Asthma
Conditions
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
Interventions
Tiotropium Respimat® 1.25 mcg (on top of baseline Inhaled Corticosteroid/Long-acting beta-agonist )
DRUGInhaled 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
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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)). | 2,619 |
| 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)). | 5,238 |
| Total | 7,857 |
Baseline characteristics
| Characteristic | Tiotropium Respimat® (Tio Group) | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | Total |
|---|---|---|---|
| Age, Continuous | 45.12 Years STANDARD_DEVIATION 15.38 | 44.77 Years STANDARD_DEVIATION 15.43 | 44.89 Years STANDARD_DEVIATION 15.41 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 1802 Participants | 3576 Participants | 5378 Participants |
| Sex: Female, Male Male | 817 Participants | 1662 Participants | 2479 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: From baseline until end of follow-up, up to 3 years
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium Respimat® (Tio Group) | Time to First Exacerbation | 340.656 Days | Standard Deviation 428.061 |
| Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | Time to First Exacerbation | 123.151 Days | Standard Deviation 152.6 |
Comparison: 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.p-value: 0.04495% CI: [0.427, 0.99]Regression, Cox
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.
Time frame: From baseline until end of follow-up, up to 3 years
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium Respimat® (Tio Group) | Change in Asthma Control Test (ACT) Score at Baseline and in the Follow up Period | 15.65 Score on a scale | Standard Deviation 7 |
| Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | Change in Asthma Control Test (ACT) Score at Baseline and in the Follow up Period | 16.16 Score on a scale | Standard Deviation 5.3 |
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.
Time frame: From baseline until end of follow-up, up to 3 years
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium Respimat® (Tio Group) | Change in Lung Function (Forced Expiratory Volume in 1 Second (FEV1) Score) at Baseline and Follow up Period | 77.77 Score on a scale | Standard Deviation 20.16 |
| Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | Change in Lung Function (Forced Expiratory Volume in 1 Second (FEV1) Score) at Baseline and Follow up Period | 85.69 Score on a scale | Standard Deviation 20.77 |
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.
Time frame: During follow-up period, From baseline until end of follow-up, up to 3 years
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tiotropium Respimat® (Tio Group) | Health Care Resource Utilization (HCRU) During Follow-up | Hospitalization (all cause) | 23.97 Events per 100 person-years |
| Tiotropium Respimat® (Tio Group) | Health Care Resource Utilization (HCRU) During Follow-up | Hospitalization (asthma related) | 4.89 Events per 100 person-years |
| Tiotropium Respimat® (Tio Group) | Health Care Resource Utilization (HCRU) During Follow-up | Emergency room (ER) visit (all cause) | 45.00 Events per 100 person-years |
| Tiotropium Respimat® (Tio Group) | Health Care Resource Utilization (HCRU) During Follow-up | ER visit (asthma related) | 12.23 Events per 100 person-years |
| Tiotropium Respimat® (Tio Group) | Health Care Resource Utilization (HCRU) During Follow-up | Outpatient (OP) visit (all cause) | 206.92 Events per 100 person-years |
| Tiotropium Respimat® (Tio Group) | Health Care Resource Utilization (HCRU) During Follow-up | OP visit (asthma related) | 133.06 Events per 100 person-years |
| Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | Health Care Resource Utilization (HCRU) During Follow-up | Outpatient (OP) visit (all cause) | 232.55 Events per 100 person-years |
| Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | Health Care Resource Utilization (HCRU) During Follow-up | Hospitalization (all cause) | 46.51 Events per 100 person-years |
| Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | Health Care Resource Utilization (HCRU) During Follow-up | ER visit (asthma related) | 47.70 Events per 100 person-years |
| Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | Health Care Resource Utilization (HCRU) During Follow-up | Hospitalization (asthma related) | 20.27 Events per 100 person-years |
| Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | Health Care Resource Utilization (HCRU) During Follow-up | OP visit (asthma related) | 158.61 Events per 100 person-years |
| Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | Health Care Resource Utilization (HCRU) During Follow-up | Emergency room (ER) visit (all cause) | 84.67 Events per 100 person-years |
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).
Time frame: At 6 month and 1 year of follow-up
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tiotropium Respimat® (Tio Group) | Rate of Exacerbation at 6 Months and 1 Year of Follow-up | At 6 months of follow-up | 41.40 Events per 100 person-years |
| Tiotropium Respimat® (Tio Group) | Rate of Exacerbation at 6 Months and 1 Year of Follow-up | At 1 year of follow-up | 15.65 Events per 100 person-years |
| Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | Rate of Exacerbation at 6 Months and 1 Year of Follow-up | At 6 months of follow-up | 116.07 Events per 100 person-years |
| Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | Rate of Exacerbation at 6 Months and 1 Year of Follow-up | At 1 year of follow-up | 57.24 Events per 100 person-years |
Comparison: Analysis for the rate of exacerbation between Tio and NonTio groups within 6 months of follow-up.p-value: <0.0001Negative binomial regression
Comparison: Analysis for the rate of exacerbation between Tio and NonTio groups within 1 year of follow-up.p-value: <0.0001Negative binomial regression