Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
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
Interventions
Spiolto®
DRUGOther LABA/LAMA
tiotropium/olodaterol, indacaterol/glycopyrronium, vilanterol/umeclidinium
DRUGLAMA
aclidinium bromide, glycopyrronium, tiotropium, umeclidinium
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients who fulfil ALL the following criteria are included. 1. 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 2. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Moderate-to-severe Acute Exacerbation | Up to 1 year after the index date (Baseline). | Number of participants with moderate-to-severe acute exacerbation within 1 year after the index date was reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Annualized Rate of Mild Exacerbation | Up to 1 year after the index date (Baseline). | 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. |
| Annualized Rate of Moderate Exacerbation | Up to 1 year after the index date (Baseline). | 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. |
| Annualized Rate of Severe Exacerbation | Up to 1 year after the index date (Baseline). | 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. |
| Incidence of Patients Escalating Therapy (From Single/Dual to Dual/Triple Therapy) | Up to 1 year after the index date (Baseline). | 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. |
| Percentage of Patients Receiving Dual Therapy Escalated to Triple Therapy or LAMA Escalated to Dual Therapy | Up to 1 year after index date (Baseline). | 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. |
| Annualized Rate of Moderate-to-severe Exacerbation | Up to 1 year after the index date (Baseline). | 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. |
| 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 | At index date (Baseline) and 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. |
| 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 | At index date (Baseline) and 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. |
| 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 | At index date (baseline) and 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. |
| Percentage of Patients Using Rescue Medications | Up to 1 year after index date (Baseline). | Percentage of patients using rescue medications within 1 year after index date was reported. |
| 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 | At index date (Baseline) and 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. |
Countries
Taiwan
Participant flow
Recruitment details
This was a retrospective, multi-center, cohort study to collect the data on 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 investigating the occurrence of COPD exacerbations among such patients.
Pre-assignment details
All subjects were screened for eligibility prior to participation in the trial. Only subjects who strictly met all inclusion and none of the exclusion criteria were included in the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 114 |
| 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. | 114 |
| 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. | 114 |
| Total | 342 |
Baseline characteristics
| Characteristic | Total | Long-Acting Muscarinic Antagonist (LAMA) (Group C) | Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B) | Tiotropium+Olodaterol (Group A) |
|---|---|---|---|---|
| Age, Continuous | 71.3 Years STANDARD_DEVIATION 9.61 | 71.0 Years STANDARD_DEVIATION 9.37 | 71.6 Years STANDARD_DEVIATION 9.54 | 71.1 Years STANDARD_DEVIATION 9.99 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 342 Participants | 114 Participants | 114 Participants | 114 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 24 Participants | 8 Participants | 8 Participants | 8 Participants |
| Sex: Female, Male Male | 318 Participants | 106 Participants | 106 Participants | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 239 | 0 / 937 | 0 / 441 |
| other Total, other adverse events | 0 / 239 | 0 / 937 | 0 / 441 |
| serious Total, serious adverse events | 0 / 239 | 0 / 937 | 0 / 441 |
Outcome results
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.
Time frame: Up to 1 year after the index date (Baseline).
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tiotropium+Olodaterol (Group A) | Number of Participants With Moderate-to-severe Acute Exacerbation | 20 Participants |
| Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B) | Number of Participants With Moderate-to-severe Acute Exacerbation | 22 Participants |
| Long-Acting Muscarinic Antagonist (LAMA) (Group C) | Number of Participants With Moderate-to-severe Acute Exacerbation | 9 Participants |
p-value: 0.0276Log Rank
p-value: 0.666595% CI: [0.47, 1.604]Regression, Cox
p-value: 0.03195% CI: [1.083, 5.221]Regression, Cox
p-value: 0.011695% CI: [1.25, 5.901]Regression, Cox
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.
Time frame: Up to 1 year after the index date (Baseline).
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tiotropium+Olodaterol (Group A) | Annualized Rate of Mild Exacerbation | 0.00 episodes/patient-year |
| Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B) | Annualized Rate of Mild Exacerbation | 0.04 episodes/patient-year |
| Long-Acting Muscarinic Antagonist (LAMA) (Group C) | Annualized Rate of Mild Exacerbation | 0.04 episodes/patient-year |
p-value: 0.739495% CI: [0.34, 4.65]Z-test
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.
Time frame: Up to 1 year after the index date (Baseline).
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tiotropium+Olodaterol (Group A) | Annualized Rate of Moderate Exacerbation | 0.19 episodes/patient-year |
| Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B) | Annualized Rate of Moderate Exacerbation | 0.30 episodes/patient-year |
| Long-Acting Muscarinic Antagonist (LAMA) (Group C) | Annualized Rate of Moderate Exacerbation | 0.08 episodes/patient-year |
p-value: 0.111695% CI: [0.38, 1.11]Z-test
p-value: 0.000495% CI: [1.81, 7.88]Z-test
p-value: 0.023995% CI: [0.19, 0.89]Z-test
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.
Time frame: Up to 1 year after the index date (Baseline).
