Clinical trial NCT06053541: Morbid Rates After Spiriva Chronic Obstructive Pulmonary Disease (COPD) Protocol Change
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2023-09-25
Enrollment: 3015000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Hospital Admissions in Chronic Obstructive Pulmonary Disease (COPD) Patients
timeFrame: From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.
measure: Number of Deaths of Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients
timeFrame: From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.
measure: Total Costs Associated With Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations
timeFrame: From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.
measure: Infirmary Beds
timeFrame: 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:
measure: Number of Hospitalizations With Intensive Care Unit (ICU) Admissions Over Total Number of Hospitalizations
timeFrame: From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.
measure: Total Costs Associated With Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations With Admission to Intensive Care Unit (ICU)
timeFrame: From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Boehringer Ingelheim Brasil
Study officials:
References: