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

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)

Estimated number of subjects

2000
Study design details

Main study objective

To conduct a comparative analysis of patients using Tiotropium in combination with Inhaled Corticosteroids (ICS) versus those that use LABA medication in combination with ICS.

Outcomes

The primary endpoint measure is time to first severe exacerbation, ● Time to first moderate-or-severe exacerbation ● Proportion of patients with exacerbation ● Rate of exacerbation at 6 months and one year ● Proportions of patients with Health care resource utilization (HCRU). HCRU is defined as hospitalizations, emergency

Data analysis plan

Sample attrition at each step of the inclusion-exclusion criteria will be provided. We will develop the breakdown of the distribution of demographic, comorbidity, and baseline measures prior to and after the PSM (unmatched and matched cohorts). Significance of differences will be tested at P<0.05 for the matched cohort. Additionally, we will consider the use of standardized mean differences as noted above, in which SMD <0.1 indicates balance of baseline covariates. The primary endpoint measure is time to first severe exacerbation and severe exacerbation will be defined as a hospitalization or an ER visit with a primary