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

Adults (18 to < 46 years)
Adults (46 to < 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