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This study evaluates hospitalizations and mortality in patients with Chronic Obstructive Pulmonary Disease (COPD) before and after the implantation of a new COPD treatment plan (replacement of tiotropium soft mist inhaler for glycopyrronium dry powder inhaler) by the Health State Secretariat of Federal District in Brazil.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients diagnosed with COPD, admitted to the hospital with acute exacerbations | Patients over 40 years of age, diagnosed with Chronic Obstructive Pulmonary Disease (COPD), admitted to the hospital with acute exacerbations as recorded in the DATASUS (Unified Health Brazilian System Informatics Department (in Portuguese) between August 2017 and July 2019. Patients were treated with either Tiotropium bromide in soft mist inhaler (SPIRIVA® RESPIMAT®) or with Glycopyrronium bromide in dry powder inhaler (Seebri® Breezhaler®) as part of the treatment plan for Chronic Obstructive Pulmonary Disease (COPD) defined by the Health State Secretariat of Distrito Federal (DF) in Brazil. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Hospital Admissions in Chronic Obstructive Pulmonary Disease (COPD) Patients | Number of hospital admissions in Chronic Obstructive Pulmonary Disease (COPD) patients, is reported, the same patient could be hospitalized more than once a year. | 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 | Number of deaths of hospitalized Chronic Obstructive Pulmonary Disease (COPD) patients, the same patient could be hospitalized more than once a year. | 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 | 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. | From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year. |
| Infirmary Beds | 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. | From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Hospitalizations With Intensive Care Unit (ICU) Admissions Over Total Number of Hospitalizations | 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. | From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year. |
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Inclusion Criteria:
Patients older than 40 years of age at the time of hospital admission
Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to the International Statistical Classification of Diseases and Related Health Problems Version 10 (ICD-10) established by the Health Care Protocol of the Health Secretariat of Federal District (SES/DF), with the following codes:
Exclusion Criteria:
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Patients over 40 years of age, diagnosed with Chronic Obstructive Pulmonary Disease (COPD), admitted to the hospital with acute exacerbations of the disease between August 2017 and July 2019 in Federal District, Brazil.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Brasil | São Paulo | 04794-000 | Brazil |
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| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to:
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The SUS data was not individualized, this study had access to the total number of hospitalizations and not to the exact number of patients as the same patient could be hospitalized more than once a year.
This was an observational study based on existing data from the Brazilian Public Healthcare System (SUS) to investigate the potential different patterns on chronic obstructive pulmonary disease (COPD) mortality, hospitalizations, ICU usage rates and costs after the COPD protocol change in Distrito Federal (DF), Brazil, in August 2018, with a substitution of tiotropium in soft mist inhaler to glycopyrronium in dry powder inhaler.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Diagnosed With COPD, Admitted to the Hospital With Acute Exacerbations | Patients over 40 years of age, diagnosed with Chronic Obstructive Pulmonary Disease (COPD), admitted to the hospital with acute exacerbations as recorded in the DATASUS (Unified Health Brazilian System Informatics Department (in Portuguese) between August 2017 and July 2019. Patients were treated with either Tiotropium bromide in soft mist inhaler (SPIRIVA® RESPIMAT®) or with Glycopyrronium bromide in dry powder inhaler (Seebri® Breezhaler®) as part of the treatment plan for Chronic Obstructive Pulmonary Disease (COPD) defined by the Health State Secretariat of Distrito Federal (DF) in Brazil. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
| ID | Title | Description |
|---|---|---|
| BG000 | Patients Diagnosed With COPD, Admitted to the Hospital With Acute Exacerbations | Patients over 40 years of age, diagnosed with Chronic Obstructive Pulmonary Disease (COPD), admitted to the hospital with acute exacerbations as recorded in the DATASUS (Unified Health Brazilian System Informatics Department (in Portuguese) between August 2017 and July 2019. Patients were treated with either Tiotropium bromide in soft mist inhaler (SPIRIVA® RESPIMAT®) or with Glycopyrronium bromide in dry powder inhaler (Seebri® Breezhaler®) as part of the treatment plan for Chronic Obstructive Pulmonary Disease (COPD) defined by the Health State Secretariat of Distrito Federal (DF) in Brazil. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Units |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Hospital Admissions in Chronic Obstructive Pulmonary Disease (COPD) Patients | Number of hospital admissions in Chronic Obstructive Pulmonary Disease (COPD) patients, is reported, the same patient could be hospitalized more than once a 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. | Posted | Number | 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. | Hospitalizations | Hospitalizations |
|
Not applicable for other Adverse Events (AEs) and serious AEs. All-Cause mortality was recorded for any hospitalization between August 2017 and July 2019, up to 2 years.
