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

Boehringer Ingelheim

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Study type: Observational

Funder types: Industry

Identifiers

NCT06053541

0205-0548

Details and patient eligibility

About

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.

Enrollment: 3,015,000 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

3,015,000 participants in 1 patient group

Patients diagnosed with COPD, admitted to the hospital with acute exacerbations

Description:

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.