Trial · NCT03964220
Impact of Tiotropium Add-on Therapy in Patients With Asthma
NCT03964220, Completed, Boehringer Ingelheim; results first posted 2020-10-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Impact of Tiotropium Add-on Therapy in Patients With Asthma. Trials, record NCT03964220. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03964220
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Impact of Tiotropium Add-on Therapy in Patients With Asthma
- NCT number
- NCT03964220
- Status
- Completed
- Enrollment
- 7,857 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Asthma
- Interventions
- Tiotropium Respimat®, Inhaled Corticosteroid/Long-acting beta-agonist
- First posted
- 2019-05-28
- Last updated
- 2020-11-03
- Results first posted
- 2020-10-12
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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). |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to First Exacerbation | From baseline until end of follow-up, up to 3 years | 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. | Days | MEAN |
| SECONDARY | Rate of Exacerbation at 6 Months and 1 Year of Follow-up | At 6 month and 1 year of follow-up | 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. | Events per 100 person-years | NUMBER |
| SECONDARY | Health Care Resource Utilization (HCRU) During Follow-up | During follow-up period, From baseline until end of follow-up, up to 3 years | 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. | Events per 100 person-years | NUMBER |
| SECONDARY | 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 | 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. | Score on a scale | MEAN |
| SECONDARY | 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 | 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. | Score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to First Exacerbation | Tiotropium Respimat® (Tio Group) | 340.656 | Standard Deviation 428.061 | Days | |
| Time to First Exacerbation | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | 123.151 | Standard Deviation 152.600 | Days | |
| Rate of Exacerbation at 6 Months and 1 Year of Follow-up | Tiotropium Respimat® (Tio Group) | At 6 months of follow-up | 41.40 | Events per 100 person-years | |
| Rate of Exacerbation at 6 Months and 1 Year of Follow-up | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | At 6 months of follow-up | 116.07 | Events per 100 person-years | |
| Rate of Exacerbation at 6 Months and 1 Year of Follow-up | Tiotropium Respimat® (Tio Group) | At 1 year of follow-up | 15.65 | Events per 100 person-years | |
| Rate of Exacerbation at 6 Months and 1 Year of Follow-up | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | At 1 year of follow-up | 57.24 | Events per 100 person-years | |
| Health Care Resource Utilization (HCRU) During Follow-up | Tiotropium Respimat® (Tio Group) | Hospitalization (all cause) | 23.97 | Events per 100 person-years | |
| Health Care Resource Utilization (HCRU) During Follow-up | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | Hospitalization (all cause) | 46.51 | Events per 100 person-years | |
| Health Care Resource Utilization (HCRU) During Follow-up | Tiotropium Respimat® (Tio Group) | Hospitalization (asthma related) | 4.89 | Events per 100 person-years | |
| Health Care Resource Utilization (HCRU) During Follow-up | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | Hospitalization (asthma related) | 20.27 | Events per 100 person-years |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tiotropium Respimat® (Tio Group) | 2,619 | |
| Overall Study | STARTED | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | 5,238 | |
| Overall Study | COMPLETED | Tiotropium Respimat® (Tio Group) | 2,619 | |
| Overall Study | COMPLETED | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | 5,238 | |
| Overall Study | NOT COMPLETED | Tiotropium Respimat® (Tio Group) | 0 | |
| Overall Study | NOT COMPLETED | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tiotropium Respimat® (Tio Group) | 0 | 0 |
| Total, all-cause mortality | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | 0 | 0 |
| Total, other adverse events | Tiotropium Respimat® (Tio Group) | 0 | 0 |
| Total, other adverse events | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | 0 | 0 |
| Total, serious adverse events | Tiotropium Respimat® (Tio Group) | 0 | 0 |
| Total, serious adverse events | Inhaled Corticosteroid/Long-acting Beta-agonist (NonTio Group) | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03964220
GET https://conductscience.org/api/trials/v1/NCT03964220/results?page=2