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

NCT ID: NCT06053541

Last Updated: 2024-10-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3015000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-01

Study Completion Date

2021-07-01

Brief Summary

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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

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Boehringer Ingelheim Brasil

São Paulo, , Brazil

Site Status

Countries

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Brazil

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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0205-0548

Identifier Type: -

Identifier Source: org_study_id

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