Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the effectiveness of add on therapy with Tiotropium Respimat® compared to increasing the dose of ICS in patients with a diagnosis of Asthma and on ICS/LABA therapy
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Asthma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium Respimat® | Drug | Tiotropium Respimat® 1.25 mcg (on top of baseline Inhaled Corticosteroid/Long-acting beta-agonist ) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Exacerbation | Exacerbations will be defined as either a hospitalization with a primary diagnosis of asthma, an emergency room (ER) visit with a primary diagnosis of asthma, an asthma exacerbation diagnosis recorded. | From baseline until end of follow-up, up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Exacerbation at 6 Months and 1 Year of Follow-up | Exacerbation rate per 100 person-years. Follow-up period was from index date (date of the first prescription for Tiotropium Respimat® 1.25 mcg in Tio group; date of the first prescription from low to medium/high does or medium to high does or additional high-does of Inhaled Corticosteroid (ICS)/long-acting beta-agonists (LABA) for NonTio group). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Asthmatics 6 years and above on ICS/LABA at baselineIMS Pharmetrics (IMS or Database I); EMRClaims+ (Database II)
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| eMax Health | White Plains | New York | 10601 | United States |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https:// trials.boehringer-ingelheim.com/trial_results/ clinical_submission_documents.html to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link http://trials.boehringeringelheim. com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
This study included asthma patients from two retrospective data sources (IMS Pharmetrics and EMRClaims+) after propensity score matching based on ICS/LABA dose on initiation date, demographics, Charlson Comorbidity index (CCI) score, specific comorbidities, medications and asthma control status.
A retrospective cohort data analysis evaluated the effectiveness of add on therapy with Tiotropium Respimat® 1.25 microgram comparing to increasing the dose of Inhaled Corticosteroid (ICS) in patients with a diagnosis of Asthma and on ICS/Long-acting beta-agonist (LABA) therapy.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tiotropium Respimat® (Tio Group) | 1.25 microgram (mcg) of solution of inhalation of Tiotropium Respimat® added-on to Inhaled Corticosteroid (ICS)/long-acting beta-agonists (LABA) therapy. Advair Diskus, Advair HFA, AirDuo, Breo, Dulera or Symbicort were used for the ICS/LABA therapy from low dose (Advair Diskus (100mcg), Advair HFA (45mcg), AirDuo (55mcg), Breo (100mcg), Dulera (100mcg), Symbicort (80mcg)), to medium dose (Advair Diskus (250mcg), Advair HFA (115mcg), AirDuo (113mcg)) and high dose (Advair Diskus (500mcg), Advair HFA (230mcg), AirDuo (232mcg), Breo (200mcg), Dulera (200mcg), Symbicort (160mcg)). |
| FG001 | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | Low dose ICS/LABA to medium/high dose ICS/LABA or from baseline medium dose ICS/LABA to high dose ICS/LABA or an additional prescription/refill of high-dose ICS/LABA following the first prescription of baseline high dose ICS/LABA within the study period. Advair Diskus, Advair HFA, AirDuo, Breo, Dulera or Symbicort were used for the ICS/LABA therapy from low dose (Advair Diskus (100mcg), Advair HFA (45mcg), AirDuo (55mcg), Breo (100mcg), Dulera (100mcg), Symbicort (80mcg)), to medium dose (Advair Diskus (250mcg), Advair HFA (115mcg), AirDuo (113mcg)) and high dose (Advair Diskus (500mcg), Advair HFA (230mcg), AirDuo (232mcg), Breo (200mcg), Dulera (200mcg), Symbicort (160mcg)). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This study included asthma patients from two retrospective data sources (IMS Pharmetrics and EMRClaims+) after propensity score matching based on ICS/LABA dose on initiation date, demographics, Charlson Comorbidity index (CCI) score, specific comorbidities, medications and asthma control status.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tiotropium Respimat® (Tio Group) | 1.25 microgram (mcg) of solution of inhalation of Tiotropium Respimat® added-on to Inhaled Corticosteroid (ICS)/long-acting beta-agonists (LABA) therapy. Advair Diskus, Advair HFA, AirDuo, Breo, Dulera or Symbicort were used for the ICS/LABA therapy from low dose (Advair Diskus (100mcg), Advair HFA (45mcg), AirDuo (55mcg), Breo (100mcg), Dulera (100mcg), Symbicort (80mcg)), to medium dose (Advair Diskus (250mcg), Advair HFA (115mcg), AirDuo (113mcg)) and high dose (Advair Diskus (500mcg), Advair HFA (230mcg), AirDuo (232mcg), Breo (200mcg), Dulera (200mcg), Symbicort (160mcg)). |
| 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 Exacerbation | Exacerbations will be defined as either a hospitalization with a primary diagnosis of asthma, an emergency room (ER) visit with a primary diagnosis of asthma, an asthma exacerbation diagnosis recorded. | This study included asthma patients from two retrospective data sources (IMS Pharmetrics and EMRClaims+) after propensity score matching based on ICS/LABA dose on initiation date, demographics, Charlson Comorbidity index (CCI) score, specific comorbidities, medications and asthma control status. | Posted | Mean | Standard Deviation | Days | From baseline until end of follow-up, up to 3 years |
