Morbid Rates After Spiriva Chronic Obstructive Pulmonary Disease (COPD) Protocol Change

Study Overview
=================
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.

Official Title
-----------------
Hospitalization, Mortality Rates and Costs Associated With Chronic Obstructive Pulmonary Disease (COPD) in Distrito Federal, Brazil, Before and After the Change in 2018 State COPD Protocol Version - Real-world Data

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tiotropium treatment - MAT1 Period<br>In the MAT1 (total arithmetic mean 1) period, August 2017 to July 2018, patients received Tiotropium bromide (SPIRIVA® RESPIMAT®) as part of the treatment plan for Chronic Obstructive Pulmonary Disease (COPD) defined by the Health State Secretariat of Federal District in Brazil. | |
| Glycopyrronium treatment - MAT2 Period<br>In the MAT2 (total arithmetic mean 2) period, August 2018 to July 2019, patients received Glycopyrronium bromide (Seebri® Breezhaler®) as part of the treatment plan for Chronic Obstructive Pulmonary Disease (COPD) defined by the Health State Secretariat of Federal District in Brazil. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of hospital admissions in Chronic Obstructive Pulmonary Disease (COPD) patients |  | Up to 1 year, from August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period) | 
| Number of deaths of hospitalized Chronic Obstructive Pulmonary Disease (COPD) patients |  | Up to 1 year, from August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period) | 
| Total costs associated with Chronic Obstructive Pulmonary Disease (COPD) hospitalizations |  | Up to 1 year, from August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period) | 
| Infirmary beds | Defined as the average monthly number of available hospital beds | Up to 1 year, from August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of hospitalizations with intensive care unit (ICU) admissions over total number of hospitalizations |  | Up to 1 year, from August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period) | 
| Total costs associated with Chronic Obstructive Pulmonary Disease (COPD) hospitalizations with intensive care unit (ICU) admissions |  | Up to 1 year, from August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period) |