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The purpose of this study is to conduct a comparative analysis of patients using Tiotropium in combination with Inhaled Corticosteroids (ICS) versus those that use long-acting β2-agonists (LABA) medication in combination with ICS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tiotropium + inhaled corticosteroids (ICS) group |
| ||
| long-acting β2-agonists (LABA) + inhaled corticosteroids (ICS) group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tiotropium | Drug | tiotropium |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Severe Exacerbation | Severe exacerbation defined as:
Index date is defined as date when patient entered the cohort. Design 1: A time-varying covariate approach to classify drug exposure time for each comparator drug during follow up was used. For each individual study drug, medication exposure + non-exposure windows during the follow-up time for each medication were identified/defined using date of prescription filled + days' supply listed on prescription claim + 50% additional days. | From index date to first severe exacerbation, up to 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Moderate-or-severe Exacerbation | Severe exacerbation defined as:
Index date is defined as date when patient entered the cohort. Design 1: A time-varying covariate approach to classify drug exposure time for each comparator drug during follow up was used. For each individual study drug, medication exposure + non-exposure windows during the follow-up time for each medication were identified/defined using date of prescription filled + days' supply listed on prescription claim + 50% additional days. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with least two asthma diagnosis will be included. Patients will be required to have enrollment for at least 6 months prior to ICS+Tio or ICS/LABA use.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| eMax Health | White Plains | New York | 10601 | United States |
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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:
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Propensity score matched (PSM) cohorts of patients between the ICS + tiotropium (tio) and ICS/LABA groups. Patients >=12 years with least two asthma diagnosis were included and be required to be concurrently on ICS + tio or ICS/LABA.
The objective of this study was to conduct a retrospective cohort study comparing asthma patients taking tiotropium in combination with inhaled corticosteroids (ICS) versus patients taking long-acting β2-agonists (LABA) medication in combination with ICS.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tiotropium (Tio) + Inhaled Corticosteroids (ICS) Cohort | Patients with at least two asthma diagnosis who were treated concurrently with inhaled corticosteroids (ICS) + tiotropium (specifically tiotropium Respimat 1.25 mcg) between 2014 and 2020. Patients were matched to patients receiving inhaled corticosteroids (ICS) + long-acting β2-agonists (LABA) using a time-conditional propensity score-matched approach. |
| FG001 | Long-acting β2-agonists (LABA) + Inhaled Corticosteroids (ICS) Cohort | Patients with at least two asthma diagnosis who were treated concurrently with inhaled corticosteroids (ICS) + long-acting β2-agonists (LABA) between 2014 and 2020. Patients were matched to patients receiving inhaled corticosteroids (ICS) + tiotropium (specifically tiotropium Respimat 1.25 mcg) using a time-conditional propensity score-matched approach. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The main analysis was on matched cohorts of patients between the ICS + tio and ICS/LABA cohorts using a 1:2 propensity score matching (PSM) approach. PSM resulted in a match of each ICS + tio patient to 2 ICS/LABA patients. Baseline measures were presented for matched populations.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tiotropium (Tio) + Inhaled Corticosteroids (ICS) Cohort | Patients with at least two asthma diagnosis who were treated concurrently with inhaled corticosteroids (ICS) + tiotropium (specifically tiotropium Respimat 1.25 mcg) between 2014 and 2020. Patients were matched to patients receiving inhaled corticosteroids (ICS) + long-acting β2-agonists (LABA) using a time-conditional propensity score-matched approach. |
| 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 | Time to First Severe Exacerbation | Severe exacerbation defined as:
Index date is defined as date when patient entered the cohort. Design 1: A time-varying covariate approach to classify drug exposure time for each comparator drug during follow up was used. For each individual study drug, medication exposure + non-exposure windows during the follow-up time for each medication were identified/defined using date of prescription filled + days' supply listed on prescription claim + 50% additional days. | The main analysis was on matched cohorts of patients between the ICS + tio and ICS/LABA cohorts using a 1:2 propensity score matching (PSM) approach. PSM resulted in a match of each ICS + tio patient to 2 ICS/LABA patients. Values were presented for matched populations. Only patients with severe exacerbation were included in this analysis. | Posted | Mean | Standard Deviation | Days | From index date to first severe exacerbation, up to 1 year. | observations | observations |
Adverse event information was not applicable for this study.
