Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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: * J41.0 - Simple chronic bronchitis * J41.1 - Mucopurulent chronic bronchitis * J41.8 - Mixed simple and mucopurulent chronic bronchitis * J42 - Unspecified chronic bronchitis * J43.1 - Panlobular emphysema * J43.2 - Centrilobular emphysema * J43.8 - Other emphysema * J43.9 - Emphysema, unspecified * J44.0 - Chronic obstructive pulmonary disease with acute lower respiratory infection * J44.1 - Chronic obstructive pulmonary disease with acute exacerbation, unspecified * J44.8 - Other specified chronic obstructive pulmonary disease * J44.9 - Chronic obstructive pulmonary disease, unspecified
Exclusion criteria
* Patients younger than 40 yeas of age at the time of hospital admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Brazil
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3,015,000 |
| 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. | 1,430 |
| Total | 3,016,430 |
Baseline characteristics
| Characteristic | Patients Diagnosed With COPD, Admitted to the Hospital With Acute Exacerbations |
|---|---|
| Age, Customized 40 to 59 years old | 198 Hospitalizations |
| Age, Customized 60 to 79 years old | 876 Hospitalizations |
| Age, Customized Over 80 years old | 876 Hospitalizations |
| Sex: Female, Male Female | 741 Hospitalizations |
| Sex: Female, Male Male | 689 Hospitalizations |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 52 / 665 | 67 / 765 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tiotropium Treatment - MAT1 | Infirmary Beds | Beds in the general practice and Pulmonology | 883.8 Beds | Standard Deviation 21.2 |
| Tiotropium Treatment - MAT1 | Infirmary Beds | Beds in Adults ICU | 150.7 Beds | Standard Deviation 1.2 |
| Glycopyrronium Treatment - MAT2 | Infirmary Beds | Beds in the general practice and Pulmonology | 895.5 Beds | Standard Deviation 17.7 |
| Glycopyrronium Treatment - MAT2 | Infirmary Beds | Beds in Adults ICU | 146.6 Beds | Standard Deviation 1 |
Comparison: Beds in the general practice and Pulmonology: 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.p-value: 0.11Wilcoxon (Mann-Whitney)
Comparison: 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.p-value: <0.01Wilcoxon (Mann-Whitney)
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tiotropium Treatment - MAT1 | Number of Deaths of Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients | 52 Deaths |
| Glycopyrronium Treatment - MAT2 | Number of Deaths of Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients | 67 Deaths |
Comparison: 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.p-value: 0.37Wilcoxon (Mann-Whitney)
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tiotropium Treatment - MAT1 | Number of Hospital Admissions in Chronic Obstructive Pulmonary Disease (COPD) Patients | 665 Hospitalizations |
| Glycopyrronium Treatment - MAT2 | Number of Hospital Admissions in Chronic Obstructive Pulmonary Disease (COPD) Patients | 765 Hospitalizations |
Comparison: 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.p-value: 0.24Wilcoxon (Mann-Whitney)
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tiotropium Treatment - MAT1 | Total Costs Associated With Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations | 828761.94 Brazilian Reais (R$) |
| Glycopyrronium Treatment - MAT2 | Total Costs Associated With Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations | 1267318.42 Brazilian Reais (R$) |
Comparison: 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.p-value: 0.03Wilcoxon (Mann-Whitney)
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tiotropium Treatment - MAT1 | Number of Hospitalizations With Intensive Care Unit (ICU) Admissions Over Total Number of Hospitalizations | 16 Hospitalizations |
| Glycopyrronium Treatment - MAT2 | Number of Hospitalizations With Intensive Care Unit (ICU) Admissions Over Total Number of Hospitalizations | 37 Hospitalizations |
Comparison: 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.p-value: 0.01Wilcoxon (Mann-Whitney)
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tiotropium Treatment - MAT1 | Total Costs Associated With Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations With Admission to Intensive Care Unit (ICU) | 149145.17 Brazilian Reais (R$) |
| Glycopyrronium Treatment - MAT2 | Total Costs Associated With Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations With Admission to Intensive Care Unit (ICU) | 298051.06 Brazilian Reais (R$) |
Comparison: 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.p-value: 0.07Wilcoxon (Mann-Whitney)