A Study in Taiwan Based on Medical Records That Looks at the Occurrence of Flare-ups in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Started LABA/LAMA or LAMA Treatment

Study Overview
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Brief Summary
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Study to collect the data on Chronic Obstructive Pulmonary Disease (COPD) patients who were administered with Long-Acting Beta-Agonist/ Long-Acting Muscarinic Antagonist (LABA/LAMA) (Fixed-dose Combination (FDC) or free combo) or LAMA treatment

Official Title
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Taiwan Outcomes and Real-world Treatment Options for Chronic Obstructive Pulmonary Disease

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: Tiotropium + Olodaterol
* Drug: Other LABA/LAMA
* Drug: LAMA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who fulfil ALL the following criteria are included. Patients who diagnosed with COPD who were prescribed with LABA/LABA (FDC or free combo) as a new initiation or switching from other therapy (i.e., single/dual/triple), or newly receiving LAMA treatment for 3 months at least prior to 30 June 2018 Male or female patients ≥ 40 years of age Exclusion Criteria: 1. Patients who meet the following criterion are not included. Patients with documented diagnosis of bronchial asthma, asthma-COPD overlap syndrome (ACOS), bronchiectasis, cystic fibrosis, or lung cancer

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 |
| --- | --- |
| Subjects with Tiotropium and Olodaterol<br> | Drug: Tiotropium + Olodaterol<br>* Spiolto®<br>|
| Subjects treated with other LABA/LAMA therapy<br> | Drug: Other LABA/LAMA<br>* tiotropium/olodaterol, indacaterol/glycopyrronium, vilanterol/umeclidinium<br>|
| Subjects treated with LAMA therapy<br> | Drug: LAMA<br>* aclidinium bromide, glycopyrronium, tiotropium, umeclidinium<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Moderate-to-severe Acute Exacerbation | Number of participants with moderate-to-severe acute exacerbation within 1 year after the index date was reported. | Up to 1 year after the index date (Baseline). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annualized Rate of Moderate-to-severe Exacerbation | The annualized rate of moderate-to-severe exacerbation was calculated as: total number of episodes of moderate-to-severe exacerbation of all participants divided by the sum of follow-up period [years] of all participants. The corresponding 95% confidence interval was from Poisson regression. | Up to 1 year after the index date (Baseline). | 
| Annualized Rate of Mild Exacerbation | The annualized rate of mild exacerbation was calculated as: total number of episodes of mild exacerbation of all participants divided by the sum of follow-up period [years] of all participants. The corresponding 95% confidence interval was from Poisson regression. | Up to 1 year after the index date (Baseline). | 
| Annualized Rate of Moderate Exacerbation | The annualized rate of moderate exacerbation was calculated as: total number of episodes of moderate exacerbation of all participants divided by the sum of follow-up period [years] of all participants. The corresponding 95% confidence interval was from Poisson regression. | Up to 1 year after the index date (Baseline). | 
| Annualized Rate of Severe Exacerbation | The annualized rate of severe exacerbation was calculated as: total number of episodes of severe exacerbation of all participants divided by the sum of follow-up period [years] of all participants. The corresponding 95% confidence interval was from Poisson regression. | Up to 1 year after the index date (Baseline). | 
| Incidence of Patients Escalating Therapy (From Single/Dual to Dual/Triple Therapy) | Incidence of patients escalating therapy, from single/dual to dual/triple therapy such as receiving Long-Acting Muscarinic Antagonist (LAMA) escalated to dual therapy or receiving LABA+LAMA (Tiotropium+Olodaterol) escalated to triple therapy(LABA+LAMA+inhaled corticosteroids (ICS)), within 1 year after the index date was reported. | Up to 1 year after the index date (Baseline). | 
| Percentage of Patients Receiving Dual Therapy Escalated to Triple Therapy or LAMA Escalated to Dual Therapy | Percentage of patients receiving dual therapy (Tiotropium+Olodaterol or other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) therapy) escalated to triple therapy (LABA+LAMA + inhaled corticosteroids (ICS)) or LAMA escalated to dual therapy (LABA + LAMA) was reported. | Up to 1 year after index date (Baseline). | 
| Change From Baseline in Pulmonary Function After LABA+LAMA or LAMA Initiation Evaluating by Post-bronchodilator Forced Expiratory Volume in One Second (Post-FEV1) at 12 Months After Index Date | Change from baseline in pulmonary function after Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Tiotropium+Olodaterol or other LABA+LAMA therapy) or LAMA initiation evaluating by post-bronchodilatorForced Expiratory Volume in one second (Post-FEV1) at 12 months after index date was reported. Spirometry was the most common tool to evaluate the lung function of patients with respiratory disease. Among the results of spirometry, post-bronchodilator Forced Expiratory Volume in one second was used for assisting in the diagnosis, determining disease severity, and following up the prognosis. | At index date (Baseline) and at 12 months after index date. | 
| Change From Baseline in Pulmonary Function After LABA+LAMA or LAMA Initiation Evaluating by Post-bronchodilator Forced Volume Vital Capacity (Post-FVC) at 12 Months After Index Date | Change from baseline in pulmonary function after Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Tiotropium+Olodaterol or other LABA+LAMA therapy) or LAMA initiation evaluating by post-bronchodilator Forced Volume Vital Capacity (Post-FVC) at 12 months after index date was reported. Spirometry was the most common tool to evaluate the lung function of patients with respiratory disease. Among the results of spirometry, post-bronchodilator Forced Volume Vital Capacity was used for assisting in the diagnosis, determining disease severity, and following up the prognosis. | At index date (Baseline) and at 12 months after index date. | 
| Change From Baseline in Pulmonary Function After LABA+LAMA or LAMA Initiation Evaluating by COPD Assessment Test (CAT) Score at 12 Months After Index Date | Change from baseline in pulmonary function after Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Tiotropium+Olodaterol or other LABA+LAMA therapy) or LAMA initiation evaluating by Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) score at 12 months after index date was reported. The COPD assessment test (CAT) was a simple, 8-item, health status instrument which provided a simple method for assessing the impact of COPD on the patient's health and the quality of life. Each item was on a 6-point scale: 0 (no impact) to 5 (maximum impact). The CAT score ranging from 0 (better health status) to 40 (worse health status) was calculated by summing the points for each item. A decrease in CAT score represents an improvement in health status, whereas an increase in CAT score represents a worsening in health status. | At index date (Baseline) and at 12 months after index date. | 
| Change From Baseline in Pulmonary Function After LABA+LAMA or LAMA Initiation Evaluating by Modified Medical Research Council Dyspnea Scale (mMRC) at 12 Months After Index Date | Change from baseline in pulmonary function after Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Tiotropium+Olodaterol or other LABA+LAMA therapy) or LAMA initiation evaluating by modified Medical Research Council dyspnea scale (mMRC) at 12 months after index date is reported. Modified Medical Research Council dyspnea scale (mMRC) is a 5 points scale measuring the severity of dyspnea of patients. The scale ranges from 0 (better outcome) to 4 (worse outcome). The higher the scale value, the more severe the dyspnea is. If mMRC scale of the patient was > 2, it means the patient may suffer from dyspnea. | At index date (baseline) and at 12 months after index date | 
| Percentage of Patients Using Rescue Medications | Percentage of patients using rescue medications within 1 year after index date was reported. | Up to 1 year after index date (Baseline). |