This was an observational study and was not designed to assess adverse event; therefore safety reporting was not applicable for this study. Adverse events were not planned to be collected as defined in the study protocol. 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 (Tio) + Inhaled Corticosteroids (ICS) Cohort | Patients with at least two asthma diagnosis who were treated concurrently with inhaled corticosteroids (ICS) + tiotropium (specifically tiotropium Respimat 1.25 mcg) between 2014 and 2020. Patients were matched to patients receiving inhaled corticosteroids (ICS) + long-acting β2-agonists (LABA) using a time-conditional propensity score-matched approach. |
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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 | Dec 5, 2021 | Oct 12, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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| long-acting β2-agonists (LABA) |
| Drug |
long-acting β2-agonists (LABA) |
|
| inhaled corticosteroids (ICS) | Drug | inhaled corticosteroids (ICS) |
|
| From index date to first moderate-or-severe exacerbation, up to 1 year. |
| Percentage of Patients With Exacerbation | Percentage of patients with exacerbation is presented. Design 2: The second analysis, included on an ad-hoc basis was using an intent-to-treat (ITT) design where patients were assigned to the cohort, they were part of at the index date. | From index date through first report of exacerbation, up to 1 year. |
| Rate of Exacerbation at 6 Months and One Year | Rate of exacerbation at 6 months and one year is presented. | at 6 months and one year |
| Percentage of Patients With Health Care Resource Utilization (HCRU) | Percentage of patients with Health care resource utilization (HCRU) is presented and is defined as hospitalizations, emergency room (ER) visits, and outpatient visits during follow-up, all-cause and asthma related. | From index date to end of follow-up, up to 1 year. |
| Health Care Resource Utilization (HCRU) | Health care resource utilization (HCRU) are presented including frequency of hospitalizations, ER visits, outpatient visits. Outpatient visits are defined as clinic, hospital, or other medical institution (e.g. public health, etc.) visit as an outpatient. Mean and standard deviations of:
| From index date to end of follow-up, up to 1 year. |
| Percentage of Patients With Use of Rescue Medications | Percentage of patients with use of rescue medications is presented. Use of rescue medication is defined as patients with one or more short-acting β2-agonists (SABA) claims during the follow-up period. | From index date to end of follow-up, up to 1 year. |
| BG001 | Long-acting β2-agonists (LABA) + Inhaled Corticosteroids (ICS) Cohort | Patients with at least two asthma diagnosis who were treated concurrently with inhaled corticosteroids (ICS) + long-acting β2-agonists (LABA) between 2014 and 2020. Patients were matched to patients receiving inhaled corticosteroids (ICS) + tiotropium (specifically tiotropium Respimat 1.25 mcg) using a time-conditional propensity score-matched approach. |
| 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. | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Tiotropium (Tio) + Inhaled Corticosteroids (ICS) Cohort | Patients with at least two asthma diagnosis who were treated concurrently with inhaled corticosteroids (ICS) + tiotropium (specifically tiotropium Respimat 1.25 mcg) between 2014 and 2020. Patients were matched to patients receiving inhaled corticosteroids (ICS) + long-acting β2-agonists (LABA) using a time-conditional propensity score-matched approach. |
| OG001 | Long-acting β2-agonists (LABA) + Inhaled Corticosteroids (ICS) Cohort | Patients with at least two asthma diagnosis who were treated concurrently with inhaled corticosteroids (ICS) + long-acting β2-agonists (LABA) between 2014 and 2020. Patients were matched to patients receiving inhaled corticosteroids (ICS) + tiotropium (specifically tiotropium Respimat 1.25 mcg) using a time-conditional propensity score-matched approach. |
|
|
|
| Secondary | Time to First Moderate-or-severe Exacerbation | Severe exacerbation defined as:
Index date is defined as date when patient entered the cohort. Design 1: A time-varying covariate approach to classify drug exposure time for each comparator drug during follow up was used. For each individual study drug, medication exposure + non-exposure windows during the follow-up time for each medication were identified/defined using date of prescription filled + days' supply listed on prescription claim + 50% additional days. | The main analysis was on matched cohorts of patients between the ICS + tio and ICS/LABA cohorts using a 1:2 propensity score matching (PSM) approach. PSM resulted in a match of each ICS + tio patient to 2 ICS/LABA patients. Values were presented for matched populations. Only patients with moderate-to-severe exacerbation were included in this analysis. | Posted | Mean | Standard Deviation | Days | From index date to first moderate-or-severe exacerbation, up to 1 year. | observations | observations |
