N/A N=3,015,000

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

Pulmonary Disease, Chronic Obstructive

Bottom Line

View on ClinicalTrials.gov: NCT06053541 ↗

Enrolled (actual)

3,015,000

Serious AEs

—

Results posted

Oct 2024

Primary outcome: Primary: Number of Hospital Admissions in Chronic Obstructive Pulmonary Disease (COPD) Patients — 665; 765 Hospitalizations — p=0.24

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Jul 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Hospital Admissions in Chronic Obstructive Pulmonary Disease (COPD) Patients	665; 765	0.24
PRIMARY Number of Deaths of Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients	52; 67	0.37
PRIMARY Total Costs Associated With Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations	828761.94; 1267318.42	0.03 sig
PRIMARY Infirmary Beds	883.8; 895.5; 150.7; 146.6	0.11
SECONDARY Number of Hospitalizations With Intensive Care Unit (ICU) Admissions Over Total Number of Hospitalizations	16; 37	0.01 sig
SECONDARY Total Costs Associated With Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations With Admission to Intensive Care Unit (ICU)	149145.17; 298051.06	0.07

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06053541). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.