Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
This study aims to evaluate the time to escalation to triple therapy among the Japanese Chronic obstructive pulmonary disease (COPD) patients newly initiating therapy with a combination of Olodaterol and Tiotropium (herein referred to as Tio/Olo) using real world data.
Interventions
Soft Mist Inhaler product
DRUGTiotropium
Soft Mist Inhaler product
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
The study cohort will include all patients who initiate Tiotropium/ Olodaterol (Tio/Olo) or Tiotropium (Tio) during the patient selection period.
Exclusion criteria
The following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Triple Therapy Initiation | From index date (cohort entry date) until first occurence of event, up to 42 months. | Time to triple therapy initiation (first event per patient) defined as any fixed dose combination of Long-acting muscarinic antagonists (LAMA) / Long-acting beta agonist (LABA) / Inhaled Corticosteroid (ICS) or any concurrent use for 30 consecutive days of the following: * any LAMA/LABA fixed dose combination + any ICS single formulation * any LAMA single formulation + any LABA/ICS fixed dose combination * any LAMA single formulation + any LABA single formulation + any ICS single formulation. Patients will be censored if they had an occurrence of any of the following: outcome (initiation of triple therapy), death, or end of data. The analysis will use an intention-to-treat censoring approach, which does not account for treatment change. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | From index date until first occurence of event, up to 42 months. | Time to First Moderate or Severe COPD Exacerbation. Moderate exacerbation is defined as an outpatient visit with a diagnosed code for COPD in any field + a prescription for an oral corticosteroid or an antibiotic for respiratory infections. Severe exacerbations will be defined as a hospitalization with a primary diagnosis for COPD. Patients will be censored if they had an occurrence of any of the following: outcome (initiation of triple therapy), death, or end of data. The analysis will use an intention-to-treat censoring approach, which does not account for treatment change. |
| Number of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | From index date until first occurence of event, up to 42 months. | Number of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations. Moderate exacerbation is defined as an outpatient visit with a diagnosed code for COPD in any field + a prescription for an oral corticosteroid or an antibiotic for respiratory infections. Severe exacerbations will be defined as a hospitalization with a primary diagnosis for COPD. Patients will be censored if they had an occurrence of any of the following: outcome (initiation of triple therapy), death, or end of data. The analysis will use an intention-to-treat censoring approach, which does not account for treatment change. |
Countries
Japan
Participant flow
Recruitment details
A new-user, active comparator retrospective comparative cohort study using a Japanese electronic healthcare research database.The study aims to test early intervention effectiveness of tiotropium/olodaterol compared to tiotropium in patients with chronic obstructive pulmonary disease (COPD).
Pre-assignment details
Only subjects that met all inclusion and none of the exclusion criteria were included in the study. The enrolled patients were matched into 2 (not mutually exclusive) cohorts: 1) basic propensity score (PS) cohort, 2) high dimensional propensity score (hdPS) cohort.
Participants by arm
| Arm | Count |
|---|---|
| Tiotropium/Olodaterol (Spiolto®) All patients with chronic obstructive pulmonary disease (COPD), included in the Japanese electronic healthcare research database (MDV Japan), who initiated Tiotropium/Olodaterol (Tio/Olo) during the patient selection period (September 2015 to December 2018). Patients were followed up a maximum of 360 days or until end of study period (March 2019, end of available data). | 1,436 |
| Tiotropium (Spiriva®) All patients with chronic obstructive pulmonary disease (COPD), included in the Japanese electronic healthcare research database (MDV Japan), who initiated Tiotropium during the patient selection period (September 2015 to December 2018). Patients were followed up a maximum of 360 days or until end of study period (March 2019, end of available data). | 5,352 |
| Total | 6,788 |
Baseline characteristics
| Characteristic | Tiotropium/Olodaterol (Spiolto®) | Tiotropium (Spiriva®) | Total |
|---|---|---|---|
| Age, Continuous | 75.16 Years STANDARD_DEVIATION 8.41 | 75.56 Years STANDARD_DEVIATION 8.9 | 75.48 Years STANDARD_DEVIATION 8.8 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 163 Participants | 779 Participants | 942 Participants |
| Sex: Female, Male Male | 1273 Participants | 4573 Participants | 5846 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Time to Triple Therapy Initiation
Time to triple therapy initiation (first event per patient) defined as any fixed dose combination of Long-acting muscarinic antagonists (LAMA) / Long-acting beta agonist (LABA) / Inhaled Corticosteroid (ICS) or any concurrent use for 30 consecutive days of the following: * any LAMA/LABA fixed dose combination + any ICS single formulation * any LAMA single formulation + any LABA/ICS fixed dose combination * any LAMA single formulation + any LABA single formulation + any ICS single formulation. Patients will be censored if they had an occurrence of any of the following: outcome (initiation of triple therapy), death, or end of data. The analysis will use an intention-to-treat censoring approach, which does not account for treatment change.
Time frame: From index date (cohort entry date) until first occurence of event, up to 42 months.
Population: All patients included on the Japanese electronic, record based health care database (MDV) between September 2015 and December 2019 using either a combination of tiotropium/olodaterol or tiotropium alone - High dimensional propensity score (hdPS) matched cohort.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium/Olodaterol (Spiolto®) | Time to Triple Therapy Initiation | 195.0 Days | Standard Deviation 123.2 |
| Tiotropium (Spiriva®) | Time to Triple Therapy Initiation | 89.5 Days | Standard Deviation 112.3 |
95% CI: [0.32, 2.46]
Secondary
Number of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Number of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations. Moderate exacerbation is defined as an outpatient visit with a diagnosed code for COPD in any field + a prescription for an oral corticosteroid or an antibiotic for respiratory infections. Severe exacerbations will be defined as a hospitalization with a primary diagnosis for COPD. Patients will be censored if they had an occurrence of any of the following: outcome (initiation of triple therapy), death, or end of data. The analysis will use an intention-to-treat censoring approach, which does not account for treatment change.
Time frame: From index date until first occurence of event, up to 42 months.
Population: All patients included on the Japanese electronic, record based health care database (MDV) between September 2015 and December 2019 using either a combination of tiotropium/olodaterol or tiotropium alone - Unmatched cohort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tiotropium/Olodaterol (Spiolto®) | Number of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | Moderate or Severe Exacerbations | 0.08 Number of Exacerbations | Standard Deviation 0.33 |
| Tiotropium/Olodaterol (Spiolto®) | Number of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | Moderate Exacerbations | 0.04 Number of Exacerbations | Standard Deviation 0.22 |
| Tiotropium/Olodaterol (Spiolto®) | Number of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | Severe Exacerbations | 0.05 Number of Exacerbations | Standard Deviation 0.24 |
| Tiotropium (Spiriva®) | Number of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | Moderate or Severe Exacerbations | 0.08 Number of Exacerbations | Standard Deviation 0.34 |
| Tiotropium (Spiriva®) | Number of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | Moderate Exacerbations | 0.04 Number of Exacerbations | Standard Deviation 0.22 |
| Tiotropium (Spiriva®) | Number of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | Severe Exacerbations | 0.05 Number of Exacerbations | Standard Deviation 0.27 |
Secondary
Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Time to First Moderate or Severe COPD Exacerbation. Moderate exacerbation is defined as an outpatient visit with a diagnosed code for COPD in any field + a prescription for an oral corticosteroid or an antibiotic for respiratory infections. Severe exacerbations will be defined as a hospitalization with a primary diagnosis for COPD. Patients will be censored if they had an occurrence of any of the following: outcome (initiation of triple therapy), death, or end of data. The analysis will use an intention-to-treat censoring approach, which does not account for treatment change.
Time frame: From index date until first occurence of event, up to 42 months.
Population: All patients included on the Japanese electronic, record based health care database (MDV) between September 2015 and December 2019 using either a combination of tiotropium/olodaterol or tiotropium alone - High dimensional propensity score (hdPS) matched cohort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tiotropium/Olodaterol (Spiolto®) | Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | Moderate Exacerbation | 125.6 Days | Standard Deviation 107.4 |
| Tiotropium/Olodaterol (Spiolto®) | Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | Severe Exacerbation | 134.0 Days | Standard Deviation 112.5 |
| Tiotropium/Olodaterol (Spiolto®) | Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | Moderate or Severe | 116.3 Days | Standard Deviation 108.7 |
| Tiotropium (Spiriva®) | Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | Moderate or Severe | 118.8 Days | Standard Deviation 105.9 |
| Tiotropium (Spiriva®) | Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | Moderate Exacerbation | 139.0 Days | Standard Deviation 121.3 |
| Tiotropium (Spiriva®) | Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | Severe Exacerbation | 134.5 Days | Standard Deviation 107.1 |
Comparison: Moderate or Severe COPD Exacerbation95% CI: [0.63, 1.15]
Comparison: Moderate COPD Exacerbation95% CI: [0.43, 1.01]
Comparison: Severe COPD Exacerbation95% CI: [0.62, 1.31]