The effectiveness of Tiotropium Add-on therapy using a Real-world cohort of patients with Asthma (Tiotropium therapy in Asthma)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Tiotropium Bromide
• Study drug International non-proprietary name (INN) or common name:
  TIOTROPIUM
• Medical condition to be studied:
  Asthma

Population studied

• Age groups:
  Adolescents (12 to < 18 years)
• Estimated number of subjects:
  6300

Study design details

• Main study objective:
  To evaluate the effectiveness of add on therapy with Tiotropium Respimat® compared to increasing the dose of ICS in patients with a diagnosis of Asthma and on ICS/LABA therapy
• Outcomes:
  The primary outcome measure is time to first exacerbation per person, Secondary endpoints will include,Rate of exacerbation,Health Care Resource Utilization (HCRU)HCRU is defined as frequency of hospitalizations, ER visits, and outpatient visits during follow-up, all-cause and asthma related, and the associated costs (medical and pharmacy).
• Data analysis plan:
  For the primary endpoints analysis, we will calculate the time to first exacerbation per patient and compare it between the two groups (Tio vs. NonTio). For secondary endpoint analyses we will compare the rate of exacerbation, proportion of patients with exacerbations after 6 months and one year (based on Kaplan Meier estimates), HCRU and average cost during follow-up and compare them between the two groups (Tio vs. NonTio). We will calculate time to first biologic use during follow-up. The primary outcome of the study will be analyzed using Cox proportional hazard modelling. The secondary outcome of rate of exacerbation per patient will be analyzed using negative binomial regression.