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This study is a cross-sectional, non-interventional study based on existing data (NISed).
The UK CPRD data will be used to assess the characteristics of asthma patients who were prescribed ICS/LABA FDC before the index date and who initiated Spiriva Respimat, or received a higher dose of ICS/LABA FDC, or initiated LTRA, or switched to a new ICS/LABA FDC in the UK during the study period (September 2014-December 2017) enabling to assess potential channeling of prescribing to different patient populations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with Asthma | Asthmatic patients prescribed Inhaled corticosteroids/Long-acting beta agonists (ICS/LABA FDC) before index date, initiated with Spiriva Respimat, or received a higher dose of ICS/LABA FDC, initiated LTRA , or switched to a new ICS/LABA FDC fom the previous ICS/LABA FDC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spiriva Respimat | Device | soft-mist inhaler |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Cardiac Arrhythmias | The number of participants who had Cardiac arrhythmias on the index date or in the year prior to the index date. | On the index date or in the year prior to the index date |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Cardiac Failure | The number of participants who had Cardiac failure on the index date or in the year prior to the index date. | On the index date or in the year prior to the index date |
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Inclusion Criteria:
Exclusion Criteria:
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Asthmatic patients who were prescribed ICS/LABA FDC before the index date and who initiated Spiriva Respimat, or received a higher dose of ICS/LABA FDC, or initiated LTRA, or switched to a new ICS/LABA FDC from the previous ICS/LABA FDC in the UK during the study period (September, 2014-December 31, 2017)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim | Ingelheim | Germany |
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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, except for the following exclusions:
For more details refer to: https://www.mystudywindow.com/msw/datasharing
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All subjects were screened for eligibility to participate in trial. Subjects meeting the exclusion criteria were excluded.
This study is a cross-sectional assessment of asthma patients who initiated Spiriva Respimat, who initiated leukotriene receptor antagonist (LTRA), who received a higher dose of ICS/LABA FDC, or who switched to a new ICS/LABA FDC in asthma in the UK during the study period (September, 2014-December 31, 2017). (Non-interventional study based on existing data).
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| ID | Title | Description |
|---|---|---|
| FG000 | Spiriva Respimat | The first Spiriva Respimat prescription record during study period qualifies for cohort entry and its event date will be set as index date. Patients will be excluded if they fulfill any of the following exclusion criteria:
|
| FG001 | Leukotriene Receptor Antagonist (LTRA) | The first LTRA prescription record during study period qualifies for cohort entry and its event date will be set as index date. Patients will be excluded if they fulfill any of the following exclusion criteria:
|
| FG002 | ICS/LABA Fixed Dose Combination (Switchers) | The first ICS/LABA FDC prescription record during study period with different ICS and/or LABA drug substance component as compared to the preceding FDC prescription qualifies for cohort entry and its event date will be set as index date. Same ICS/LABA FDC, but different device (e.g. switch from DPI to pMDI) will trigger cohort entry to this cohort as well. Patients will be excluded if they fulfil any of the following exclusion criteria:
|
| FG003 | ICS Dose Increase of ICS/LABA Fixed Dose Combination User | The first ICS/LABA FDC prescription record during study period which represent a dose increase of ICS daily dose as compared to the preceding FDC prescription qualifies for cohort entry and its event date will be set as index date. Patients will be excluded if they fulfill any of the following exclusion criteria:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Asthma patients who initiated Spiriva Respimat, who initiated leukotriene receptor antagonist (LTRA), who received a higher dose of ICS/LABA FDC, or who switched to a new ICS/LABA FDC in asthma, and who did not violate any of the exclusion criteria, in the United Kingdom during the study period (Sep 2014 - Dec 2017).
