The Registry

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

What is ISAR?

The International Severe Asthma Registry (ISAR) is the first global severe asthma registry; a joint initiative where national registries (both newly created and pre-existing) retain ownership of their own data but open their borders and share data with ISAR for ethically approved research.

The ISAR initiative is conducted by Optimum Patient Care (OPC) Global Limited, with scientific oversight from the ISAR Core Steering Committee (ISC), academic support from the Respiratory Effectiveness Group (REG), ethical governance from the Anonymized Data Ethics & Protocol Committee (ADEPT), and co-funded by OPC Global and AstraZeneca since May 2017.

Why ISAR?

By collecting anonymised, high-quality patient-level data via a standardised core set of variables from countries all over the world, ISAR is able to fill the need for a longitudinal, real-life, globally interoperable severe asthma registry.

Bolstered by a collaborative organizational structure, the network of database and clinical experts, and its principle of inclusivity/openness with regards to research, ISAR provides the statistical power and opportunity to better understand severe asthma epidemiology across countries and regions and answer important research questions while ensuring the scientific integrity and clinical applicability of the database and its research. Ultimately, ISAR offers an unique opportunity to implement existing knowledge to generate new knowledge by identifying the unknown; thus, driving new research in the severe asthma disease area.

What is collected in ISAR?

Collated by the ISAR network of respiratory and database experts via the Delphi iterative decision making process, ISAR captures the following information: Demographics, Medical History, Comorbidities, Diagnostics, Hospital Resource Utilization, Biomarkers (Blood and Sputum Eosinophils, IgE, FeNO), Asthma Medication, Allergy Tests, Asthma Control (GINA Assessment for asthma control), Adherence and Clinical Management Plan.

ISAR also collects safety-related data across three main events: Cancer, Serious Infections and Anaphylaxis and medication effectiveness data across ten OCS related comorbidities (Osteoporosis, Diabetes, Renal Failure, Anxiety, Depression, Peptic Ulcer, Cataract, Glaucoma, Pneumonia, Cardiovascular Diseases, Obstructive Sleep Apnoea) as well as OCS/ICS doses and reasons for switching from/to/between biologics.

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

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:)

Poor symptom control: ACQ >1.5, ACT <20 (or ‘‘not well controlled’’ by National Asthma Education and Prevention Program/GINA guidelines)
Frequent severe exacerbations: two or more bursts of systemic CS (>3 days each) in the previous year
Serious exacerbations: at least one hospitalisation, ICU stay or mechanical ventilation in the previous year
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)