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

NCT06053541 | Completed Results

• 1 other identifier: 0205-0548
• Study Type: observational
• Target: 3,015,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• 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.

• 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.

Study Arms (1)

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.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients younger than 40 yeas of age at the time of hospital admission

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Boehringer Ingelheim Brasil

São Paulo, 04794-000, Brazil

Location

Related Links

• Related Info

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 25, 2023
• Study Start: April 1, 2021
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: October 26, 2024
• Results First Posted: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)