Registry Progress
The target for prospective patient recruitment by 2022 is 13,150 patients with severe asthma.
ISAR Country Leads
| Country | Lead |
|---|---|
| Argentina | Jorge Maspero |
| Australia | Matthew Peters |
| Brazil | Paulo Pitrez |
| Bulgaria | George C. Christoff |
| Canada | J. Mark FitzGerald |
| Colombia | Carlos A. Torres-Duque |
| Denmark | Celeste M. Porsbjerg |
| Estonia | Alan Altraja |
| Finland | Lauri A. Lehtimäki |
| France | Arnaud Bourdin Camille Taillé |
| Germany | Christian Taube |
| Greece | Andriana I. Papaioannou |
| Iceland | Dora Lúðvíksdóttir Unnur Steina Björnsdóttir |
| India | Sundeep Salvi |
| Ireland | Richard W. Costello |
| Italy | Giorgio Walter Canonica Enrico Heffler |
| Japan | Takashi Iwanaga |
| Kuwait | Mona Al-Ahmad |
| Mexico | Désirée Larenas-Linnemann |
| The Netherlands | Elisabeth Bel Anke-Hilse Maitland-van der Zee |
| Poland | Piotr Kuna |
| Portugal | João A. Fonseca Ana Sá e Sousa |
| Russia | Andrey Belevskiy |
| Saudi Arabia | Riyad Al-Lehebi |
| Singapore | Mariko Koh Siyue Sanjay Chotirmall |
| South Korea | Chin Kook Rhee Kwang Ha Yoo |
| Spain | Luis Perez-de-Llano |
| Sweden | David Aronsson |
| Taiwan | Ko Hsin-Kuo (Bruce) |
| UAE | Bassam Mahboub |
| UK | Andrew N. Menzies-Gow Liam G. Heaney |
| USA | Eileen 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:
| Country | Registry | Organisation | Link |
|---|---|---|---|
| UK | UK Severe Asthma Network and National Registry on Difficult Asthma | University of Belfast | View |
| Germany | German Asthma Net (GAN) | German Asthma Net | View |
| Italy | Severe/Uncontrolled Asthma Registry (SUA) | Italian Severe Asthma Network (SANI) | View |
| Australia | SAWD Severe Asthma Web based Database | Australasian 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.