Registry

Registry Progress

Last updated: 30th August 2019

The target for prospective patient recruitment by 2022 is 13,150 patients with severe asthma.

ISAR Country Leads

CountryLead
ArgentinaJorge Maspero
AustraliaPeter G. Gibson
BulgariaGeorge C. Christoff
CanadaJ. Mark Fitzgerald
ColombiaCarlos Torres
DenmarkCeleste Porsbjerg
EstoniaAlan Altraja
FinlandLauri Lehtimäki
France

Arnaud Bourdin

Camille Taille

GermanyRoland Buhl
GreeceAndriana I. Papaioannou
IcelandUnnur Björnsdóttir
IndiaSundeep Salvi
IrelandRichard W. Costello
CountryLead
Italy

Georgio Walter Canonica

Enrico Heffler

JapanTakashi Iwanaga
KuwaitMona Al-Ahmad
MexicoDésirée Larenas Linnemann
NetherlandsAnke-Hilse Maitland- van der Zee
Saudi ArabiaMajdy Idrees
South KoreaChin Kook Rhee
SpainLuis Perez-de-Llano
SwedenLeif Bjermer
TaiwanSteve Perng
UAEBassam Mahboub
UK

Andrew Menzies-Gow

Liam G. Heaney

USAEileen Wang

The Registry

The ISAR initiative will provide support for data collection across all participating countries. The fully developed ISAR EDC system running on the OpenClinica Platform is freely available to countries participating with the ISAR registry.

The ISAR registry includes the following data areas:

  • Patient details
  • Occupation
  • Comorbidity
  • Blood/Sputum
  • Medical History
  • Adherence
  • Diagnostics
  • Lung function
  • Allergen Testing
  • Asthma Control
  • Asthma Medication
  • Safety: Cancer, Serious infection and Anaphylaxis​​
  • Effectiveness: Exacerbation details, ICS/OCS dose, Reason for medication switch
  • Treatment Management Plan
  • Optional Research Variables: Occupation, Medical History, Additional Comorbidities, Additional Diagnostics, Additional Lung Function Test, Asthma Control, Quality of Life/Depression & Anxiety Questionnaire, Asthma Medication, Pediatric Severe Asthma

Inclusion Criteria

• According to 2018 definitions of the Global Initiative for Asthma (GINA) Step 5 treatment; or

• GINA Step 4 treatment and uncontrolled asthma (as outlined by American Thoracic Society/European Respiratory Society guidelines below:)

1.Poor symptom control: ACQ > 1.5, ACT <20 (or ‘‘not well controlled’’ by National Asthma Education and Prevention Program/GINA guidelines)

2.Frequent severe exacerbations: two or more bursts of systemic CS (>3 days each) in the previous year

3.Serious exacerbations: at least one hospitalisation, ICU stay or mechanical ventilation in the previous year

4.Airflow limitation: after appropriate bronchodilator withhold FEV1 <80% predicted (in the face of reduced FEV1/FVC defined as less than the lower limit of normal)

Current National Registries

Countries with existing and well established registries will be supported with extractions of the required data from their home registries for ISAR.

The existing registries include:

CountryRegistryOrganisationLink
UKUK Severe Asthma Network and National Registry on Difficult Asthma University of BelfastView
GermanyGerman Asthma Net (GAN)German Asthma NetView
ItalySevere/Uncontrolled Asthma Registry (SUA)Italian Severe Asthma Network (SANI)View
AustraliaSAWD Severe Asthma Web based DatabaseAustralasian Severe Asthma Network (ASAN)View

Linking Severe Asthma Registries to
Primary Care Electronic Health Records

United Kingdom

The Optimum Patient Care Research Database (OPCRD) is a bespoke database with focus on patient-reported outcomes that contains anonymous data from over 700 UK general practices across England, Scotland, Wales, and Northern Ireland. The database contains both longitudinal medical records and, for approximately 10% of patients with asthma and COPD, the results of patient-completed questionnaires. Hashed NHS identifiers can be obtained for all patients in this database during the anonymised data extraction process. The ability to link severe asthma registry data with data in primary care databases such as the OPCRD, will be an added advantage and allow in-depth characterisation of:

      • Healthcare resource use
      • Medical history and comorbidities
      • Medication use, including adherence and persistence

To learn more about the OPCRD please click here.