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tiotropium+Olodaterol (Group A) | Annualized Rate of Moderate-to-severe Exacerbation | 0.28 episodes/patient-year |
| Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B) | Annualized Rate of Moderate-to-severe Exacerbation | 0.42 episodes/patient-year |
| Long-Acting Muscarinic Antagonist (LAMA) (Group C) | Annualized Rate of Moderate-to-severe Exacerbation | 0.10 episodes/patient-year |
p-value: 0.075695% CI: [0.43, 1.04]Z-test
p-value: <0.000195% CI: [2.27, 8.4]Z-test
p-value: 0.002295% CI: [0.17, 0.68]Z-test
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.
Time frame: Up to 1 year after the index date (Baseline).
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tiotropium+Olodaterol (Group A) | Annualized Rate of Severe Exacerbation | 0.09 episodes/patient-year |
| Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B) | Annualized Rate of Severe Exacerbation | 0.12 episodes/patient-year |
| Long-Acting Muscarinic Antagonist (LAMA) (Group C) | Annualized Rate of Severe Exacerbation | 0.02 episodes/patient-year |
p-value: 0.416495% CI: [0.32, 1.61]Z-test
p-value: 0.0195% CI: [1.59, 30.8]Z-test
p-value: 0.037795% CI: [0.04, 0.91]Z-test
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.
Time frame: At index date (Baseline) and at 12 months after index date.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium+Olodaterol (Group A) | 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 | 0.0 Score on a scale | Standard Deviation 5.4 |
| Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B) | 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 | 1.0 Score on a scale | Standard Deviation 4.51 |
| Long-Acting Muscarinic Antagonist (LAMA) (Group C) | 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 | 2.4 Score on a scale | Standard Deviation 5.05 |
p-value: >0.9999Pair t-test
p-value: 0.2516Pair t-test
p-value: 0.0036Pair t-test
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.
Time frame: At index date (baseline) and at 12 months after index date
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium+Olodaterol (Group A) | 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 | 0.1 Score on a scale | Standard Deviation 1.07 |
| Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B) | 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 | 0.1 Score on a scale | Standard Deviation 0.67 |
| Long-Acting Muscarinic Antagonist (LAMA) (Group C) | 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 | 0.2 Score on a scale | Standard Deviation 0.68 |
p-value: 0.6189Wilcoxon (Mann-Whitney)
p-value: 0.7656Wilcoxon (Mann-Whitney)
p-value: 0.3594Wilcoxon (Mann-Whitney)
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.
Time frame: At index date (Baseline) and at 12 months after index date.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium+Olodaterol (Group A) | 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 | -142.0 milliliter | Standard Deviation 197.02 |
| Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B) | 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 | 20.0 milliliter | Standard Deviation 240.46 |
| Long-Acting Muscarinic Antagonist (LAMA) (Group C) | 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 | -2.1 milliliter | Standard Deviation 176.05 |
p-value: 0.0144Pair t-test
p-value: 0.9219Pair t-test
p-value: 0.959Pair t-test
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.
Time frame: At index date (Baseline) and at 12 months after index date.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium+Olodaterol (Group A) | 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 | -74.0 milliliter | Standard Deviation 261.09 |
| Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B) | 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 | 134.5 milliliter | Standard Deviation 295.38 |
| Long-Acting Muscarinic Antagonist (LAMA) (Group C) | 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 | 63.7 milliliter | Standard Deviation 375.67 |
p-value: 0.2909Pair t-test
p-value: 0.1618Pair t-test
p-value: 0.4695Pair t-test
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.
Time frame: Up to 1 year after the index date (Baseline).
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tiotropium+Olodaterol (Group A) | Incidence of Patients Escalating Therapy (From Single/Dual to Dual/Triple Therapy) | 10 Participants |
| Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B) | Incidence of Patients Escalating Therapy (From Single/Dual to Dual/Triple Therapy) | 17 Participants |
| Long-Acting Muscarinic Antagonist (LAMA) (Group C) | Incidence of Patients Escalating Therapy (From Single/Dual to Dual/Triple Therapy) | 19 Participants |
p-value: 0.2035Log Rank
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.
Time frame: Up to 1 year after index date (Baseline).
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tiotropium+Olodaterol (Group A) | Percentage of Patients Receiving Dual Therapy Escalated to Triple Therapy or LAMA Escalated to Dual Therapy | 8.8 Percentage of participants |
| Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B) | Percentage of Patients Receiving Dual Therapy Escalated to Triple Therapy or LAMA Escalated to Dual Therapy | 14.9 Percentage of participants |
| Long-Acting Muscarinic Antagonist (LAMA) (Group C) | Percentage of Patients Receiving Dual Therapy Escalated to Triple Therapy or LAMA Escalated to Dual Therapy | 16.7 Percentage of participants |
p-value: 0.1858Chi-squared
Secondary
Percentage of Patients Using Rescue Medications
Percentage of patients using rescue medications within 1 year after index date was reported.
Time frame: Up to 1 year after index date (Baseline).
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tiotropium+Olodaterol (Group A) | Percentage of Patients Using Rescue Medications | 58.8 Percentage of participants |
| Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B) | Percentage of Patients Using Rescue Medications | 43.9 Percentage of participants |
| Long-Acting Muscarinic Antagonist (LAMA) (Group C) | Percentage of Patients Using Rescue Medications | 45.6 Percentage of participants |
p-value: 0.0483Chi-squared