International Severe Asthma Registry (ISAR)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Effectiveness study (incl. comparative)
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Registry Study, multi-country, multicentre, observational initiative which will retrospectively and prospectively collect data regarding severe asthma patients

Study drug and medical condition

• Medical condition to be studied:
  Asthma

Population studied

• Short description of the study population:
  Patients receiving care at severe asthma secondary and tertiary care centres in each participating country in accordance with local regulatory/ethical requirements.; ; Inclusion Criteria; • Patients 18 years or older; • Patients in receiving treatment according to GINA Step 5 or uncontrolled in Step 4. Uncontrolled is defined as having severe asthma symptoms or frequent exacerbations
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Asthma patients
• Estimated number of subjects:
  34394

Study design details

• Main study objective:
  Describe and characterise the severe asthma patient population natural history overall where appropriate and by different subgroups (e.g. by age, sex, etc)Facilitate the phenotyping and endotyping of patients with severe asthma and to describe these groups by the burden of illness, disease management patterns and clinical evolution in these patient populations in an international setting.
• Data analysis plan:
  Describing the natural history of severe asthmaPhenotyping severe asthma sub-groupsExamining significant predictors of clinical outcomes