Trial Outcomes & Findings for Morbid Rates After Spiriva Chronic Obstructive Pulmonary Disease (COPD) Protocol Change (NCT NCT06053541)
NCT ID: NCT06053541
Last Updated: 2024-10-26
Results Overview
Number of hospital admissions in Chronic Obstructive Pulmonary Disease (COPD) patients, is reported, the same patient could be hospitalized more than once a year.
COMPLETED
3015000 participants
From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.
2024-10-26
Participant Flow
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.
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.
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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3015000
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Overall Study
COMPLETED
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3015000
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Patients Diagnosed With COPD, Admitted to the Hospital With Acute Exacerbations
n=1430 Hospitalizations
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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Age, Customized
40 to 59 years old
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198 Hospitalizations
n=1430 Hospitalizations
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Age, Customized
60 to 79 years old
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876 Hospitalizations
n=1430 Hospitalizations
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Age, Customized
Over 80 years old
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876 Hospitalizations
n=1430 Hospitalizations
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Sex: Female, Male
Female
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741 Hospitalizations
n=1430 Hospitalizations • 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.
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Sex: Female, Male
Male
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689 Hospitalizations
n=1430 Hospitalizations • 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.
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PRIMARY outcome
Timeframe: From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.Population: 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.
Number of hospital admissions in Chronic Obstructive Pulmonary Disease (COPD) patients, is reported, the same patient could be hospitalized more than once a year.
Outcome measures
| Measure |
Tiotropium Treatment - MAT1
n=665 Hospitalizations
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)) hospitalizations, 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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Glycopyrronium Treatment - MAT2
n=765 Hospitalizations
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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Number of Hospital Admissions in Chronic Obstructive Pulmonary Disease (COPD) Patients
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665 Hospitalizations
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765 Hospitalizations
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PRIMARY outcome
Timeframe: From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.Population: 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.
Number of deaths of hospitalized Chronic Obstructive Pulmonary Disease (COPD) patients, the same patient could be hospitalized more than once a year.
Outcome measures
| Measure |
Tiotropium Treatment - MAT1
n=665 Hospitalizations
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)) hospitalizations, 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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Glycopyrronium Treatment - MAT2
n=765 Hospitalizations
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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Number of Deaths of Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients
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52 Deaths
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67 Deaths
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PRIMARY outcome
Timeframe: From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.Population: 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.
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.
Outcome measures
| Measure |
Tiotropium Treatment - MAT1
n=665 Hospitalizations
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)) hospitalizations, 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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Glycopyrronium Treatment - MAT2
n=765 Hospitalizations
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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Total Costs Associated With Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations
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828761.94 Brazilian Reais (R$)
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1267318.42 Brazilian Reais (R$)
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PRIMARY outcome
Timeframe: From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.Population: 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.
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.
Outcome measures
| Measure |
Tiotropium Treatment - MAT1
n=665 Hospitalizations
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)) hospitalizations, 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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Glycopyrronium Treatment - MAT2
n=765 Hospitalizations
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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Infirmary Beds
Beds in the general practice and Pulmonology
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883.8 Beds
Standard Deviation 21.2
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895.5 Beds
Standard Deviation 17.7
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Infirmary Beds
Beds in Adults ICU
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150.7 Beds
Standard Deviation 1.2
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146.6 Beds
Standard Deviation 1.0
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SECONDARY outcome
Timeframe: From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.Population: 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.
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.
Outcome measures
| Measure |
Tiotropium Treatment - MAT1
n=665 Hospitalization entries
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)) hospitalizations, 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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Glycopyrronium Treatment - MAT2
n=765 Hospitalization entries
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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Number of Hospitalizations With Intensive Care Unit (ICU) Admissions Over Total Number of Hospitalizations
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16 Hospitalizations
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37 Hospitalizations
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SECONDARY outcome
Timeframe: From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.Population: 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.
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.
Outcome measures
| Measure |
Tiotropium Treatment - MAT1
n=16 Hospitalization with ICU admissions
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)) hospitalizations, 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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Glycopyrronium Treatment - MAT2
n=37 Hospitalization with ICU admissions
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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Total Costs Associated With Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations With Admission to Intensive Care Unit (ICU)
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149145.17 Brazilian Reais (R$)
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298051.06 Brazilian Reais (R$)
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Adverse Events
Tiotropium Treatment - MAT1
Glycopyrronium Treatment - MAT2
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place