Exacerbation Risk in Asthma

Study Overview
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Brief Summary
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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.

Official Title
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Exacerbation Risk and Health Care Resource Use Among Patients With Asthma Using ICS+Tiotropium Versus ICS/LABA

Conditions
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Asthma

Intervention / Treatment
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* Drug: tiotropium
* Drug: long-acting β2-agonists (LABA)
* Drug: inhaled corticosteroids (ICS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| tiotropium + inhaled corticosteroids (ICS) group<br> | Drug: tiotropium<br>* tiotropium<br>Drug: inhaled corticosteroids (ICS)<br>* inhaled corticosteroids (ICS)<br>|
| long-acting β2-agonists (LABA) + inhaled corticosteroids (ICS) group<br> | Drug: long-acting β2-agonists (LABA)<br>* long-acting β2-agonists (LABA)<br>Drug: inhaled corticosteroids (ICS)<br>* inhaled corticosteroids (ICS)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first severe exacerbation | Severe exacerbation is defined as: A hospitalization with a primary diagnosis of asthma or An emergency room (ER) visit with a primary diagnosis of asthma | Up to 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first moderate-or-severe exacerbation | Severe exacerbation is defined as: Any systemic corticosteroid use or A hospitalization with a primary diagnosis of asthma or An ER visit with a primary diagnosis of asthma | Up to 6 years | 
| Proportion of patients with exacerbation |  | Up to 6 years | 
| Rate of exacerbation at 6 months and one year |  | Up to one year | 
| Proportions of patients with Health care resource utilization (HCRU) | defined as hospitalizations, emergency room (ER) visits, and outpatient visits during follow-up, all-cause and asthma related | Up to 6 years | 
| Mean monthly HCRU | including frequency of hospitalizations, ER visits, outpatient visits | Up to 6 years | 
| Proportion of patients with use of rescue medications | defined as patients with one or more short-acting β2-agonists (SABA) claims during the follow-up period | Up to 6 years |