|
|
|
|
| Secondary | Percentage of Patients With Exacerbation | Percentage of patients with exacerbation is presented. Design 2: The second analysis, included on an ad-hoc basis was using an intent-to-treat (ITT) design where patients were assigned to the cohort, they were part of at the index date. | The main analysis was on matched cohorts of patients between the ICS + tio and ICS/LABA cohorts using a 1:2 propensity score matching (PSM) approach. PSM resulted in a match of each ICS + tio patient to 2 ICS/LABA patients. Values were presented for matched populations. | Posted | Number | Percentage of Participants | From index date through first report of exacerbation, up to 1 year. |
|
|
|
|
| Secondary | Rate of Exacerbation at 6 Months and One Year | Rate of exacerbation at 6 months and one year is presented. | The main analysis was on matched cohorts of patients between the ICS + tio and ICS/LABA cohorts using a 1:2 propensity score matching (PSM) approach. PSM resulted in a match of each ICS + tio patient to 2 ICS/LABA patients. Values were presented for matched populations. | Posted | Number | Events per 100 person years | at 6 months and one year |
|
|
|
|
| Secondary | Percentage of Patients With Health Care Resource Utilization (HCRU) | Percentage of patients with Health care resource utilization (HCRU) is presented and is defined as hospitalizations, emergency room (ER) visits, and outpatient visits during follow-up, all-cause and asthma related. | The main analysis was on matched cohorts of patients between the ICS + tio and ICS/LABA cohorts using a 1:2 propensity score matching (PSM) approach. PSM resulted in a match of each ICS + tio patient to 2 ICS/LABA patients. Values were presented for matched populations. | Posted | Number | Percentage of Participants | From index date to end of follow-up, up to 1 year. |
|
|
|
|
| Secondary | Health Care Resource Utilization (HCRU) | Health care resource utilization (HCRU) are presented including frequency of hospitalizations, ER visits, outpatient visits. Outpatient visits are defined as clinic, hospital, or other medical institution (e.g. public health, etc.) visit as an outpatient. Mean and standard deviations of:
| The main analysis was on matched cohorts of patients between the ICS + tio and ICS/LABA cohorts using a 1:2 propensity score matching (PSM) approach. PSM resulted in a match of each ICS + tio patient to 2 ICS/LABA patients. Values were presented for matched populations. | Posted | Mean | Standard Deviation | Count of HCRU per person per month | From index date to end of follow-up, up to 1 year. |
|
|
|
|
| Secondary | Percentage of Patients With Use of Rescue Medications | Percentage of patients with use of rescue medications is presented. Use of rescue medication is defined as patients with one or more short-acting β2-agonists (SABA) claims during the follow-up period. | The main analysis was on matched cohorts of patients between the ICS + tio and ICS/LABA cohorts using a 1:2 propensity score matching (PSM) approach. PSM resulted in a match of each ICS + tio patient to 2 ICS/LABA patients. Values were presented for matched populations. | Posted | Number | Percentage of Participants | From index date to end of follow-up, up to 1 year. |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Long-acting β2-agonists (LABA) + Inhaled Corticosteroids (ICS) Cohort | Patients with at least two asthma diagnosis who were treated concurrently with inhaled corticosteroids (ICS) + long-acting β2-agonists (LABA) between 2014 and 2020. Patients were matched to patients receiving inhaled corticosteroids (ICS) + tiotropium (specifically tiotropium Respimat 1.25 mcg) using a time-conditional propensity score-matched approach. | 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.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D009930 |
| Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| Incidence rate ratio |
| 1.005 |
| 2-Sided |
| 95 |
| 0.513 |
| 1.969 |
Incidence rate ratio at 12 months |
| Other |
| Emergency department (ED) visits |
|
| Asthma-related ED visits |
|
| outpatient (OP) visits |
|
| Asthma-related OP visits |
|
| 0.553 |
| Other |
| ED visits | Chi-squared | 0.192 | Other |
| Asthma-related ED visits | Chi-squared | 0.383 | Other |
| OP visits | Chi-squared | 0.338 | Other |
| Asthma-related OP visits | Chi-squared | <0.0001 | Other |
| Emergency department (ED) visits |
|
| Asthma-related ED visits |
|
| Outpatient (OP) visits |
|
| Asthma-related OP visits |
|
| 0.913 |
| Other |
| ED visits | t-test, 2 sided | 0.688 | Other |
| Asthma-related ED visits | t-test, 2 sided | 0.892 | Other |
| OP visits | t-test, 2 sided | <0.0001 | Other |
| Asthma-related OP visits | t-test, 2 sided | 0.002 | Other |