An observational study in Asthma, sponsored by Boehringer Ingelheim. Completed at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2020-11-03.
Sponsored by Boehringer Ingelheim · Observational
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
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 7,857 is above the median of 150 across 970 observational studies indexed under Asthma.
Browse Asthma studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Asthmatics 6 years and above on ICS/LABA at baselineIMS Pharmetrics (IMS or Database I); EMRClaims+ (Database II)
Exclusion Criteria:
Drug: Tiotropium Respimat® · Drug: Inhaled Corticosteroid/Long-acting beta-agonist
Tiotropium Respimat® 1.25 mcg (on top of baseline 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
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
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
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
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
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
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.
| Milestone | Tiotropium Respimat® (Tio Group) | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) |
|---|---|---|
| Started | 2619 | 5238 |
| Completed | 2619 | 5238 |
| Not completed | 0 | 0 |
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.
| Days | Tiotropium Respimat® (Tio Group) | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) |
|---|---|---|
| Time to First Exacerbation | 340.656 ± 428.061 | 123.151 ± 152.600 |
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).
| Events per 100 person-years | Tiotropium Respimat® (Tio Group) | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) |
|---|---|---|
| At 6 months of follow-up | 41.40 | 116.07 |
| At 1 year of follow-up | 15.65 | 57.24 |
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.
| Events per 100 person-years | Tiotropium Respimat® (Tio Group) | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) |
|---|---|---|
| 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 |
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.
| Score on a scale | Tiotropium Respimat® (Tio Group) | 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 | 77.77 ± 20.16 | 85.69 ± 20.77 |
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.
| Score on a scale | Tiotropium Respimat® (Tio Group) | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) |
|---|---|---|
| Change in Asthma Control Test (ACT) Score at Baseline and in the Follow up Period | 15.65 ± 7.0 | 16.16 ± 5.3 |
Collected over Adverse event information was not applicable for this study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tiotropium Respimat® (Tio Group) | — | — | — |
| Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | — | — | — |
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.
| Age, Continuous(Years) | Tiotropium Respimat® (Tio Group) | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | Total |
|---|---|---|---|
| Mean | 45.12 ± 15.38 | 44.77 ± 15.43 | 44.89 ± 15.41 |
| Sex: Female, Male(Participants) | Tiotropium Respimat® (Tio Group) | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | Total |
|---|---|---|---|
| Female | 1802 | 3576 | 5378 |
| Male | 817 | 1662 | 2479 |
| Race and Ethnicity Not Collected(Participants) | Tiotropium Respimat® (Tio Group) | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https:// trials.boehringer-ingelheim.com/trial_results/ clinical_submission_documents.html to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link http://trials.boehringeringelheim. com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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