Asthma
Conditions
Brief summary
This study is a cross-sectional, non-interventional study based on existing data (NISed).
Detailed description
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.
Interventions
DEVICESpiriva Respimat
soft-mist inhaler
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years and above at the index date * At least 12 months of continuous registration prior to the index date in a practice contributing up to standard (UTS) data to the Clinical Practice Research Database (CPRD) * Had a diagnosis of asthma before the index date * Being treated with Inhaled corticosteroids/Long-acting beta agonists (ICS LABA FDC) before the index date (at least one prescription within 3 months before the index date) * Patients who were new users of Spiriva Respimat, or LTRA, or patients who were prescribed a higher dose of ICS/LABA FDC, or patients who switched to a new ICS/LABA FDC from the previous ICS/LABA FDC
Exclusion criteria
* Patients who were prescribed other Long-acting muscarinic antagonists (LAMA) any time before or on the index date * In the primary analysis, patients who were diagnosed with COPD before or on the index date will be excluded from the study. In a sensitivity analysis, patients who had both asthma and COPD diagnoses will be included in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Cardiac Arrhythmias | On the index date or in the year prior to the index date | The number of participants who had Cardiac arrhythmias on the index date or in the year prior to the index date. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Cardiac Failure | On the index date or in the year prior to the index date | The number of participants who had Cardiac failure on the index date or in the year prior to the index date. |
Countries
Germany
Participant flow
Recruitment details
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).
Pre-assignment details
All subjects were screened for eligibility to participate in trial. Subjects meeting the exclusion criteria were excluded.
Participants by arm
| Arm | Count |
|---|---|
| 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:
* prior Spiriva Respimat use before index date
* no Inhaled corticosteroids (ICS)/ Long-acting beta agonists (LABA) Fixed Dose Combination (FDC) Prescription Record (Rx) within 3 months before index date
* no prior asthma Diagnosis Record (Dx) before index date
* age on index date less than 18 years
* on index date less than 365 days prior Up-to-standard (UTS) registration
* prior Chronic Obstructive Pulmonary Disease (COPD) Dx before index date (including index date)
* any prior Long-acting muscarinic antagonists (LAMA) use (including index date) | 940 |
| 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:
* prior LTRA use before index date
* no ICS/LABA FDC Rx within 3 months before index date
* no prior asthma Dx before index date age on index date less than 18 years
* on index date less than 365 days prior UTS registration
* prior COPD Dx before index date (including index date)
* any prior LAMA use before index date (including index date) | 3,704 |
| 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:
* prior use of the same ICS/LABA FDC (evaluated on drug substance and device level) before index date
* preceding ICS/LABA FDC Rx not within 3 months before index date
* no prior asthma Dx before index date
* age on index date less than 18 years
* on index date less than 365 days prior UTS registration
* prior COPD Dx before index date (including index date)
* any prior LAMA use before index date (including index date) | 11,135 |
| 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:
* preceding ICS/LABA FDC Rx within 3 months before index date
* no prior asthma Dx before index date
* age on index date less than 18 years
* on index date less than 365 days prior UTS registration
* prior COPD Dx before index date (incl. index date)
* any prior LAMA use before index date (incl. index date) | 1,561 |
| Total | 17,340 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | exclude patients less than 18 years of age on index date | 8 | 613 | 836 | 193 |
| Overall Study | exclude patients with different substance(s)/device at preceding prescription | 0 | 0 | 0 | 223 |
| Overall Study | exclude patients with less than 1 year prior continous UTS enrollment | 149 | 717 | 1,723 | 273 |
| Overall Study | exclude patients with multiple FDC prescriptions on index date | 0 | 0 | 1,147 | 4 |
| Overall Study | exclude patients with multiple substance(s)/device at preceding prescription | 0 | 0 | 0 | 3 |
| Overall Study | exclude patients without concurrent ICS/LABA FDC use | 2,480 | 19,037 | 0 | 0 |
| Overall Study | exclude patients without ICS/LABA FDC prescription within 3 months prior to index date | 0 | 0 | 14,965 | 1,198 |
| Overall Study | exclude patients without prior recorded asthma diagnosis | 881 | 563 | 6,281 | 558 |
| Overall Study | exclude patients with prior LAMA use (any time prior to index date) | 1,208 | 759 | 7,419 | 684 |
| Overall Study | exclude patients with prior recorded COPD diagnosis | 275 | 218 | 1,515 | 173 |
| Overall Study | exclude patients with prior use | 4,424 | 24,726 | 0 | 0 |
| Overall Study | exclude patients with prior use of same substances and device | 0 | 0 | 3,700 | 0 |
| Overall Study | Other | 0 | 805 | 758 | 277 |
Baseline characteristics
| Characteristic | Spiriva Respimat | Total | ICS Dose Increase of ICS/LABA Fixed Dose Combination User | ICS/LABA Fixed Dose Combination (Switchers) | Leukotriene Receptor Antagonist (LTRA) |
|---|---|---|---|---|---|
| Age, Continuous | 54.22 Year STANDARD_DEVIATION 15.741 | 52.34 Year STANDARD_DEVIATION 16.77 | 51.91 Year STANDARD_DEVIATION 17.189 | 53.31 Year STANDARD_DEVIATION 16.961 | 49.12 Year STANDARD_DEVIATION 16.299 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 25 Participants | 367 Participants | 42 Participants | 210 Participants | 90 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 119 Participants | 9 Participants | 71 Participants | 30 Participants |
| Race (NIH/OMB) More than one race | 13 Participants | 166 Participants | 14 Participants | 99 Participants | 40 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 366 Participants | 7493 Participants | 720 Participants | 4859 Participants | 1548 Participants |
| Race (NIH/OMB) White | 527 Participants | 9195 Participants | 776 Participants | 5896 Participants | 1996 Participants |
| Sex: Female, Male Female | 653 Participants | 11232 Participants | 979 Participants | 7121 Participants | 2479 Participants |
| Sex: Female, Male Male | 287 Participants | 6108 Participants | 582 Participants | 4014 Participants | 1225 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: On the index date or in the year prior to the index date
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Spiriva Respimat | Number of Participants With Cardiac Arrhythmias | 11 Participants |
| Leukotriene Receptor Antagonist (LTRA) | Number of Participants With Cardiac Arrhythmias | 17 Participants |
| ICS/LABA Fixed Dose Combination (Switchers) | Number of Participants With Cardiac Arrhythmias | 102 Participants |
| ICS Dose Increase of ICS/LABA Fixed Dose Combination User | Number of Participants With Cardiac Arrhythmias | 16 Participants |
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.
Time frame: On the index date or in the year prior to the index date
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Spiriva Respimat | Number of Participants With Cardiac Failure | NA Patients with cardiac failures |
| Leukotriene Receptor Antagonist (LTRA) | Number of Participants With Cardiac Failure | 9 Patients with cardiac failures |
| ICS/LABA Fixed Dose Combination (Switchers) | Number of Participants With Cardiac Failure | 49 Patients with cardiac failures |
| ICS Dose Increase of ICS/LABA Fixed Dose Combination User | Number of Participants With Cardiac Failure | 12 Patients with cardiac failures |