|
Adverse event information was not applicable for this study
As this is a non-interventional study with secondary use of data retrieved from IMS Pharmetrics and EMRClaims+® database, safety monitoring and safety reporting on an individual case level is not applicable.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tiotropium Respimat® (Tio Group) | 1.25 microgram (mcg) of solution of inhalation of Tiotropium Respimat® added-on to Inhaled Corticosteroid (ICS)/long-acting beta-agonists (LABA) therapy. Advair Diskus, Advair HFA, AirDuo, Breo, Dulera or Symbicort were used for the ICS/LABA therapy from low dose (Advair Diskus (100mcg), Advair HFA (45mcg), AirDuo (55mcg), Breo (100mcg), Dulera (100mcg), Symbicort (80mcg)), to medium dose (Advair Diskus (250mcg), Advair HFA (115mcg), AirDuo (113mcg)) and high dose (Advair Diskus (500mcg), Advair HFA (230mcg), AirDuo (232mcg), Breo (200mcg), Dulera (200mcg), Symbicort (160mcg)). |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| 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 18, 2019 | Sep 3, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000611386 | tiotropium-olodaterol |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Inhaled Corticosteroid/Long-acting beta-agonist | Drug | baseline low dose to medium/high dose, baseline medium dose ICS/LABA to high dose ICS/LABA, additional prescription/refill of high-dose-ICS/LABA following the first prescription of baseline high dose ICS/LABA |
|
| At 6 month and 1 year of follow-up |
| Health Care Resource Utilization (HCRU) During Follow-up | Follow-up period was from index date (date of the first prescription for Tiotropium Respimat® 1.25 mcg in Tio group; date of the first prescription from low to medium/high does or medium to high does or additional high-does of Inhaled Corticosteroid (ICS)/long-acting beta-agonists (LABA) for NonTio group) and up to 3 years of study period. | During follow-up period, From baseline until end of follow-up, up to 3 years |
| Change in Lung Function (Forced Expiratory Volume in 1 Second (FEV1) Score) at Baseline and Follow up Period | Follow-up period was from index date (date of the first prescription for Tiotropium Respimat® 1.25 mcg in Tio group; date of the first prescription from low to medium/high does or medium to high does or additional high-does of Inhaled Corticosteroid (ICS)/long-acting beta-agonists (LABA) for NonTio group) and up to 3 years of study period. FEV1 score range from 0 to 100. Higher FEV1 score suggests normal lung function, while lower for dangerous. Only the descriptive statistics of FEV1 score were reported other than change of FEV1 score from baseline due to lack of enough data points. | From baseline until end of follow-up, up to 3 years |
| Change in Asthma Control Test (ACT) Score at Baseline and in the Follow up Period | Follow-up period was from index date (date of the first prescription for Tiotropium Respimat® 1.25 mcg in Tio group; date of the first prescription from low to medium/high does or medium to high does or additional high-does of Inhaled Corticosteroid (ICS)/long-acting beta-agonists (LABA) for NonTio group) and up to 3 years of study period. ACT score is based on a range of 5 to 25. Higher score indicates better asthma control. A score of 19 or less may be a sign that asthma symptoms not under control. Only the descriptive statistics of ACT score were reported other than change of ACT score from baseline due to lack of enough data points. | From baseline until end of follow-up, up to 3 years |
| BG001 | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | Low dose ICS/LABA to medium/high dose ICS/LABA or from baseline medium dose ICS/LABA to high dose ICS/LABA or an additional prescription/refill of high-dose ICS/LABA following the first prescription of baseline high dose ICS/LABA within the study period. Advair Diskus, Advair HFA, AirDuo, Breo, Dulera or Symbicort were used for the ICS/LABA therapy from low dose (Advair Diskus (100mcg), Advair HFA (45mcg), AirDuo (55mcg), Breo (100mcg), Dulera (100mcg), Symbicort (80mcg)), to medium dose (Advair Diskus (250mcg), Advair HFA (115mcg), AirDuo (113mcg)) and high dose (Advair Diskus (500mcg), Advair HFA (230mcg), AirDuo (232mcg), Breo (200mcg), Dulera (200mcg), Symbicort (160mcg)). |
| 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 |
|
| OG001 | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | Low dose ICS/LABA to medium/high dose ICS/LABA or from baseline medium dose ICS/LABA to high dose ICS/LABA or an additional prescription/refill of high-dose ICS/LABA following the first prescription of baseline high dose ICS/LABA within the study period. Advair Diskus, Advair HFA, AirDuo, Breo, Dulera or Symbicort were used for the ICS/LABA therapy from low dose (Advair Diskus (100mcg), Advair HFA (45mcg), AirDuo (55mcg), Breo (100mcg), Dulera (100mcg), Symbicort (80mcg)), to medium dose (Advair Diskus (250mcg), Advair HFA (115mcg), AirDuo (113mcg)) and high dose (Advair Diskus (500mcg), Advair HFA (230mcg), AirDuo (232mcg), Breo (200mcg), Dulera (200mcg), Symbicort (160mcg)). |