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| ID | Title | Description |
|---|---|---|
| BG000 | Spiriva Respimat | The first Spiriva Respimat prescription record during study period qualifies for cohort entry and its event date will be set as index date. Patients will be excluded if they fulfill any of the following exclusion criteria:
|
| 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 | Number of Participants With Cardiac Arrhythmias | The number of participants who had Cardiac arrhythmias on the index date or in the year prior to the index date. | Asthma patients who initiated Spiriva Respimat, who initiated leukotriene receptor antagonist (LTRA), who received a higher dose of ICS/LABA FDC, or who switched to a new ICS/LABA FDC in asthma, and who did not violate any of the exclusion criteria, in the United Kingdom during the studied period (Sep 2014 - Dec 2017). | Posted | Count of Participants | Participants | On the index date or in the year prior to the index date |
|
In this non-interventional study based on existing data, All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
In this non-interventional study based on existing data, 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 | Spiriva Respimat | The first Spiriva Respimat prescription record during study period qualifies for cohort entry and its event date will be set as index date. Patients will be excluded if they fulfill any of the following exclusion criteria:
|
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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 | Yes | No | No | Study Protocol | Aug 3, 2018 | May 11, 2021 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 17, 2019 | May 11, 2021 | SAP_003.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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| exclude patients without concurrent ICS/LABA FDC use |
|
| exclude patients without prior recorded asthma diagnosis |
|
| exclude patients less than 18 years of age on index date |
|
| exclude patients with less than 1 year prior continous UTS enrollment |
|
| exclude patients with prior LAMA use (any time prior to index date) |
|
| exclude patients with prior recorded COPD diagnosis |
|
| exclude patients with multiple FDC prescriptions on index date |
|
| exclude patients with prior use of same substances and device |
|
| exclude patients without ICS/LABA FDC prescription within 3 months prior to index date |
|
| exclude patients with different substance(s)/device at preceding prescription |
|
| Other |
|
| exclude patients with multiple substance(s)/device at preceding prescription |
|
| BG001 | Leukotriene Receptor Antagonist (LTRA) | The first LTRA prescription record during study period qualifies for cohort entry and its event date will be set as index date. Patients will be excluded if they fulfill any of the following exclusion criteria:
|
| BG002 | ICS/LABA Fixed Dose Combination (Switchers) | The first ICS/LABA FDC prescription record during study period with different ICS and/or LABA drug substance component as compared to the preceding FDC prescription qualifies for cohort entry and its event date will be set as index date. Same ICS/LABA FDC, but different device (e.g. switch from DPI to pMDI) will trigger cohort entry to this cohort as well. Patients will be excluded if they fulfil any of the following exclusion criteria:
|
| BG003 | ICS Dose Increase of ICS/LABA Fixed Dose Combination User | The first ICS/LABA FDC prescription record during study period which represent a dose increase of ICS daily dose as compared to the preceding FDC prescription qualifies for cohort entry and its event date will be set as index date. Patients will be excluded if they fulfill any of the following exclusion criteria:
|
| BG004 | Total | Total of all reporting groups |
| Year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Leukotriene Receptor Antagonist (LTRA) | The first LTRA prescription record during study period qualifies for cohort entry and its event date will be set as index date. Patients will be excluded if they fulfill any of the following exclusion criteria:
|
| OG002 | ICS/LABA Fixed Dose Combination (Switchers) | The first ICS/LABA FDC prescription record during study period with different ICS and/or LABA drug substance component as compared to the preceding FDC prescription qualifies for cohort entry and its event date will be set as index date. Same ICS/LABA FDC, but different device (e.g. switch from DPI to pMDI) will trigger cohort entry to this cohort as well. Patients will be excluded if they fulfil any of the following exclusion criteria:
|
| OG003 | ICS Dose Increase of ICS/LABA Fixed Dose Combination User | The first ICS/LABA FDC prescription record during study period which represent a dose increase of ICS daily dose as compared to the preceding FDC prescription qualifies for cohort entry and its event date will be set as index date. Patients will be excluded if they fulfill any of the following exclusion criteria:
|
|
|
| Secondary | Number of Participants With Cardiac Failure | The number of participants who had Cardiac failure on the index date or in the year prior to the index date. | Asthma patients who initiated Spiriva Respimat, who initiated leukotriene receptor antagonist (LTRA), who received a higher dose of ICS/LABA FDC, or who switched to a new ICS/LABA FDC in asthma, and who did not violate any of the exclusion criteria, in the United Kingdom during the studied period (Sep 2014 - Dec 2017). | Posted | Number | Patients with cardiac failures | On the index date or in the year prior to the index date |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Leukotriene Receptor Antagonist (LTRA) | The first LTRA prescription record during study period qualifies for cohort entry and its event date will be set as index date. Patients will be excluded if they fulfill any of the following exclusion criteria:
| 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | ICS/LABA Fixed Dose Combination (Switchers) | The first ICS/LABA FDC prescription record during study period with different ICS and/or LABA drug substance component as compared to the preceding FDC prescription qualifies for cohort entry and its event date will be set as index date. Same ICS/LABA FDC, but different device (e.g. switch from DPI to pMDI) will trigger cohort entry to this cohort as well. Patients will be excluded if they fulfil any of the following exclusion criteria:
| 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | ICS Dose Increase of ICS/LABA Fixed Dose Combination User | The first ICS/LABA FDC prescription record during study period which represent a dose increase of ICS daily dose as compared to the preceding FDC prescription qualifies for cohort entry and its event date will be set as index date. Patients will be excluded if they fulfill any of the following exclusion criteria:
| 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 |