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
Sponsor: Boehringer Ingelheim

ABCD
 
001-MCS-90-118_RD-08 (3.0) / Saved on: 25 Nov 2019 
Observational and Non-Interventional Study (ONIS) using 
Existing Data Protocol  
TITLE PAGE 
BI Study Number: 
0205-0548  
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 
NCT number: 
NCT06053541 
Medicinal product: 
Tiotropium bromide (SPIRIVA® RESPIMAT®) 
Date 
28-May-2021 
 
Page 1 of 4 
 
 

DF COPD Study Protocol 
 
 
Objective: to investigate 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.  
 
Methods: To analyze DATASUS, Brazilian Ministry of Health Public Database, data from 
patients ≥ 40 years old hospitalization and mortality rates due to COPD International 
Classification of Diseases (ICD) listed in the COPD DF Protocol 12 months before the protocol 
change (MAT 1) and 12 months after (MAT 2).  
 
Table 1: ICD filters, per the DF COPD Protocol1:  
 
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 
J44.8  
Other specified chronic obstructive 
pulmonary disease 
J44.9  
Chronic obstructive pulmonary disease, 
unspecified 
 
On DATASUS, data on DF 40 years old or older population hospitalization and mortality rates 
filtered by the ICDs listed in Table 1 will be analyzed. The searches generate a LOG in order to 
ensure methodology. The data will be available on Microsoft Excel.  
 
 
 
 

Table 2: Information Available in the Hospital DataSUS Database (SIH). 
 
DATASUS_COLUMN 
DATA 
MEANING 
UF_ZI 
530000 
STATE CODE 
ANO_CMPT 
2013 
YEAR 
MES_CMPT 
1 
MONTH 
N_AIH 
5312100277187 
Authorization of Admission Number (13 Numbers) Unique 
CEP 
71693046 
ZIP CODE PATIENT 
MUNIC_RES 
530160 
CITY CODE PATIENT 
NASC 
19970917 
BIRTHDAY PATIENT 
SEXO 
3 
GENDER 
UTI_MES_IN 
0 
UTI USE INDICATION 
QT_DIARIAS 
0 
QTY OF DAYS IN HOSPITAL 
PROC_SOLIC 
301050074 
REQUIRED PROCEDURE COD 
PROC_REA 
301050074 
PROCEDURE EXECUTED NUMBER 
VAL_SH 
570,9 
PROCEDURE VALUE (R$) 
VAL_SP 
153 
PROCEDURE WORKER VALUE (R$) 
VAL_TOT 
723,9 
TOTAL COST VALUE (R$) 
VAL_UTI 
0 
TOTAL COST ICU (R$) 
DT_INTER 
20121201 
ADMISSION DATA 
DT_SAIDA 
20121231 
HOSPITAL DISCHARGE DATA 
DIAG_PRINC 
J448 
ICD CODE DIAGNOSTHIC OF ADMISSION 
IDADE 
15 
AGE 
DIAS_PERM 
30 
NUMBER OF DAYS IN HOSPITAL 
MORTE 
0 
DEATH INDICATION 
CNES 
2650355 
HOSPITAL NATIONAL CODE 
 
The following outcomes will be analyzed:  
 
1. Number of hospital admissions with and without ICU admissions 
2. Hospital admission mortality with and without ICU admissions 
3. Total costs associated with COPD hospitalizations 
4. Infirmary beds (General and ICU beds) 
 

The statistical analyses will be performed with Mann-Whitney test considering a p <0.05 for 
statistical significance, as the DATASUS generates unpaired data. The collected data will 
generate an observational, cross-sectional study in the cohort of adult hospitalized COPD 
patients. 
 
 
References 
1. Governo do Distrito Federal. Protocolo de Atenção à Saúde: TRATAMENTO 
MEDICAMENTOSO DA DOENÇA PULMONAR OBSTRUTIVA CRÔNICA ESTÁVEL. Available 
at: http://www.saude.df.gov.br/wp-conteudo/uploads/2020/09/Protocolo-DPOC-SES-
DF.pdf Accessed on 19 Feb 2021.