Exacerbation Risk in Asthma

Completed

• Conditions: Asthma
• Interventions: Drug: long-acting β2-agonists (LABA); Drug: tiotropium; Drug: inhaled corticosteroids (ICS)

• Registration Number: NCT05501639
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The purpose of this study is to conduct a comparative analysis of patients using Tiotropium in combination with Inhaled Corticosteroids (ICS) versus those that use long-acting β2-agonists (LABA) medication in combination with ICS.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-14
• Primary Completion: 2021-11-02
• Study Completion: 2021-11-02
• Study First Submitted: 2022-08-12
• Study First Submitted QC: 2022-08-12
• Study First Posted: 2022-08-15
• Results First Submitted: 2022-10-27
• Status Verified: 2023-10
• Results First Submitted QC: 2023-10-02
• Last Update Submitted: 2023-10-02
• Results First Posted: 2024-04-01
• Last Update Posted: 2024-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1899

Inclusion Criteria

• Patients with least two asthma diagnosis
• Patients will be required to be concurrently on inhaled corticosteroids (ICS)+Tiotropium (tio) (specifically Tiotropium Respimat® 1.25 mcg) or ICS/LABA
• Patients will be required to have enrollment for at least 6 months prior to ICS+Tio or ICS/LABA use

Exclusion Criteria

• Patients with least two diagnosis of chronic obstructive pulmonary disease (COPD) at any time during the study period
• Patients less than 12 years of age
• Patients on biologics within 6 months prior to ICS+Tio or ICS/LABA use
• Patients with prior Tio or ICS/LABA use during the 6-month baseline period
• Patients with urinary bladder obstruction, urinary retention, and glaucoma
• After the propensity score matching (PSM) process, unmatched patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
long-acting β2-agonists (LABA) + inhaled corticosteroids (ICS) group	inhaled corticosteroids (ICS)	-
tiotropium + inhaled corticosteroids (ICS) group	inhaled corticosteroids (ICS)	-
long-acting β2-agonists (LABA) + inhaled corticosteroids (ICS) group	long-acting β2-agonists (LABA)	-
tiotropium + inhaled corticosteroids (ICS) group	tiotropium	-

Primary Outcome Measures

Name	Time	Method
Time to First Severe Exacerbation	From index date to first severe exacerbation, up to 1 year.	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.

Secondary Outcome Measures

Name	Time	Method
Rate of Exacerbation at 6 Months and One Year	at 6 months and one year	Rate of exacerbation at 6 months and one year is presented.
Health Care Resource Utilization (HCRU)	From index date to end of follow-up, up to 1 year.	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.
Percentage of Patients With Exacerbation	From index date through first report of exacerbation, up to 1 year.	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 to First Moderate-or-severe Exacerbation	From index date to first moderate-or-severe exacerbation, up to 1 year.	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.
Percentage of Patients With Health Care Resource Utilization (HCRU)	From index date to end of follow-up, up to 1 year.	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.
Percentage of Patients With Use of Rescue Medications	From index date to end of follow-up, up to 1 year.	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.

Trial Locations

Locations (1)

eMax Health; 🇺🇸 White Plains, New York, United States