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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tiotropium/Olodaterol | Combination of Tiotropium and Olodaterol |
| |
| Tiotropium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium/Olodaterol | Drug | Soft Mist Inhaler product |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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. | From index date (cohort entry date) until first occurence of event, up to 42 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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 exclusion criteria will then be applied to generate the unmatched cohort:
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The study cohort will include all patients who initiate Tiotropium/Olodaterol (Tio/Olo) or Tiotropium (Tio) during the patient selection period. Initiation (new use) will be determined based on no prescription claims for Tio/Olo or Tio during the baseline period or during all available data prior to cohort entry date. All patients will additionally be required to have a second claim for the index medication within 60 days after cohort entry to ensure primary adherence of index therapy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nara Medical University | Nara | 634-8522 | Japan |
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| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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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.
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
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. | 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. | Posted | Mean | Standard Deviation | Days | From index date (cohort entry date) until first occurence of event, up to 42 months. |
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As this is a non-interventional study with secondary use of data retrieved from a Japanese database, safety monitoring and safety reporting on an individual case level is not applicable. All-Cause Mortality, Serious Adverse Events and Other Adverse Events are not collected in the database. "0" total Number of Participants at Risk means "All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed".
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Centre | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 27, 2020 | Jul 15, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C000611386 | tiotropium-olodaterol |
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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| Tiotropium | Drug | Soft Mist Inhaler product |
|
|
| From index date until first occurence of event, up to 42 months. |
| 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. | From index date until first occurence of event, up to 42 months. |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | 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. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | 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). |
| OG001 | 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). |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Days | From index date until first occurence of event, up to 42 months. |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Number of Exacerbations | From index date until first occurence of event, up to 42 months. |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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). | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| Severe Exacerbation |
|
Moderate COPD Exacerbation
| Hazard Ratio (HR) |
| 0.66 |
| 2-Sided |
| 95 |
| 0.43 |
| 1.01 |
[(Tiotropium/Olodaterol) / Tiotropium] Cox regression was used to estimate the hazard ratios and 95% confidence intervals. |
| Other |
| Severe COPD Exacerbation | Hazard Ratio (HR) | 0.90 | 2-Sided | 95 | 0.62 | 1.31 | [(Tiotropium/Olodaterol) / Tiotropium] Cox regression was used to estimate the hazard ratios and 95% confidence intervals. | Other |
| Severe Exacerbations |
|