Trial · NCT06053541
Morbid Rates After Spiriva Chronic Obstructive Pulmonary Disease (COPD) Protocol Change
NCT06053541, Completed, Boehringer Ingelheim; results first posted 2024-10-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Morbid Rates After Spiriva Chronic Obstructive Pulmonary Disease (COPD) Protocol Change. Trials, record NCT06053541. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06053541
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Morbid Rates After Spiriva Chronic Obstructive Pulmonary Disease (COPD) Protocol Change
- NCT number
- NCT06053541
- Status
- Completed
- Enrollment
- 3,015,000 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Pulmonary Disease, Chronic Obstructive
- First posted
- 2023-09-25
- Last updated
- 2024-10-26
- Results first posted
- 2024-10-26
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Hospital Admissions in Chronic Obstructive Pulmonary Disease (COPD) Patients | From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year. | Number of hospital admissions in Chronic Obstructive Pulmonary Disease (COPD) patients, is reported, the same patient could be hospitalized more than once a year. |
| Primary | Number of Deaths of Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients | From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year. | Number of deaths of hospitalized Chronic Obstructive Pulmonary Disease (COPD) patients, the same patient could be hospitalized more than once a year. |
| Primary | Total Costs Associated With Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations | From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year. | Total accumulated costs to the payer per year associated with Chronic Obstructive Pulmonary Disease (COPD) hospitalizations, is reported, the same patient could have been hospitalized more than once a year. No individual costs, the cost reported are the total spent per year. |
| Primary | Infirmary Beds | From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year. | Average monthly number of available Infirmary beds, including available general and ICU (Intensive care unit) beds are reported, the same patient could have been hospitalized more than once a year. |
| Secondary | Number of Hospitalizations With Intensive Care Unit (ICU) Admissions Over Total Number of Hospitalizations | From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year. | Number of hospitalizations with intensive care unit (ICU) admissions over total number of hospitalizations, is reported, the same patient could have been hospitalized more than once a year. |
| Secondary | Total Costs Associated With Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations With Admission to Intensive Care Unit (ICU) | From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year. | Total costs associated with Chronic Obstructive Pulmonary Disease (COPD) hospitalizations with admission to intensive care unit (ICU) , is reported, the same patient could have been hospitalized more than once a year. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Hospital Admissions in Chronic Obstructive Pulmonary Disease (COPD) Patients | From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year. | Patients with Chronic Obstructive Pulmonary Disease (COPD) defined by the Health State Secretariat of Federal District in Brazil who were hospitalized between August 2017 and July 2019. Federal District 2019 population was 3015000 according to the Brazilian Institute of Geography and Statistics. | Hospitalizations | NUMBER |
| PRIMARY | Number of Deaths of Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients | From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year. | Patients with Chronic Obstructive Pulmonary Disease (COPD) defined by the Health State Secretariat of Federal District in Brazil who were hospitalized between August 2017 and July 2019. Federal District 2019 population was 3015000 according to the Brazilian Institute of Geography and Statistics. | Deaths | NUMBER |
| PRIMARY | Total Costs Associated With Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations | From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year. | Patients with Chronic Obstructive Pulmonary Disease (COPD) defined by the Health State Secretariat of Federal District in Brazil who were hospitalized between August 2017 and July 2019. Federal District 2019 population was 3015000 according to the Brazilian Institute of Geography and Statistics. | Brazilian Reais (R$) | NUMBER |
| PRIMARY | Infirmary Beds | From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year. | Patients with Chronic Obstructive Pulmonary Disease (COPD) defined by the Health State Secretariat of Federal District in Brazil who were hospitalized between August 2017 and July 2019. Federal District 2019 population was 3015000 according to the Brazilian Institute of Geography and Statistics. | Beds | MEAN |
| SECONDARY | Number of Hospitalizations With Intensive Care Unit (ICU) Admissions Over Total Number of Hospitalizations | From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year. | Patients with Chronic Obstructive Pulmonary Disease (COPD) defined by the Health State Secretariat of Distrito Federal (DF) in Brazil who were hospitalized between August 2017 and July 2019. The Federal District 2019 population was 3015000 according to the Brazilian Institute of Geography and Statistics. | Hospitalizations | NUMBER |
| SECONDARY | Total Costs Associated With Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations With Admission to Intensive Care Unit (ICU) | From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year. | Patients with Chronic Obstructive Pulmonary Disease (COPD) defined by the Health State Secretariat of Distrito Federal (DF) in Brazil who were hospitalized between August 2017 and July 2019. Patient hospitalizations with intensive care unit (ICU) admissions were analyzed. The Federal District 2019 population was 3015000 according to the Brazilian Institute of Geography and Statistics. | Brazilian Reais (R$) | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Hospital Admissions in Chronic Obstructive Pulmonary Disease (COPD) Patients | Tiotropium Treatment - MAT1 | 665 | Hospitalizations | ||
| Number of Hospital Admissions in Chronic Obstructive Pulmonary Disease (COPD) Patients | Glycopyrronium Treatment - MAT2 | 765 | Hospitalizations | ||
| Number of Deaths of Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients | Tiotropium Treatment - MAT1 | 52 | Deaths | ||
| Number of Deaths of Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients | Glycopyrronium Treatment - MAT2 | 67 | Deaths | ||
| Total Costs Associated With Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations | Tiotropium Treatment - MAT1 | 828761.94 | Brazilian Reais (R$) | ||
| Total Costs Associated With Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations | Glycopyrronium Treatment - MAT2 | 1267318.42 | Brazilian Reais (R$) | ||
| Infirmary Beds | Tiotropium Treatment - MAT1 | Beds in the general practice and Pulmonology | 883.8 | Standard Deviation 21.2 | Beds |
| Infirmary Beds | Glycopyrronium Treatment - MAT2 | Beds in the general practice and Pulmonology | 895.5 | Standard Deviation 17.7 | Beds |
| Infirmary Beds | Tiotropium Treatment - MAT1 | Beds in Adults ICU | 150.7 | Standard Deviation 1.2 | Beds |
| Infirmary Beds | Glycopyrronium Treatment - MAT2 | Beds in Adults ICU | 146.6 | Standard Deviation 1.0 | Beds |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Patients Diagnosed With COPD, Admitted to the Hospital With Acute Exacerbations | 3,015,000 | |
| Overall Study | COMPLETED | Patients Diagnosed With COPD, Admitted to the Hospital With Acute Exacerbations | 3,015,000 | |
| Overall Study | NOT COMPLETED | Patients Diagnosed With COPD, Admitted to the Hospital With Acute Exacerbations | 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 Treatment - MAT1 | 52 | 665 |
| Total, all-cause mortality | Glycopyrronium Treatment - MAT2 | 67 | 765 |
| Total, other adverse events | Tiotropium Treatment - MAT1 | 0 | 0 |
| Total, other adverse events | Glycopyrronium Treatment - MAT2 | 0 | 0 |
| Total, serious adverse events | Tiotropium Treatment - MAT1 | 0 | 0 |
| Total, serious adverse events | Glycopyrronium Treatment - MAT2 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Tiotropium Treatment - MAT1 vs Glycopyrronium Treatment - MAT2: deaths from any cause |
Source Trial comparisons
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/NCT06053541
GET https://conductscience.org/api/trials/v1/NCT06053541/registered