Trial Outcomes & Findings for Characteristics of Pts Initiating Spiriva Respimat in Asthma (NCT NCT03692676)
NCT ID: NCT03692676
Last Updated: 2025-04-17
Results Overview
The number of participants who had Cardiac arrhythmias on the index date or in the year prior to the index date.
Recruitment status
COMPLETED
Target enrollment
116133 participants
Primary outcome timeframe
On the index date or in the year prior to the index date
Results posted on
2025-04-17
Participant Flow
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).
All subjects were screened for eligibility to participate in trial. Subjects meeting the exclusion criteria were excluded.
Participant milestones
| Measure |
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)
|
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)
|
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)
|
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)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10365
|
51142
|
49479
|
5147
|
|
Overall Study
COMPLETED
|
940
|
3704
|
11135
|
1561
|
|
Overall Study
NOT COMPLETED
|
9425
|
47438
|
38344
|
3586
|
Reasons for withdrawal
| Measure |
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)
|
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)
|
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)
|
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)
|
|---|---|---|---|---|
|
Overall Study
exclude patients with prior use
|
4424
|
24726
|
0
|
0
|
|
Overall Study
exclude patients without concurrent ICS/LABA FDC use
|
2480
|
19037
|
0
|
0
|
|
Overall Study
exclude patients without prior recorded asthma diagnosis
|
881
|
563
|
6281
|
558
|
|
Overall Study
exclude patients less than 18 years of age on index date
|
8
|
613
|
836
|
193
|
|
Overall Study
exclude patients with less than 1 year prior continous UTS enrollment
|
149
|
717
|
1723
|
273
|
|
Overall Study
exclude patients with prior LAMA use (any time prior to index date)
|
1208
|
759
|
7419
|
684
|
|
Overall Study
exclude patients with prior recorded COPD diagnosis
|
275
|
218
|
1515
|
173
|
|
Overall Study
exclude patients with multiple FDC prescriptions on index date
|
0
|
0
|
1147
|
4
|
|
Overall Study
exclude patients with prior use of same substances and device
|
0
|
0
|
3700
|
0
|
|
Overall Study
exclude patients without ICS/LABA FDC prescription within 3 months prior to index date
|
0
|
0
|
14965
|
1198
|
|
Overall Study
exclude patients with different substance(s)/device at preceding prescription
|
0
|
0
|
0
|
223
|
|
Overall Study
Other
|
0
|
805
|
758
|
277
|
|
Overall Study
exclude patients with multiple substance(s)/device at preceding prescription
|
0
|
0
|
0
|
3
|
Baseline Characteristics
Characteristics of Pts Initiating Spiriva Respimat in Asthma
Baseline characteristics by cohort
| Measure |
Spiriva Respimat
n=940 Participants
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)
|
Leukotriene Receptor Antagonist (LTRA)
n=3704 Participants
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)
|
ICS/LABA Fixed Dose Combination (Switchers)
n=11135 Participants
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)
|
ICS Dose Increase of ICS/LABA Fixed Dose Combination User
n=1561 Participants
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)
|
Total
n=17340 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54.22 Year
STANDARD_DEVIATION 15.741 • n=5 Participants
|
49.12 Year
STANDARD_DEVIATION 16.299 • n=7 Participants
|
53.31 Year
STANDARD_DEVIATION 16.961 • n=5 Participants
|
51.91 Year
STANDARD_DEVIATION 17.189 • n=4 Participants
|
52.34 Year
STANDARD_DEVIATION 16.77 • n=21 Participants
|
|
Sex: Female, Male
Female
|
653 Participants
n=5 Participants
|
2479 Participants
n=7 Participants
|
7121 Participants
n=5 Participants
|
979 Participants
n=4 Participants
|
11232 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
287 Participants
n=5 Participants
|
1225 Participants
n=7 Participants
|
4014 Participants
n=5 Participants
|
582 Participants
n=4 Participants
|
6108 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
25 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
367 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
119 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
527 Participants
n=5 Participants
|
1996 Participants
n=7 Participants
|
5896 Participants
n=5 Participants
|
776 Participants
n=4 Participants
|
9195 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
13 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
166 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
366 Participants
n=5 Participants
|
1548 Participants
n=7 Participants
|
4859 Participants
n=5 Participants
|
720 Participants
n=4 Participants
|
7493 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: On the index date or in the year prior to the index datePopulation: 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).
The number of participants who had Cardiac arrhythmias on the index date or in the year prior to the index date.
Outcome measures
| Measure |
Spiriva Respimat
n=940 Participants
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)
|
Leukotriene Receptor Antagonist (LTRA)
n=3704 Participants
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)
|
ICS/LABA Fixed Dose Combination (Switchers)
n=11135 Participants
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)
|
ICS Dose Increase of ICS/LABA Fixed Dose Combination User
n=1561 Participants
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)
|
|---|---|---|---|---|
|
Number of Participants With Cardiac Arrhythmias
|
11 Participants
|
17 Participants
|
102 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: On the index date or in the year prior to the index datePopulation: 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).
The number of participants who had Cardiac failure on the index date or in the year prior to the index date.
Outcome measures
| Measure |
Spiriva Respimat
n=940 Participants
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)
|
Leukotriene Receptor Antagonist (LTRA)
n=3704 Participants
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)
|
ICS/LABA Fixed Dose Combination (Switchers)
n=11135 Participants
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)
|
ICS Dose Increase of ICS/LABA Fixed Dose Combination User
n=1561 Participants
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)
|
|---|---|---|---|---|
|
Number of Participants With Cardiac Failure
|
NA Patients with cardiac failures
NA = \<5, for compliance with Independent Scientific Advisory Committee (ISAC) requirements, any covariate resulting in counts less than 5 will be reported as "\<5" without any further reporting.
|
9 Patients with cardiac failures
|
49 Patients with cardiac failures
|
12 Patients with cardiac failures
|
Adverse Events
Spiriva Respimat
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Leukotriene Receptor Antagonist (LTRA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ICS/LABA Fixed Dose Combination (Switchers)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ICS Dose Increase of ICS/LABA Fixed Dose Combination User
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER