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The primary objective is to compare the effectiveness of maintenance therapy initiation with the combination treatment Tiotropium and Olodaterol (Olo+Tio) compared with LABA/ICS combination in COPD as the time to the first COPD exacerbation.
Secondary objectives are to compare patients treated with Tio+Olo and patients treated with LABA/ ICS combination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients initiating Tiotropium+Olodaterol therapy |
| ||
| Patients initiating Long-acting beta agonist/inhaled corticosteroid therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium bromide + Olodaterol | Drug | Tiotropium bromide + Olodaterol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation after cohort entry. The event was defined as follows: Severe exacerbation: Hospitalization with a principal discharge diagnosis of COPD. or Moderate exacerbation: An emergency department (ED) visit with a discharge diagnosis of COPD, or, an antibiotic for a respiratory condition dispensed the same day as an oral corticosteroid. | From cohort entry (index date) until the occurrence of a hospitalization for COPD (severe exacerbation), ED visit for COPD or prescription of an antibiotic and oral corticosteroid on the same day (moderate exacerbation). Up to one year after cohort entry. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of First Hospitalization for Community-acquired Pneumonia | Incidence rate of first hospitalization for community-acquired pneumonia (serious pneumonia). Pneumonia was defined using ICD-9-CM diagnoses and ICD-10 diagnosis codes. | From cohort entry (index date) until the occurrence of first hospitalization for community-acquired pneumonia (serious pneumonia). Up to one year after cohort entry. |
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Inclusion Criteria:
At least one prescription for Tio+Olo combined inhaler or a LABA/ICS combined inhaler between 1 January 2013 and 31 March 2019.
At least one diagnosis of COPD at any time prior to the index date.
At least one year of continuous medical and pharmacy health plan eligibility prior to the index date will be required to allow a baseline period for the covariates and identification of new use of the study drugs.
Exclusion Criteria:
To increase the likelihood of a true diagnosis of COPD, we will exclude:
To limit the population to those without severe lung compromise outside of COPD, we will exclude individuals with lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date
To restrict the cohort to new users of Tio+Olo or LABA/ICS, we will exclude any individual with use of either Tio+Olo, LABA/ICS, or LABA/LAMA/ICS combination therapy in free or fixed form for at least one year prior to the index date.
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Subjects with COPD inititated with Tio+Olo in comparison to patients treated with ICS/LABA/LAMA
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HealthCore, Inc. | Watertown | Massachusetts | 02472 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33721209 | Derived | Quint JK, Montonen J, Esposito DB, He X, Koerner L, Wallace L, de la Hoz A, Miravitlles M. Effectiveness and Safety of COPD Maintenance Therapy with Tiotropium/Olodaterol versus LABA/ICS in a US Claims Database. Adv Ther. 2021 May;38(5):2249-2270. doi: 10.1007/s12325-021-01646-5. Epub 2021 Mar 15. |
| 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, except for the following exclusions:
For more details refer to: https://www.mystudywindow.com/msw/datasharing
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Only subjects that met all inclusion and none of the exclusion criteria were included. two cohorts (Initiators of Tiotropium + Olodaterol and patients receiving Long-acting beta agonist / inhaled corticosteroid) were established. The cohorts after propensity score matching were used for the analyses
In this cohort study, administrative data from the HealthCore Integrated Research Database (US, HIRD, Jan 2013 - March 2019) were used to identify and compare new users of Tio+Olo (Tiotropium and Olodaterol) with new users of LABA/ICS (Long-acting Beta2-Agonists/Inhaled Corticosteroids) combination therapy with respect to safety and effectiveness.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tiotropium + Olodaterol | Cohort of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from administrative data from the HealthCore Integrated Research Database (HIRD, January 2013 - March 2019), who initiated fixed dose combination (FDC) inhaler treatment of Tiotropium and Olodaterol, with the first prescription defined as the index date. Following the index date participants were followed for up to one year. |
