen Alexandra Hospital Recruiting
Portsmouth, Hampshire, United Kingdom, PO6 3LY
Sponsors and Collaborators
Portsmouth Hospitals NHS Trust
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Principal Investigator: Anoop J Chauhan, PhD FRCP Portsmouth Hospitals NHS Trust

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Responsible Party: Portsmouth Hospitals NHS Trust Identifier: NCT03036670    
Other Study ID Numbers: PHT/2015/130
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Granulomatosis with Polyangiitis
Systemic Vasculitis
Churg-Strauss Syndrome
Vascular Diseases
Cardiovascular Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Autoimmune Diseases
Immune System Diseases
Lymphoproliferative Disorders
Lymphatic Diseases