|
|
|
| Secondary | Rate of Exacerbation at 6 Months and 1 Year of Follow-up | Exacerbation rate per 100 person-years. Follow-up period was from index date (date of the first prescription for Tiotropium Respimat® 1.25 mcg in Tio group; date of the first prescription from low to medium/high does or medium to high does or additional high-does of Inhaled Corticosteroid (ICS)/long-acting beta-agonists (LABA) for NonTio group). | This study included asthma patients from two retrospective data sources (IMS Pharmetrics and EMRClaims+) after propensity score matching based on ICS/LABA dose on initiation date, demographics, Charlson Comorbidity index (CCI) score, specific comorbidities, medications and asthma control status. | Posted | Number | Events per 100 person-years | At 6 month and 1 year of follow-up |
|
|
|
|
| Secondary | Health Care Resource Utilization (HCRU) During Follow-up | Follow-up period was from index date (date of the first prescription for Tiotropium Respimat® 1.25 mcg in Tio group; date of the first prescription from low to medium/high does or medium to high does or additional high-does of Inhaled Corticosteroid (ICS)/long-acting beta-agonists (LABA) for NonTio group) and up to 3 years of study period. | This study included asthma patients from two retrospective data sources (IMS Pharmetrics and EMRClaims+) after propensity score matching based on ICS/LABA dose on initiation date, demographics, Charlson Comorbidity index (CCI) score, specific comorbidities, medications and asthma control status. | Posted | Number | Events per 100 person-years | During follow-up period, From baseline until end of follow-up, up to 3 years |
|
|
|
| Secondary | Change in Lung Function (Forced Expiratory Volume in 1 Second (FEV1) Score) at Baseline and Follow up Period | Follow-up period was from index date (date of the first prescription for Tiotropium Respimat® 1.25 mcg in Tio group; date of the first prescription from low to medium/high does or medium to high does or additional high-does of Inhaled Corticosteroid (ICS)/long-acting beta-agonists (LABA) for NonTio group) and up to 3 years of study period. FEV1 score range from 0 to 100. Higher FEV1 score suggests normal lung function, while lower for dangerous. Only the descriptive statistics of FEV1 score were reported other than change of FEV1 score from baseline due to lack of enough data points. | This study included asthma patients from two retrospective data sources (IMS Pharmetrics and EMRClaims+) after propensity score matching based on ICS/LABA dose on initiation date, demographics, CCI score, specific comorbidities, medications and asthma control status. Analysis conducted with participants with non-missing endpoint results. | Posted | Mean | Standard Deviation | Score on a scale | From baseline until end of follow-up, up to 3 years |
|
|
|
| Secondary | Change in Asthma Control Test (ACT) Score at Baseline and in the Follow up Period | Follow-up period was from index date (date of the first prescription for Tiotropium Respimat® 1.25 mcg in Tio group; date of the first prescription from low to medium/high does or medium to high does or additional high-does of Inhaled Corticosteroid (ICS)/long-acting beta-agonists (LABA) for NonTio group) and up to 3 years of study period. ACT score is based on a range of 5 to 25. Higher score indicates better asthma control. A score of 19 or less may be a sign that asthma symptoms not under control. Only the descriptive statistics of ACT score were reported other than change of ACT score from baseline due to lack of enough data points. | This study included asthma patients from two retrospective data sources (IMS Pharmetrics and EMRClaims+) after propensity score matching based on ICS/LABA dose on initiation date, demographics, CCI score, specific comorbidities, medications and asthma control status. Analysis conducted with participants with non-missing endpoint results. | Posted | Mean | Standard Deviation | Score on a scale | From baseline until end of follow-up, up to 3 years |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | Low dose ICS/LABA to medium/high dose ICS/LABA or from baseline medium dose ICS/LABA to high dose ICS/LABA or an additional prescription/refill of high-dose ICS/LABA following the first prescription of baseline high dose ICS/LABA within the study period. Advair Diskus, Advair HFA, AirDuo, Breo, Dulera or Symbicort were used for the ICS/LABA therapy from low dose (Advair Diskus (100mcg), Advair HFA (45mcg), AirDuo (55mcg), Breo (100mcg), Dulera (100mcg), Symbicort (80mcg)), to medium dose (Advair Diskus (250mcg), Advair HFA (115mcg), AirDuo (113mcg)) and high dose (Advair Diskus (500mcg), Advair HFA (230mcg), AirDuo (232mcg), Breo (200mcg), Dulera (200mcg), Symbicort (160mcg)). | 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 |
| Negative binomial regression |
| < 0.0001 |
| Other |
| Emergency room (ER) visit (all cause) |
|
| ER visit (asthma related) |
|
| Outpatient (OP) visit (all cause) |
|
| OP visit (asthma related) |
|