Comparative Effectiveness and Safety of Tiotropium and Olodaterol in Comparison to Triple Therapy

Boehringer Ingelheim27,190 enrolled

Overview

To assess the comparative effectiveness of combination Tiotropium and Olodaterol (Tio+Olo) (FDC) compared to combination LAMA/LABA and ICS (fixed or open), and to explore whether this varies across COPD sub populations defined by exacerbation risk

Study Type

OBSERVATIONAL

Enrollment

27,190

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium and Olodaterol (Tio+Olo)DRUG

drug

Long-acting beta2-agonist and Inhaled corticosteroids (LABA and ICS)DRUG

drug

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * New users of Tio+Olo on the same date or of LABA, LAMA and ICS, either as a fixed-dose combination (LABA/LAMA/ICS) or free combination (LABA/ICS + LAMA, etc), on the same date between January 2013 and March 2019. * Diagnosis of COPD prior to first maintenance inhaler and age ≥ 40 years at index date Exclusion Criteria: * Less than one year of medical history information prior to the date of combined treatment initiation (index date) * Lung cancer, interstitial lung disease, or lung transplantation at any time prior to the index date * Asthma diagnosis within one year prior to the index date

Locations (1)

HealthCore, Inc.

Andover, Massachusetts, United States

Outcomes

Primary Outcomes

Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation was reported. Time to the first Chronic obstructive pulmonary disease (COPD) exacerbation will be measured from cohort entry until the occurrence of a hospitalization for COPD (severe exacerbation) or Emergency Department (ED) visit for COPD with the prescription of an antibiotic and/or an oral corticosteroid on the same day (moderate exacerbation).

Time frame: From cohort entry (index date) until the occurrence of a hospitalization for COPD (severe exacerbation), ED visit for COPD or prescription of an antibiotic and oral corticosteroid on the same day (moderate exacerbation). Up to 1 year after cohort entry.

Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation - Without Exacerbation Within 30 Days Prior to Cohort Entry

Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation excluding participants who had exacerbation within 30 days prior to cohort entry, was reported. Time to the first Chronic obstructive pulmonary disease (COPD) exacerbation will be measured from cohort entry until the occurrenceof a hospitalization for COPD (severe exacerbation) or Emergency Department (ED) visit for COPD with the prescription of an antibiotic and/or an oral corticosteroid on the same day (moderate exacerbation).

Secondary Outcomes

Overall Incidence Rate of Hospitalization for Community-acquired Pneumonia (Serious Pneumonia)

Overall incidence rate of first hospitalization for community-acquired pneumonia (serious pneumonia).

Time frame: From cohort entry (index date) until the occurrence of hospitalization for community-acquired pneumonia (serious pneumonia). Up to 1 year after cohort entry.

Data from ClinicalTrials.gov

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