| Primary | 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. | Propensity score matched cohort: All eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with tiotropium + olodaterol, other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Fixed-dose Combination (FDC) or free combo) or LAMA treatment for 3 months at least prior to 30 June 2018, and matching via propensity score to balance the baseline characteristics between the study groups. | Posted | | Count of Participants | | Participants | | Up to 1 year after the index date (Baseline). | | | | ID | Title | Description |
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| OG000 | Tiotropium+Olodaterol (Group A) | Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with tiotropium + olodaterol for 3 months at least prior to 30 June 2018 were included in this group. | | OG001 | Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B) | Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (fixed-dose combinations (FDC)/free combos) for 3 months at least prior to 30 June 2018 were included in this group. | | OG002 | Long-Acting Muscarinic Antagonist (LAMA) (Group C) | Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with other Long-Acting Muscarinic Antagonist (LAMA) for 3 months at least prior to 30 June 2018 were included in this group. |
| | | Title | Denominators | Categories |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Log Rank | | 0.0276 | | | | | | | | | | | | | | Other | | | | | Regression, Cox | | 0.6665 | | Hazard Ratio (HR) |
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| Secondary | 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. | Propensity score matched cohort: All eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with tiotropium + olodaterol, other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Fixed-dose Combination (FDC) or free combo) or LAMA treatment for 3 months at least prior to 30 June 2018, and matching via propensity score to balance the baseline characteristics between the study groups. | Posted | | Number | 95% Confidence Interval | episodes/patient-year | | Up to 1 year after the index date (Baseline). | | | | ID | Title | Description |
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| OG000 | Tiotropium+Olodaterol (Group A) | Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with tiotropium + olodaterol for 3 months at least prior to 30 June 2018 were included in this group. | | OG001 | Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B) | Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (fixed-dose combinations (FDC)/free combos) for 3 months at least prior to 30 June 2018 were included in this group. |
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| Secondary | 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. | Propensity score matched cohort: All eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with tiotropium + olodaterol, other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Fixed-dose Combination (FDC) or free combo) or LAMA treatment for 3 months at least prior to 30 June 2018, and matching via propensity score to balance the baseline characteristics between the study groups. | Posted | | Number | 95% Confidence Interval | episodes/patient-year | | Up to 1 year after the index date (Baseline). | | | | ID | Title | Description |
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| OG000 | Tiotropium+Olodaterol (Group A) | Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with tiotropium + olodaterol for 3 months at least prior to 30 June 2018 were included in this group. | | OG001 | Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B) | Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (fixed-dose combinations (FDC)/free combos) for 3 months at least prior to 30 June 2018 were included in this group. |
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| Secondary | 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. | Propensity score matched cohort: All eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with tiotropium + olodaterol, other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Fixed-dose Combination (FDC) or free combo) or LAMA treatment for 3 months at least prior to 30 June 2018, and matching via propensity score to balance the baseline characteristics between the study groups. | Posted | | Number | 95% Confidence Interval | episodes/patient-year | | Up to 1 year after the index date (Baseline). | | | | ID | Title | Description |
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| OG000 | Tiotropium+Olodaterol (Group A) | Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with tiotropium + olodaterol for 3 months at least prior to 30 June 2018 were included in this group. | | OG001 | Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B) | Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (fixed-dose combinations (FDC)/free combos) for 3 months at least prior to 30 June 2018 were included in this group. |
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| Secondary | 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. | Propensity score matched cohort: All eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with tiotropium + olodaterol, other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Fixed-dose Combination (FDC) or free combo) or LAMA treatment for 3 months at least prior to 30 June 2018, and matching via propensity score to balance the baseline characteristics between the study groups. | Posted | | Number | 95% Confidence Interval | episodes/patient-year | | Up to 1 year after the index date (Baseline). | | | | ID | Title | Description |
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| OG000 | Tiotropium+Olodaterol (Group A) | Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with tiotropium + olodaterol for 3 months at least prior to 30 June 2018 were included in this group. | | OG001 | Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B) | Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (fixed-dose combinations (FDC)/free combos) for 3 months at least prior to 30 June 2018 were included in this group. |
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| Secondary | 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. | Propensity score matched cohort: All eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with tiotropium + olodaterol, other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Fixed-dose Combination (FDC) or free combo) or LAMA treatment for 3 months at least prior to 30 June 2018, and matching via propensity score to balance the baseline characteristics between the study groups. | Posted | | Count of Participants | | Participants | | Up to 1 year after the index date (Baseline). | | | | ID | Title | Description |