| FG001 | Long-acting Beta Agonist / Inhaled Corticosteroid Therapy | Cohort of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from administrative data from the HealthCore Integrated Research Database (HIRD, January 2013 - March 2019), who initiated long-acting beta agonist / inhaled corticosteroid therapy, with the first prescription defined as the index date. Following the index date participants were followed for up to one year. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Propensity score weighted populations of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from the HealthCore Integrated Research Database (HIRD, January 2013 - March 2019), who initiated fixed dose combination (FDC) inhaler treatment of Tiotropium and Olodaterol or long-acting beta agonist / inhaled corticosteroid therapy.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tiotropium + Olodaterol | Cohort of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from administrative data from the HealthCore Integrated Research Database (HIRD, January 2013 - March 2019), who initiated fixed dose combination (FDC) inhaler treatment of Tiotropium and Olodaterol, with the first prescription defined as the index date. Following the index date participants were followed for up to one year. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation after cohort entry. The event was defined as follows: Severe exacerbation: Hospitalization with a principal discharge diagnosis of COPD. or Moderate exacerbation: An emergency department (ED) visit with a discharge diagnosis of COPD, or, an antibiotic for a respiratory condition dispensed the same day as an oral corticosteroid. | Propensity score weighted populations of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from the HealthCore Integrated Research Database (HIRD, January 2013 - March 2019), who initiated fixed dose combination (FDC) inhaler treatment of Tiotropium and Olodaterol or long-acting beta agonist / inhaled corticosteroid therapy. | Posted | Number | 95% Confidence Interval | Events per 1,000 Person-days | From cohort entry (index date) until the occurrence of a hospitalization for COPD (severe exacerbation), ED visit for COPD or prescription of an antibiotic and oral corticosteroid on the same day (moderate exacerbation). Up to one year after cohort entry. |
|
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As this is a non-interventional study with secondary use of data retrieved from a US health claims database, safety monitoring and safety reporting on an individual case level is not applicable.
Total number of participants at risk is 0 since adverse events were not planned to be collected and reported for this study.
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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 | Cohort of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from administrative data from the HealthCore Integrated Research Database (HIRD, January 2013 - March 2019), who initiated fixed dose combination (FDC) inhaler treatment of Tiotropium and Olodaterol, with the first prescription defined as the index date. Following the index date participants were followed for up to one year. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | 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 19, 2020 | Sep 30, 2020 | 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 |
|---|---|
| D000069447 | Tiotropium Bromide |
| C549647 | olodaterol |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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| LABA/ICS | Drug | Long-acting beta2-agonist and Inhaled corticosteroids (LABA and ICS) |
|
| Incidence Rate of the First Date of a Pharmacy Dispensing Indicating Escalation (Original Case Definition) to Triple Therapy | Incidence rate of the first date of a pharmacy dispensing indicating escalation to triple therapy, (i.e., addition of Inhaled Corticosteroids to Tiotropium and Olodaterol or a Long-acting Muscarinic Antagonists to long-acting beta agonist / inhaled corticosteroid therapy). | From cohort entry (index date) until the escalation, up to one year after cohort entry. |
| Incidence Rate of the First Date of a Pharmacy Dispensing Indicating Escalation (Alternative Case Definition) to Triple Therapy | Incidence rate of the first date of a pharmacy dispensing indicating escalation to triple therapy. Based on feedback from clinical experts during review of study results, an alternative post-hoc definition was also assessed in which initiation of any treatment including simultaneous LABA (long-acting beta agonist) /LAMA (Long-acting Muscarinic Antagonists) /ICS (inhaled corticosteroid therapy) use in free or fixed combination was counted as an outcome. | From cohort entry (index date) until the escalation, up to one year after cohort entry. |
| Incidence Rate of Any Element of a Composite Outcome Including Exacerbation, Hospitalization for Pneumonia, or Escalation (Original Case Definition) to Triple Therapy | Incidence rate of any element of a composite outcome including exacerbation, hospitalization for pneumonia, or escalation (original case definition) to triple therapy. Exacerbation was defined as follows: Severe exacerbation: Hospitalization with a principal discharge diagnosis of COPD. Moderate exacerbation: An emergency department (ED) visit with a discharge diagnosis of COPD, or, an antibiotic for a respiratory condition dispensed the same day as an oral corticosteroid. Pneumonia was defined using ICD-9-CM diagnoses and ICD-10 diagnosis codes. Escalation was defined as the addition of Inhaled Corticosteroids to Tiotropium and Olodaterol or a Long-acting Muscarinic Antagonists to long-acting beta agonist / inhaled corticosteroid therapy. | From cohort entry (index date) until exacerbation, hospitalization (for community-acquired pneumonia) or escalation, up to one year after cohort entry. |
| Incidence Rate of Any Element of a Composite Outcome Including Exacerbation, Hospitalization for Pneumonia, or Escalation (Alternative Case Definition) to Triple Therapy | Incidence rate of any element of a composite outcome including exacerbation, hospitalization for pneumonia, or escalation (alternative case definition) to triple therapy. Exacerbation was defined as follows: Severe exacerbation: Hospitalization with a principal discharge diagnosis of COPD. Moderate exacerbation: An emergency department (ED) visit with a discharge diagnosis of COPD, or, an antibiotic for a respiratory condition dispensed the same day as an oral corticosteroid. Pneumonia was defined using ICD-9-CM diagnoses and ICD-10 diagnosis codes. Escalation was defined as the initiation of any treatment including simultaneous LABA (long-acting beta agonist) /LAMA (Long-acting Muscarinic Antagonists) /ICS (inhaled corticosteroid therapy) use in free or fixed combination. | From cohort entry (index date) until exacerbation, hospitalization (for community-acquired pneumonia) or escalation, up to one year after cohort entry. |
| BG001 | Long-acting Beta Agonist / Inhaled Corticosteroid Therapy | Cohort of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from administrative data from the HealthCore Integrated Research Database (HIRD, January 2013 - March 2019), who initiated long-acting beta agonist / inhaled corticosteroid therapy, with the first prescription defined as the index date. Following the index date participants were followed for up to one year. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | Tiotropium + Olodaterol | Cohort of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from administrative data from the HealthCore Integrated Research Database (HIRD, January 2013 - March 2019), who initiated fixed dose combination (FDC) inhaler treatment of Tiotropium and Olodaterol, with the first prescription defined as the index date. Following the index date participants were followed for up to one year. |
| OG001 | Long-acting Beta Agonist / Inhaled Corticosteroid Therapy | Cohort of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from administrative data from the HealthCore Integrated Research Database (HIRD, January 2013 - March 2019), who initiated long-acting beta agonist / inhaled corticosteroid therapy, with the first prescription defined as the index date. Following the index date participants were followed for up to one year. |
|
|
|
| Secondary | Incidence Rate of First Hospitalization for Community-acquired Pneumonia | Incidence rate of first hospitalization for community-acquired pneumonia (serious pneumonia). Pneumonia was defined using ICD-9-CM diagnoses and ICD-10 diagnosis codes. | Propensity score weighted populations of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from the HealthCore Integrated Research Database (HIRD, January 2013 - March 2019), who initiated fixed dose combination (FDC) inhaler treatment of Tiotropium and Olodaterol or long-acting beta agonist / inhaled corticosteroid therapy. | Posted | Number | 95% Confidence Interval | events per 1,000 Person-days | From cohort entry (index date) until the occurrence of first hospitalization for community-acquired pneumonia (serious pneumonia). Up to one year after cohort entry. |
|
|
|
|
| Secondary | Incidence Rate of the First Date of a Pharmacy Dispensing Indicating Escalation (Original Case Definition) to Triple Therapy | Incidence rate of the first date of a pharmacy dispensing indicating escalation to triple therapy, (i.e., addition of Inhaled Corticosteroids to Tiotropium and Olodaterol or a Long-acting Muscarinic Antagonists to long-acting beta agonist / inhaled corticosteroid therapy). | Propensity score weighted populations of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from the HealthCore Integrated Research Database (HIRD, January 2013 - March 2019), who initiated fixed dose combination (FDC) inhaler treatment of Tiotropium and Olodaterol or long-acting beta agonist / inhaled corticosteroid therapy. | Posted | Number | 95% Confidence Interval | events per 1,000 Person-days | From cohort entry (index date) until the escalation, up to one year after cohort entry. |
