Safety of Tiotropium + Olodaterol in Chronic Obstructive Pulmonary Disease (COPD) Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data

Study Overview
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Brief Summary
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The aim of this real world study is to assess the safety profile of tiotropium/olodaterol (Tio/Olo).

Official Title
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Safety Profile of Tiotropium + Olodaterol Used as Maintenance Treatment 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+Olodaterol
* Device: Spiolto Respimat
* Drug: Long-acting muscarinic antagonists (LAMAs)
* Drug: Long-acting β2-agonists (LABAs)


Participation Criteria
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Eligibility Criteria
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Patients treated with Tio+Olo: Inclusion criteria: At least one prescription for Tio+Olo (fixed dose combination (FDC) or free combination) as a new initiation between 1st January 2014 and 31st December 2019. Aged ≥ 40 years on the index date. At least one diagnosis of 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 in free or fixed form within 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. Patients using other Long-acting β2-agonists/Long-acting muscarinic antagonists (LAMA/LABAs): Inclusion criteria: At least one prescription for LAMA+LABA (FDC or free combination) other than Tio/Olo as a new initiation between 1st January 2014 and 31st December 2019. Aged ≥ 40 years on the index date. At least one diagnosis of 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 LAMA+LABA 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.

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 |
| --- | --- |
| COPD patients treated with tiotropium and olodaterol (Tio+Olo)<br> | Drug: Tiotropium+Olodaterol<br>* Tiotropium+Olodaterol<br>Device: Spiolto Respimat<br>* Spiolto Respimat Inhaler device<br>|
| COPD patients using other Long-acting muscarinic antagonists/Long-acting β2-agonists (LAMA/LABAs)<br> | Drug: Long-acting muscarinic antagonists (LAMAs)<br>* Long-acting muscarinic antagonists (LAMAs)<br>Drug: Long-acting β2-agonists (LABAs)<br>* Long-acting β2-agonists (LABAs)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of adverse events in patients with COPD treated with Tio+Olo |  | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline characteristics of patients who initiated Tio+Olo or other LAMA/LABA |  | up to 5 years |