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| OG000 | Tiotropium+Olodaterol (Group A) | Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with tiotropium + olodaterol for 3 months at least prior to 30 June 2018 were included in this group. | | OG001 | Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B) | Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (fixed-dose combinations (FDC)/free combos) for 3 months at least prior to 30 June 2018 were included in this group. |
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| Secondary | 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. | Propensity score matched cohort: All eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with tiotropium + olodaterol, other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Fixed-dose Combination (FDC) or free combo) or LAMA treatment for 3 months at least prior to 30 June 2018, and matching via propensity score to balance the baseline characteristics between the study groups. | Posted | | Number | | Percentage of participants | | Up to 1 year after index date (Baseline). | | | | ID | Title | Description |
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| OG000 | Tiotropium+Olodaterol (Group A) | Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with tiotropium + olodaterol for 3 months at least prior to 30 June 2018 were included in this group. | | OG001 | Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B) | Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (fixed-dose combinations (FDC)/free combos) for 3 months at least prior to 30 June 2018 were included in this group. |
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| Secondary | 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. | Propensity score (PS) matched cohort: All eligible Chronic Obstructive Pulmonary Disease patients in Taiwan who were administered with tiotropium + olodaterol, other Long-Acting Beta-Agonist +Long-Acting Muscarinic Antagonist (LAMA) (Fixed-dose Combination or free combo) or LAMA treatment for 3 months at least prior to 30 June 2018, and matching via PS to balance the baseline characteristics between the study groups. Only patients with non-missing endpoint results were included in the analysis. | Posted | | Mean | Standard Deviation | milliliter | | At index date (Baseline) and at 12 months after index date. | | | | ID | Title | Description |
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| OG000 | Tiotropium+Olodaterol (Group A) | Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with tiotropium + olodaterol for 3 months at least prior to 30 June 2018 were included in this group. |
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| Secondary | 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. | Propensity score (PS) matched cohort: All eligible Chronic Obstructive Pulmonary Disease patients in Taiwan who were administered with tiotropium + olodaterol, other Long-Acting Beta-Agonist +Long-Acting Muscarinic Antagonist (LAMA) (Fixed-dose Combination or free combo) or LAMA treatment for 3 months at least prior to 30 June 2018, and matching via PS to balance the baseline characteristics between the study groups. Only patients with non-missing endpoint results were included in the analysis. | Posted | | Mean | Standard Deviation | milliliter | | At index date (Baseline) and at 12 months after index date. | | | | ID | Title | Description |
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| OG000 | Tiotropium+Olodaterol (Group A) | Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with tiotropium + olodaterol for 3 months at least prior to 30 June 2018 were included in this group. | |
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| Secondary | 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. | Propensity score (PS) matched cohort: All eligible Chronic Obstructive Pulmonary Disease patients in Taiwan who were administered with tiotropium + olodaterol, other Long-Acting Beta-Agonist +Long-Acting Muscarinic Antagonist (LAMA) (Fixed-dose Combination or free combo) or LAMA treatment for 3 months at least prior to 30 June 2018, and matching via PS to balance the baseline characteristics between the study groups. Only patients with non-missing endpoint results were included in the analysis. | Posted | | Mean | Standard Deviation | Score on a scale | | At index date (Baseline) and at 12 months after index date. | | | | ID | Title | Description |
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| OG000 | Tiotropium+Olodaterol (Group A) | Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with tiotropium + olodaterol for 3 months at least prior to 30 June 2018 were included in this group. |
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| Secondary | 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. | Propensity score (PS) matched cohort: All eligible Chronic Obstructive Pulmonary Disease patients in Taiwan who were administered with tiotropium + olodaterol, other Long-Acting Beta-Agonist +Long-Acting Muscarinic Antagonist (LAMA) (Fixed-dose Combination or free combo) or LAMA treatment for 3 months at least prior to 30 June 2018, and matching via PS to balance the baseline characteristics between the study groups. Only patients with non-missing endpoint results were included in the analysis. | Posted | | Mean | Standard Deviation | Score on a scale | | At index date (baseline) and at 12 months after index date | | | | ID | Title | Description |
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| OG000 | Tiotropium+Olodaterol (Group A) | Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with tiotropium + olodaterol for 3 months at least prior to 30 June 2018 were included in this group. |
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| Secondary | Percentage of Patients Using Rescue Medications | Percentage of patients using rescue medications within 1 year after index date was reported. | Propensity score matched cohort: All eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with tiotropium + olodaterol, other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Fixed-dose Combination (FDC) or free combo) or LAMA treatment for 3 months at least prior to 30 June 2018, and matching via propensity score to balance the baseline characteristics between the study groups. | Posted | | Number | | Percentage of participants | | Up to 1 year after index date (Baseline). | | | | ID | Title | Description |
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| OG000 | Tiotropium+Olodaterol (Group A) | Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with tiotropium + olodaterol for 3 months at least prior to 30 June 2018 were included in this group. | | OG001 | Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B) | Eligible Chronic Obstructive Pulmonary Disease (COPD) patients in Taiwan who were administered with other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (fixed-dose combinations (FDC)/free combos) for 3 months at least prior to 30 June 2018 were included in this group. | | OG002 |
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