Effectiveness of Tiotropium + Olodaterol Versus Inhaled Corticosteroids (ICS) + Long-acting β2-agonists (LABA) Among COPD Patients in Taiwan

Study Overview
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Brief Summary
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The real world study aims to assess effectiveness and safety profile between tiotropium/olodaterol (Tio/Olo) and inhaled corticosteroids(ICS) / Long-acting β2-agonists (LABA) in patients with chronic obstructive pulmonary disease (COPD) in Taiwan. The data used in this study will come from the Taiwan National Health Insurance (NHI) claims data between 2014 and 2019.

Official Title
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Effectiveness of Maintenance Treatment With Tiotropium + Olodaterol in Comparison to Inhaled Corticosteroids + Long-acting β2 Agonists in COPD Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: Tiotropium (Tio)
* Drug: Inhaled corticosteroids (ICS)
* Drug: Olodaterol (Olo)
* Drug: Long-acting β2-agonists (LABA)
* Device: Combined Inhaler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least one prescriptions for Tiotropium/Olodaterol (Tio/Olo) combined inhaler or Long-acting ß2 agonist / Inhaled Corticosteroids (LABA/ICS) combined inhaler between 1st January 2014 and 31st December 2019. The first dispensing of either Tio/Olo or LABA/ICS combined inhaler will be defined as the index date; For the main analyses, only fixed dose combination (FDC) inhalers will be included. Aged ≥ 40 years on the index date (in a sensitivity analysis we will only include patients aged ≥ 55 years on the index date); At least one diagnosis of chronic obstructive pulmonary disease (COPD) at any time prior to or on the index date; At least one year of continuous medical and health insurance plan prior to the index date will be required to allow for a look-back period for the covariates and identification of new use of the study drugs; At least one record in the health insurance system database Exclusion Criteria: Any use of Tio/Olo, ICS/LABA, or ICS/LABA/ Long-acting muscarinic antagonists (LAMA) in free or fixed form for one year prior to the index date; Individuals with asthma, allergic rhinitis, lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date (in a sensitivity analysis we will include patients with asthma);

Ages Eligible for Study
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Minimum Age: 40 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 |
| --- | --- |
| Tio/Olo cohort<br>COPD patients included in the NHI database between 2014 and 2019 and who received Tiotropium/olodaterol (Tio/Olo). | Drug: Tiotropium (Tio)<br>* Tiotropium (Tio)<br>Drug: Olodaterol (Olo)<br>* Olodaterol (Olo)<br>Device: Combined Inhaler<br>* Combined Inhaler<br>|
| ICS/LABA cohort<br>COPD patients included in the NHI database between 2014 and 2019 and who received inhaled corticosteroids/ Long-acting ß2-agonists (ICS/LABA). | Drug: Inhaled corticosteroids (ICS)<br>* Inhaled corticosteroids (ICS)<br>Drug: Long-acting β2-agonists (LABA)<br>* Long-acting β2-agonists (LABA)<br>Device: Combined Inhaler<br>* Combined Inhaler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to the first moderate or severe COPD exacerbations after index date |  | Up to 5 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to triple therapy escalation after index date |  | Up to 5 years. | 
| Incidence rate of triple therapy initiation (first event per patient) |  | Up to 5 years. | 
| Time to the first hospitalization for community-acquired pneumonia after entry |  | Up to 5 years. | 
| Annualized rate of prescriptions of rescue medications after the index date | Annualized rate=number of prescriptions/total patient year at risk. Total patient year at risk=number of prescriptions per patient year. | Up to 5 years. | 
| Annualized rate of moderate or severe COPD exacerbation after the index date | Annualized rate=number of moderate or severe COPD exacerbations/total patient year at risk. Total patient year at risk = number of exacerbations per patient year. | Up to 5 years. |