This is a study with secondary use of data, safety reporting on an individual case level is not applicable. This study had access to the number of hospitalizations and not to the exact number of patients. Other Adverse Events (AEs) and Serious AEs were not collected. "0" total Number of Participants at Risk means not collected. All-cause mortality was reported based on the number of hospitalizations, the corresponding number at risk indicates the total number of hospitalizations recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tiotropium Treatment - MAT1 | In the MAT1 (total arithmetic mean 1) period, August 2017 to July 2018 data cut available in the DATASUS (Unified Health Brazilian System Informatics Department (in Portuguese)), patients received Tiotropium bromide in soft mist inhaler (SPIRIVA® RESPIMAT®) as part of the treatment plan for Chronic Obstructive Pulmonary Disease (COPD) defined by the Health State Secretariat of Distrito Federal (DF) in Brazil. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 28, 2021 | Jul 2, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Total Costs Associated With Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations With Admission to Intensive Care Unit (ICU) | 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. | From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year. |
| Hospitalizations |
|
| Hospitalizations |
| Hospitalizations |
|
|
| Sex: Female, Male | Sex is reported per patient hospitalization entry | Sex is reported per patient hospitalization entry, as the SUS data was not individualized, this study had access to the total number of hospitalizations and not to the exact number of patients, the same patient could be hospitalized more than once a year. | Count of Units | Hospitalizations | Hospitalizations |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| OG001 | Glycopyrronium Treatment - MAT2 | In the MAT2 (total arithmetic mean 2) period, August 2018 to July 2019 data cut available in the DATASUS (Unified Health Brazilian System Informatics Department (in Portuguese) hospitalizations, patients received Glycopyrronium bromide in dry powder inhaler (Seebri® Breezhaler®) as part of the treatment plan for Chronic Obstructive Pulmonary Disease (COPD) defined by the Health State Secretariat of Distrito Federal (DF) in Brazil. |
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|
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| Primary | Number of Deaths of Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients | Number of deaths of hospitalized Chronic Obstructive Pulmonary Disease (COPD) patients, the same patient could be hospitalized more than once a 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. | Posted | Number | Deaths | From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year. | Hospitalizations | Hospitalizations |
|
|
|
|
| Primary | Total Costs Associated With Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations | 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. | 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. | Posted | Number | Brazilian Reais (R$) | From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year. | Hospitalizations | Hospitalizations |
|
|
|
|
| Primary | Infirmary Beds | 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. | 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. | Posted | Mean | Standard Deviation | 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. | Hospitalizations | Hospitalizations |
|
|
|
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| Secondary | Number of Hospitalizations With Intensive Care Unit (ICU) Admissions Over Total Number of Hospitalizations | 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. | 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. | Posted | Number | 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. | Hospitalization entries | Hospitalization entries |
|
|
|
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| Secondary | Total Costs Associated With Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations With Admission to Intensive Care Unit (ICU) | 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. | 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. | Posted | Number | Brazilian Reais (R$) | From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year. | Hospitalization with ICU admissions | Hospitalization with ICU admissions |
|
|
|
|
| 52 |
| 665 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Glycopyrronium Treatment - MAT2 | In the MAT2 (total arithmetic mean 2) period, August 2018 to July 2019 data cut available in the DATASUS (Unified Health Brazilian System Informatics Department (in Portuguese), patients received Glycopyrronium bromide in dry powder inhaler (Seebri® Breezhaler®) as part of the treatment plan for Chronic Obstructive Pulmonary Disease (COPD) defined by the Health State Secretariat of Distrito Federal (DF) in Brazil. | 67 | 765 | 0 | 0 | 0 | 0 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| Beds in Adults ICU |
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Beds in Adults ICU: For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value < 0.05 was considered.
| Wilcoxon (Mann-Whitney) |
| <0.01 |
| Other |