Benefits of high dose ICS in patients with asthma and high blood eosinophil counts

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.