|
|
|
|
| Secondary | Incidence Rate of the First Date of a Pharmacy Dispensing Indicating Escalation (Alternative Case Definition) to Triple Therapy | Incidence rate of the first date of a pharmacy dispensing indicating escalation to triple therapy. Based on feedback from clinical experts during review of study results, an alternative post-hoc definition was also assessed in which initiation of any treatment including simultaneous LABA (long-acting beta agonist) /LAMA (Long-acting Muscarinic Antagonists) /ICS (inhaled corticosteroid therapy) use in free or fixed combination was counted as an outcome. | Propensity score weighted populations of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from the HealthCore Integrated Research Database (HIRD, January 2013 - March 2019), who initiated fixed dose combination (FDC) inhaler treatment of Tiotropium and Olodaterol or long-acting beta agonist / inhaled corticosteroid therapy. | Posted | Number | 95% Confidence Interval | events per 1,000 Person-days | From cohort entry (index date) until the escalation, up to one year after cohort entry. |
|
|
|
|
| Secondary | Incidence Rate of Any Element of a Composite Outcome Including Exacerbation, Hospitalization for Pneumonia, or Escalation (Original Case Definition) to Triple Therapy | Incidence rate of any element of a composite outcome including exacerbation, hospitalization for pneumonia, or escalation (original case definition) to triple therapy. Exacerbation was defined as follows: Severe exacerbation: Hospitalization with a principal discharge diagnosis of COPD. Moderate exacerbation: An emergency department (ED) visit with a discharge diagnosis of COPD, or, an antibiotic for a respiratory condition dispensed the same day as an oral corticosteroid. Pneumonia was defined using ICD-9-CM diagnoses and ICD-10 diagnosis codes. Escalation was defined as the addition of Inhaled Corticosteroids to Tiotropium and Olodaterol or a Long-acting Muscarinic Antagonists to long-acting beta agonist / inhaled corticosteroid therapy. | Propensity score weighted populations of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from the HealthCore Integrated Research Database (HIRD, January 2013 - March 2019), who initiated fixed dose combination (FDC) inhaler treatment of Tiotropium and Olodaterol or long-acting beta agonist / inhaled corticosteroid therapy. | Posted | Number | 95% Confidence Interval | events per 1,000 Person-days | From cohort entry (index date) until exacerbation, hospitalization (for community-acquired pneumonia) or escalation, up to one year after cohort entry. |
|
|
|
|
| Secondary | Incidence Rate of Any Element of a Composite Outcome Including Exacerbation, Hospitalization for Pneumonia, or Escalation (Alternative Case Definition) to Triple Therapy | Incidence rate of any element of a composite outcome including exacerbation, hospitalization for pneumonia, or escalation (alternative case definition) to triple therapy. Exacerbation was defined as follows: Severe exacerbation: Hospitalization with a principal discharge diagnosis of COPD. Moderate exacerbation: An emergency department (ED) visit with a discharge diagnosis of COPD, or, an antibiotic for a respiratory condition dispensed the same day as an oral corticosteroid. Pneumonia was defined using ICD-9-CM diagnoses and ICD-10 diagnosis codes. Escalation was defined as the initiation of any treatment including simultaneous LABA (long-acting beta agonist) /LAMA (Long-acting Muscarinic Antagonists) /ICS (inhaled corticosteroid therapy) use in free or fixed combination. | Propensity score weighted populations of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from the HealthCore Integrated Research Database (HIRD, January 2013 - March 2019), who initiated fixed dose combination (FDC) inhaler treatment of Tiotropium and Olodaterol or long-acting beta agonist / inhaled corticosteroid therapy. | Posted | Number | 95% Confidence Interval | events per 1,000 Person-days | From cohort entry (index date) until exacerbation, hospitalization (for community-acquired pneumonia) or escalation, up to one year after cohort entry. |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Long-acting Beta Agonist / Inhaled Corticosteroid Therapy | Cohort of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from administrative data from the HealthCore Integrated Research Database (HIRD, January 2013 - March 2019), who initiated long-acting beta agonist / inhaled corticosteroid therapy, with the first prescription defined as the index date. Following the index date participants were followed for up to one year. | 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 |