Study type

Study type

Non-interventional study

Scope of the study

Disease epidemiology
Non-interventional study

Non-interventional study design

Cohort
Cross-sectional
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)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

11000
Study design details

Main study objective

To understand the pattern of comorbidities in adults with severe asthma and investigate their association with asthma-related outcomes

Outcomes

The prevalence of comorbidities will be described in patients with severe asthma. The impact of T2-related comorbidities on response to biologics will be assessed

Data analysis plan

1. Overall prevalence of history of individual comorbidities (ever/never) will be calculated over the timeframe covered by ISAR. In addition, the number of comorbidities will be calculated for each patient and prevalence of comorbidity counts computed (eg, prevalence of 0, 1, 2, and 3+ comorbid conditions). 2.The prevalence estimates will be compared between demographic and clinical features: - through chi-square tests for categorical variables, - through t-test comparisons or non-parametric Wilcoxon tests for continuous variables. 3.For patients initiating biologics, we will compare patients with at least one T2 comorbidity or without T2 comorbidity, and by individual T2 comorbidity types, with respect to four asthma-related outcomes measured the period 24 weeks to 1 year following the biologic initiation:exacerbation rate (risk ratios), asthma control (difference of proportions), lung function (difference of means or medians), cumulative OCS dose (difference of means or medians)