Impact of Tiotropium Add-on Therapy in Patients With Asthma
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT03964220
Collaborator
(none)
7,857
1
6.2
1265.3
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
7857 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
The Effectiveness of Tiotropium Add-on Therapy Using a Real-world Cohort of Patients With Asthma
Actual Study Start Date
:
Mar 15, 2019
Actual Primary Completion Date
:
Sep 20, 2019
Actual Study Completion Date
:
Sep 20, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with Asthma
|
Drug: Tiotropium Respimat®
Tiotropium Respimat® 1.25 mcg (on top of baseline Inhaled Corticosteroid/Long-acting beta-agonist )
Drug: Inhaled Corticosteroid/Long-acting beta-agonist
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
|
Outcome Measures
Primary Outcome Measures
- Time to First Exacerbation [From baseline until end of follow-up, up to 3 years]
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.
Secondary Outcome Measures
- Rate of Exacerbation at 6 Months and 1 Year of Follow-up [At 6 month 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).
- Health Care Resource Utilization (HCRU) During Follow-up [During follow-up period, From baseline until end of follow-up, up to 3 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) and up to 3 years of study period.
- Change in Lung Function (Forced Expiratory Volume in 1 Second (FEV1) Score) at Baseline and Follow up Period [From baseline until end of follow-up, up to 3 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) 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.
- Change in Asthma Control Test (ACT) Score at Baseline and in the Follow up Period [From baseline until end of follow-up, up to 3 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) 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
12 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients with least one asthma diagnosis in the inpatient setting or at least two separate instances of asthma diagnosis (separated by at least 30 days) recorded in the outpatient or emergency room setting will be included.
-
Patients will be required to be already on Inhaled Corticosteroid/Long-acting beta-agonist (ICS/LABA).
-
Patients will be required to have available records 12 months prior to the index date.
Exclusion Criteria:
-
Patients below the age of 6 years on the Inhaled Corticosteroid/Long-acting beta-agonist initiation (ICS/LABAi) date will be excluded.
-
Patients with a diagnosis of COPD at any time during the study period will be excluded.
-
Those who are on biologics at baseline will be removed.
-
After the PSM process, unmatched patients will be excluded.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | eMax Health | White Plains | New York | United States | 10601 |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
None specified.Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT03964220
Other Study ID Numbers:
- 0205-0543
First Posted:
May 28, 2019
Last Update Posted:
Nov 3, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 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. |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Tiotropium Respimat® (Tio Group) | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) |
|---|---|---|
| Arm/Group Description | 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)). | 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)). |
| Period Title: Overall Study | ||
| STARTED | 2619 | 5238 |
| COMPLETED | 2619 | 5238 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Tiotropium Respimat® (Tio Group) | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | Total |
|---|---|---|---|
| Arm/Group Description | 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)). | 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)). | Total of all reporting groups |
| Overall Participants | 2619 | 5238 | 7857 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
45.12
(15.38)
|
44.77
(15.43)
|
44.89
(15.41)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
1802
68.8%
|
3576
68.3%
|
5378
68.4%
|
| Male |
817
31.2%
|
1662
31.7%
|
2479
31.6%
|
| Race and Ethnicity Not Collected (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
||
Outcome Measures
| Title | Time to First Exacerbation |
|---|---|
| Description | 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. |
| Time Frame | From baseline until end of follow-up, up to 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Tiotropium Respimat® (Tio Group) | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) |
|---|---|---|
| Arm/Group Description | 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)). | 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)). |
| Measure Participants | 2619 | 5238 |
| Mean (Standard Deviation) [Days] |
340.656
(428.061)
|
123.151
(152.600)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Tiotropium Respimat® (Tio Group), Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) |
|---|---|---|
| Comments | The time to first exacerbation was analysis using Cox Proportional Hazards model with group status as the only independent variable assessing the risk of exacerbation across Tio and NonTio groups. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.044 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.65 | |
| Confidence Interval |
(2-Sided) 95% 0.427 to 0.990 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Rate of Exacerbation at 6 Months and 1 Year of Follow-up |
|---|---|
| Description | 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). |
| Time Frame | At 6 month and 1 year of follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Tiotropium Respimat® (Tio Group) | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) |
|---|---|---|
| Arm/Group Description | 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)). | 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)). |
| Measure Participants | 2619 | 5238 |
| At 6 months of follow-up |
41.40
|
116.07
|
| At 1 year of follow-up |
15.65
|
57.24
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Tiotropium Respimat® (Tio Group), Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) |
|---|---|---|
| Comments | Analysis for the rate of exacerbation between Tio and NonTio groups within 6 months of follow-up. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.0001 |
| Comments | ||
| Method | Negative binomial regression | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tiotropium Respimat® (Tio Group), Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) |
|---|---|---|
| Comments | Analysis for the rate of exacerbation between Tio and NonTio groups within 1 year of follow-up. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.0001 |
| Comments | ||
| Method | Negative binomial regression | |
| Comments | ||
| Title | Health Care Resource Utilization (HCRU) During Follow-up |
|---|---|
| Description | 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. |
| Time Frame | During follow-up period, From baseline until end of follow-up, up to 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Tiotropium Respimat® (Tio Group) | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) |
|---|---|---|
| Arm/Group Description | 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)). | 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)). |
| Measure Participants | 2619 | 5238 |
| Hospitalization (all cause) |
23.97
|
46.51
|
| Hospitalization (asthma related) |
4.89
|
20.27
|
| Emergency room (ER) visit (all cause) |
45.00
|
84.67
|
| ER visit (asthma related) |
12.23
|
47.70
|
| Outpatient (OP) visit (all cause) |
206.92
|
232.55
|
| OP visit (asthma related) |
133.06
|
158.61
|
| Title | Change in Lung Function (Forced Expiratory Volume in 1 Second (FEV1) Score) at Baseline and Follow up Period |
|---|---|
| Description | 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. |
| Time Frame | From baseline until end of follow-up, up to 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Tiotropium Respimat® (Tio Group) | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) |
|---|---|---|
| Arm/Group Description | 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)). | 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)). |
| Measure Participants | 13 | 26 |
| Mean (Standard Deviation) [Score on a scale] |
77.77
(20.16)
|
85.69
(20.77)
|
| Title | Change in Asthma Control Test (ACT) Score at Baseline and in the Follow up Period |
|---|---|
| Description | 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. |
| Time Frame | From baseline until end of follow-up, up to 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Tiotropium Respimat® (Tio Group) | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) |
|---|---|---|
| Arm/Group Description | 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)). | 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)). |
| Measure Participants | 23 | 31 |
| Mean (Standard Deviation) [Score on a scale] |
15.65
(7.0)
|
16.16
(5.3)
|
Adverse Events
| Time Frame | Adverse event information was not applicable for this study | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | 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. | |||
| Arm/Group Title | Tiotropium Respimat® (Tio Group) | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | ||
| Arm/Group Description | 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)). | 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)). | ||
All Cause Mortality |
||||
| Tiotropium Respimat® (Tio Group) | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | ||
Serious Adverse Events |
||||
| Tiotropium Respimat® (Tio Group) | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | ||
Other (Not Including Serious) Adverse Events |
||||
| Tiotropium Respimat® (Tio Group) | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Boehringer Ingelheim Call Center |
|---|---|
| Organization | Boehringer Ingelheim |
| Phone | 1-800-243-0127 |
| clintriage.rdg@boehringer-ingelheim.com |
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT03964220
Other Study ID Numbers:
- 0205-0543
First Posted:
May 28, 2019
Last Update Posted:
Nov 3, 2020
Last Verified:
Oct 1, 2020