Trial Outcomes & Findings for Exacerbation Risk in Asthma (NCT NCT05501639)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

1899 participants

Primary outcome timeframe

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

Results posted on

2024-04-01

Participant Flow

The objective of this study was to conduct a retrospective cohort study comparing asthma patients taking tiotropium in combination with inhaled corticosteroids (ICS) versus patients taking long-acting β2-agonists (LABA) medication in combination with ICS.

Propensity score matched (PSM) cohorts of patients between the ICS + tiotropium (tio) and ICS/LABA groups. Patients \>=12 years with least two asthma diagnosis were included and be required to be concurrently on ICS + tio or ICS/LABA.

Participant milestones

Participant milestones
Measure	Tiotropium (Tio) + Inhaled Corticosteroids (ICS) Cohort Patients with at least two asthma diagnosis who were treated concurrently with inhaled corticosteroids (ICS) + tiotropium (specifically tiotropium Respimat 1.25 mcg) between 2014 and 2020. Patients were matched to patients receiving inhaled corticosteroids (ICS) + long-acting β2-agonists (LABA) using a time-conditional propensity score-matched approach.	Long-acting β2-agonists (LABA) + Inhaled Corticosteroids (ICS) Cohort Patients with at least two asthma diagnosis who were treated concurrently with inhaled corticosteroids (ICS) + long-acting β2-agonists (LABA) between 2014 and 2020. Patients were matched to patients receiving inhaled corticosteroids (ICS) + tiotropium (specifically tiotropium Respimat 1.25 mcg) using a time-conditional propensity score-matched approach.
Overall Study STARTED	633	1266
Overall Study COMPLETED	633	1266
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tiotropium (Tio) + Inhaled Corticosteroids (ICS) Cohort n=633 Participants Patients with at least two asthma diagnosis who were treated concurrently with inhaled corticosteroids (ICS) + tiotropium (specifically tiotropium Respimat 1.25 mcg) between 2014 and 2020. Patients were matched to patients receiving inhaled corticosteroids (ICS) + long-acting β2-agonists (LABA) using a time-conditional propensity score-matched approach.	Long-acting β2-agonists (LABA) + Inhaled Corticosteroids (ICS) Cohort n=1266 Participants Patients with at least two asthma diagnosis who were treated concurrently with inhaled corticosteroids (ICS) + long-acting β2-agonists (LABA) between 2014 and 2020. Patients were matched to patients receiving inhaled corticosteroids (ICS) + tiotropium (specifically tiotropium Respimat 1.25 mcg) using a time-conditional propensity score-matched approach.	Total n=1899 Participants Total of all reporting groups
Age, Continuous	45.00 Years STANDARD_DEVIATION 16.43 • n=633 Participants	46.14 Years STANDARD_DEVIATION 16.30 • n=1266 Participants	45.94 Years STANDARD_DEVIATION 16.34 • n=1899 Participants
Sex: Female, Male Female	453 Participants n=633 Participants	903 Participants n=1266 Participants	1356 Participants n=1899 Participants
Sex: Female, Male Male	180 Participants n=633 Participants	363 Participants n=1266 Participants	543 Participants n=1899 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Tiotropium (Tio) + Inhaled Corticosteroids (ICS) Cohort n=4 observations Patients with at least two asthma diagnosis who were treated concurrently with inhaled corticosteroids (ICS) + tiotropium (specifically tiotropium Respimat 1.25 mcg) between 2014 and 2020. Patients were matched to patients receiving inhaled corticosteroids (ICS) + long-acting β2-agonists (LABA) using a time-conditional propensity score-matched approach.	Long-acting β2-agonists (LABA) + Inhaled Corticosteroids (ICS) Cohort n=23 observations Patients with at least two asthma diagnosis who were treated concurrently with inhaled corticosteroids (ICS) + long-acting β2-agonists (LABA) between 2014 and 2020. Patients were matched to patients receiving inhaled corticosteroids (ICS) + tiotropium (specifically tiotropium Respimat 1.25 mcg) using a time-conditional propensity score-matched approach.
Time to First Severe Exacerbation	43.75 Days Standard Deviation 30.50	49.43 Days Standard Deviation 34.07

SECONDARY outcome

Timeframe: 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.

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.