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

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive

• Study Type: Observational
• Enrollment (Actual): 3015000

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 04794-000
    • Boehringer Ingelheim Brasil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients over 40 years of age, diagnosed with Chronic Obstructive Pulmonary Disease (COPD), admitted to the hospital with acute exacerbations of the disease between August 2017 and July 2019 in Federal District, Brazil.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Hospital Admissions in Chronic Obstructive Pulmonary Disease (COPD) Patients	Number of hospital admissions in Chronic Obstructive Pulmonary Disease (COPD) patients, is reported, the same patient could be hospitalized more than once a year.	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	Number of deaths of hospitalized Chronic Obstructive Pulmonary Disease (COPD) patients, the same patient could be hospitalized more than once a year.	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	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.	From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.
Infirmary Beds	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.	From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Hospitalizations With Intensive Care Unit (ICU) Admissions Over Total Number of Hospitalizations	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.	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)	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.	From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 0205-0548

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

https://www.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No