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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06053541
• Other study ID #: 0205-0548
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: July 1, 2021

Study information

• Verified date: September 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1430
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Brazil	Boehringer Ingelheim Brasil	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)

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