Exacerbation Risk in Asthma

Severe exacerbation defined as: * Hospitalization with primary diagnosis of asthma or * Emergency room (ER) visit with primary diagnosis of asthma The analysis of this endpoint is based on number of observations (exacerbations). Index date is defined as date when patient entered the cohort. Design 1: A time-varying covariate approach to classify drug exposure time for each comparator drug during follow up was used. For each individual study drug, medication exposure + non-exposure windows during the follow-up time for each medication were identified/defined using date of prescription filled + days' supply listed on prescription claim + 50% additional days.

Time frame: From index date to first severe exacerbation, up to 1 year.

Population: The main analysis was on matched cohorts of patients between the ICS + tio and ICS/LABA cohorts using a 1:2 propensity score matching (PSM) approach. PSM resulted in a match of each ICS + tio patient to 2 ICS/LABA patients. Values were presented for matched populations. Only patients with severe exacerbation were included in this analysis.

Health care resource utilization (HCRU) are presented including frequency of hospitalizations, ER visits, outpatient visits. Outpatient visits are defined as clinic, hospital, or other medical institution (e.g. public health, etc.) visit as an outpatient. Mean and standard deviations of: * Number of hospitalisations per person per month * Number of asthma-related hospitalisations per person per month * Number of ER visits per person per month * Number of asthma-related ER visits per person per month * Number of outpatient visits per person per month * Number of asthma-related outpatient visits per person per month are presented.

Time frame: From index date to end of follow-up, up to 1 year.

Population: The main analysis was on matched cohorts of patients between the ICS + tio and ICS/LABA cohorts using a 1:2 propensity score matching (PSM) approach. PSM resulted in a match of each ICS + tio patient to 2 ICS/LABA patients. Values were presented for matched populations.

Percentage of patients with exacerbation is presented. Design 2: The second analysis, included on an ad-hoc basis was using an intent-to-treat (ITT) design where patients were assigned to the cohort, they were part of at the index date.

Time frame: From index date through first report of exacerbation, up to 1 year.

Population: The main analysis was on matched cohorts of patients between the ICS + tio and ICS/LABA cohorts using a 1:2 propensity score matching (PSM) approach. PSM resulted in a match of each ICS + tio patient to 2 ICS/LABA patients. Values were presented for matched populations.

Percentage of patients with Health care resource utilization (HCRU) is presented and is defined as hospitalizations, emergency room (ER) visits, and outpatient visits during follow-up, all-cause and asthma related.

Time frame: From index date to end of follow-up, up to 1 year.

Population: The main analysis was on matched cohorts of patients between the ICS + tio and ICS/LABA cohorts using a 1:2 propensity score matching (PSM) approach. PSM resulted in a match of each ICS + tio patient to 2 ICS/LABA patients. Values were presented for matched populations.

Percentage of patients with use of rescue medications is presented. Use of rescue medication is defined as patients with one or more short-acting β2-agonists (SABA) claims during the follow-up period.

Time frame: From index date to end of follow-up, up to 1 year.

Population: The main analysis was on matched cohorts of patients between the ICS + tio and ICS/LABA cohorts using a 1:2 propensity score matching (PSM) approach. PSM resulted in a match of each ICS + tio patient to 2 ICS/LABA patients. Values were presented for matched populations.

Rate of exacerbation at 6 months and one year is presented.

Time frame: at 6 months and one year

Population: The main analysis was on matched cohorts of patients between the ICS + tio and ICS/LABA cohorts using a 1:2 propensity score matching (PSM) approach. PSM resulted in a match of each ICS + tio patient to 2 ICS/LABA patients. Values were presented for matched populations.

Severe exacerbation defined as: * Hospitalization with primary diagnosis of asthma or * Emergency room (ER) visit with primary diagnosis of asthma The analysis of this endpoint is based on number of observations (exacerbations). Index date is defined as date when patient entered the cohort. Design 1: A time-varying covariate approach to classify drug exposure time for each comparator drug during follow up was used. For each individual study drug, medication exposure + non-exposure windows during the follow-up time for each medication were identified/defined using date of prescription filled + days' supply listed on prescription claim + 50% additional days.

Time frame: From index date to first moderate-or-severe exacerbation, up to 1 year.

Population: The main analysis was on matched cohorts of patients between the ICS + tio and ICS/LABA cohorts using a 1:2 propensity score matching (PSM) approach. PSM resulted in a match of each ICS + tio patient to 2 ICS/LABA patients. Values were presented for matched populations. Only patients with moderate-to-severe exacerbation were included in this analysis.