Trial Outcomes & Findings for 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 (NCT NCT04011475)
NCT ID: NCT04011475
Last Updated: 2022-06-14
Results Overview
Number of participants with moderate-to-severe acute exacerbation within 1 year after the index date was reported.
COMPLETED
1617 participants
Up to 1 year after the index date (Baseline).
2022-06-14
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
239
|
937
|
441
|
|
Overall Study
Propensity Score Matched Cohort
|
114
|
114
|
114
|
|
Overall Study
COMPLETED
|
239
|
937
|
441
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Tiotropium+Olodaterol (Group A)
n=114 Participants
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.
|
Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B)
n=114 Participants
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.
|
Long-Acting Muscarinic Antagonist (LAMA) (Group C)
n=114 Participants
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.
|
Total
n=342 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
71.1 Years
STANDARD_DEVIATION 9.99 • n=5 Participants
|
71.6 Years
STANDARD_DEVIATION 9.54 • n=7 Participants
|
71.0 Years
STANDARD_DEVIATION 9.37 • n=5 Participants
|
71.3 Years
STANDARD_DEVIATION 9.61 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
318 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
114 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
342 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 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.
Number of participants with moderate-to-severe acute exacerbation within 1 year after the index date was reported.
Outcome measures
| Measure |
Tiotropium+Olodaterol (Group A)
n=114 Participants
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.
|
Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B)
n=114 Participants
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.
|
Long-Acting Muscarinic Antagonist (LAMA) (Group C)
n=114 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Moderate-to-severe Acute Exacerbation
|
20 Participants
|
22 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Tiotropium+Olodaterol (Group A)
n=114 Participants
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.
|
Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B)
n=114 Participants
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.
|
Long-Acting Muscarinic Antagonist (LAMA) (Group C)
n=114 Participants
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.
|
|---|---|---|---|
|
Annualized Rate of Moderate-to-severe Exacerbation
|
0.28 episodes/patient-year
Interval 0.2 to 0.4
|
0.42 episodes/patient-year
Interval 0.32 to 0.56
|
0.10 episodes/patient-year
Interval 0.05 to 0.17
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Tiotropium+Olodaterol (Group A)
n=114 Participants
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.
|
Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B)
n=114 Participants
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.
|
Long-Acting Muscarinic Antagonist (LAMA) (Group C)
n=114 Participants
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.
|
|---|---|---|---|
|
Annualized Rate of Mild Exacerbation
|
0.00 episodes/patient-year
Interval 0.0 to
Since no subject experienced mild acute exacerbation during this period, the upper limit of the rate was divergent to infinity and hence, not available.
|
0.04 episodes/patient-year
Interval 0.02 to 0.11
|
0.04 episodes/patient-year
Interval 0.01 to 0.09
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Tiotropium+Olodaterol (Group A)
n=114 Participants
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.
|
Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B)
n=114 Participants
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.
|
Long-Acting Muscarinic Antagonist (LAMA) (Group C)
n=114 Participants
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.
|
|---|---|---|---|
|
Annualized Rate of Moderate Exacerbation
|
0.19 episodes/patient-year
Interval 0.13 to 0.29
|
0.30 episodes/patient-year
Interval 0.21 to 0.42
|
0.08 episodes/patient-year
Interval 0.04 to 0.15
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Tiotropium+Olodaterol (Group A)
n=114 Participants
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.
|
Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B)
n=114 Participants
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.
|
Long-Acting Muscarinic Antagonist (LAMA) (Group C)
n=114 Participants
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.
|
|---|---|---|---|
|
Annualized Rate of Severe Exacerbation
|
0.09 episodes/patient-year
Interval 0.05 to 0.16
|
0.12 episodes/patient-year
Interval 0.07 to 0.21
|
0.02 episodes/patient-year
Interval 0.0 to 0.07
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Tiotropium+Olodaterol (Group A)
n=114 Participants
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.
|
Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B)
n=114 Participants
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.
|
Long-Acting Muscarinic Antagonist (LAMA) (Group C)
n=114 Participants
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.
|
|---|---|---|---|
|
Incidence of Patients Escalating Therapy (From Single/Dual to Dual/Triple Therapy)
|
10 Participants
|
17 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Tiotropium+Olodaterol (Group A)
n=114 Participants
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.
|
Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B)
n=114 Participants
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.
|
Long-Acting Muscarinic Antagonist (LAMA) (Group C)
n=114 Participants
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.
|
|---|---|---|---|
|
Percentage of Patients Receiving Dual Therapy Escalated to Triple Therapy or LAMA Escalated to Dual Therapy
|
8.8 Percentage of participants
|
14.9 Percentage of participants
|
16.7 Percentage of participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Tiotropium+Olodaterol (Group A)
n=15 Participants
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.
|
Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B)
n=11 Participants
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.
|
Long-Acting Muscarinic Antagonist (LAMA) (Group C)
n=19 Participants
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.
|
|---|---|---|---|
|
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
|
20.0 milliliter
Standard Deviation 240.46
|
-2.1 milliliter
Standard Deviation 176.05
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Tiotropium+Olodaterol (Group A)
n=15 Participants
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.
|
Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B)
n=11 Participants
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.
|
Long-Acting Muscarinic Antagonist (LAMA) (Group C)
n=19 Participants
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.
|
|---|---|---|---|
|
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
|
134.5 milliliter
Standard Deviation 295.38
|
63.7 milliliter
Standard Deviation 375.67
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Tiotropium+Olodaterol (Group A)
n=31 Participants
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.
|
Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B)
n=26 Participants
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.
|
Long-Acting Muscarinic Antagonist (LAMA) (Group C)
n=31 Participants
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.
|
|---|---|---|---|
|
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 5.40
|
1.0 Score on a scale
Standard Deviation 4.51
|
2.4 Score on a scale
Standard Deviation 5.05
|
SECONDARY outcome
Timeframe: At index date (baseline) and at 12 months after index datePopulation: 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.
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.
Outcome measures
| Measure |
Tiotropium+Olodaterol (Group A)
n=28 Participants
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.
|
Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B)
n=23 Participants
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.
|
Long-Acting Muscarinic Antagonist (LAMA) (Group C)
n=21 Participants
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.
|
|---|---|---|---|
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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
|
0.1 Score on a scale
Standard Deviation 0.67
|
0.2 Score on a scale
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: 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.
Percentage of patients using rescue medications within 1 year after index date was reported.
Outcome measures
| Measure |
Tiotropium+Olodaterol (Group A)
n=114 Participants
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.
|
Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B)
n=114 Participants
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.
|
Long-Acting Muscarinic Antagonist (LAMA) (Group C)
n=114 Participants
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.
|
|---|---|---|---|
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Percentage of Patients Using Rescue Medications
|
58.8 Percentage of participants
|
43.9 Percentage of participants
|
45.6 Percentage of participants
|
Adverse Events
Tiotropium+Olodaterol (Group A)
Other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Group B)
Long-Acting Muscarinic Antagonist (LAMA) (Group C)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
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Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER