Trial Outcomes & Findings for Early Intervention Efficacy in COPD (NCT NCT04249310)
NCT ID: NCT04249310
Last Updated: 2022-06-14
Results Overview
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.
COMPLETED
6788 participants
From index date (cohort entry date) until first occurence of event, up to 42 months.
2022-06-14
Participant Flow
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).
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.
Participant milestones
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
1436
|
5352
|
|
Overall Study
PS-matched Cohort
|
1412
|
1412
|
|
Overall Study
hdPS-matched Cohort
|
1302
|
1302
|
|
Overall Study
COMPLETED
|
1436
|
5352
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Tiotropium/Olodaterol (Spiolto®)
n=1436 Participants
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).
|
Tiotropium (Spiriva®)
n=5352 Participants
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).
|
Total
n=6788 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.16 Years
STANDARD_DEVIATION 8.41 • n=1436 Participants
|
75.56 Years
STANDARD_DEVIATION 8.90 • n=5352 Participants
|
75.48 Years
STANDARD_DEVIATION 8.80 • n=6788 Participants
|
|
Sex: Female, Male
Female
|
163 Participants
n=1436 Participants
|
779 Participants
n=5352 Participants
|
942 Participants
n=6788 Participants
|
|
Sex: Female, Male
Male
|
1273 Participants
n=1436 Participants
|
4573 Participants
n=5352 Participants
|
5846 Participants
n=6788 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Tiotropium/Olodaterol (Spiolto®)
n=1302 Participants
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).
|
Tiotropium (Spiriva®)
n=1302 Participants
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).
|
|---|---|---|
|
Time to Triple Therapy Initiation
|
195.0 Days
Standard Deviation 123.2
|
89.5 Days
Standard Deviation 112.3
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Tiotropium/Olodaterol (Spiolto®)
n=1302 Participants
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).
|
Tiotropium (Spiriva®)
n=1302 Participants
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).
|
|---|---|---|
|
Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Moderate or Severe
|
116.3 Days
Standard Deviation 108.7
|
118.8 Days
Standard Deviation 105.9
|
|
Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Moderate Exacerbation
|
125.6 Days
Standard Deviation 107.4
|
139.0 Days
Standard Deviation 121.3
|
|
Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Severe Exacerbation
|
134.0 Days
Standard Deviation 112.5
|
134.5 Days
Standard Deviation 107.1
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Tiotropium/Olodaterol (Spiolto®)
n=1436 Participants
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).
|
Tiotropium (Spiriva®)
n=5352 Participants
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).
|
|---|---|---|
|
Number of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Moderate or Severe Exacerbations
|
0.08 Number of Exacerbations
Standard Deviation 0.33
|
0.08 Number of Exacerbations
Standard Deviation 0.34
|
|
Number of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Moderate Exacerbations
|
0.04 Number of Exacerbations
Standard Deviation 0.22
|
0.04 Number of Exacerbations
Standard Deviation 0.22
|
|
Number of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Severe Exacerbations
|
0.05 Number of Exacerbations
Standard Deviation 0.24
|
0.05 Number of Exacerbations
Standard Deviation 0.27
|
Adverse Events
Tiotropium/Olodaterol (Spiolto®)
Tiotropium (Spiriva®)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Centre
Boehringer Ingelheim
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