Study type

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medical condition to be studied

Asthma
Population studied

Age groups

Adolescents (12 to < 18 years)
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)

Estimated number of subjects

7200
Study design details

Main study objective

To study the effectiveness of initiating patients with high blood eosinophil counts on high ICS doses to reduce future exacerbation risk and to achieve asthma cont

Outcomes

Number of severe asthma exacerbations, Acute oral corticosteroid courses for respiratory conditionsHospitalizations for asthma exacerbationAcute respiratory eventsExcessive use of Short-acting ß2-agonists (SABA)

Data analysis plan

Conditional Cox regression will be performed with time to the first event during stable ICS treatment as the outcome variable to estimate HRs with 95% CI. Right censoring will be applied when a change in ICS prescriptions is observed during follow up.Conditional negative binomial regression / logistic regression with the number of events per time periods of one and three years will be performed to estimate RRs / ORs with 95% CI for patients with a continuous follow up time without a change in ICS prescription for these time periods.