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Completed

NCT Number: NCT06053541

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

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.

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Brasil

São Paulo, 04794-000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of Hospital Admissions in Chronic Obstructive Pulmonary Disease (COPD) Patients

    Time frame: 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 hospital admissions in Chronic Obstructive Pulmonary Disease (COPD) patients, is reported, the same patient could be hospitalized more than once a year.

  2. Number of Deaths of Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients

    Time frame: 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, the same patient could be hospitalized more than once a year.

  3. Total Costs Associated With Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations

    Time frame: 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 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.

  4. Infirmary Beds

    Time frame: From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.

    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.

Secondary outcomes

  1. Number of Hospitalizations With Intensive Care Unit (ICU) Admissions Over Total Number of Hospitalizations

    Time frame: 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 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.

  2. Total Costs Associated With Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations With Admission to Intensive Care Unit (ICU)

    Time frame: 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) , is reported, the same patient could have been hospitalized more than once a year.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 25, 2023
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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