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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT06053541
Collaborator
(none)
1,430
Enrollment
1
Location
3
Actual Duration (Months)
478.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1430 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    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
    Actual Study Start Date :
    Apr 1, 2021
    Actual Primary Completion Date :
    Jul 1, 2021
    Actual Study Completion Date :
    Jul 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Tiotropium treatment - MAT1 Period

    In the MAT1 (total arithmetic mean 1) period, August 2017 to July 2018, patients received Tiotropium bromide (SPIRIVA® RESPIMAT®) as part of the treatment plan for Chronic Obstructive Pulmonary Disease (COPD) defined by the Health State Secretariat of Federal District in Brazil.
    Glycopyrronium treatment - MAT2 Period

    In the MAT2 (total arithmetic mean 2) period, August 2018 to July 2019, patients received Glycopyrronium bromide (Seebri® Breezhaler®) as part of the treatment plan for Chronic Obstructive Pulmonary Disease (COPD) defined by the Health State Secretariat of Federal District in Brazil.

    Outcome Measures

    Primary Outcome Measures

    1. 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)]

    2. 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)]

    3. 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)]

    4. Infirmary 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)]

      Defined as the average monthly number of available hospital beds

    Secondary Outcome Measures

    1. 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)]

    2. 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)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Boehringer Ingelheim Brasil São Paulo Brazil 04794-000

    Sponsors and Collaborators

    • Boehringer Ingelheim

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Boehringer Ingelheim
    ClinicalTrials.gov Identifier:
    NCT06053541
    Other Study ID Numbers:
    • 0205-0548
    First Posted:
    Sep 25, 2023
    Last Update Posted:
    Sep 25, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Diseases
    Lung Diseases, Obstructive
    Pulmonary Disease, Chronic Obstructive

    Study Results

    No Results Posted as of Sep 25, 2023