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

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Registration Number: NCT06053541

Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 3015000

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.