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

Boehringer Ingelheim

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Tiotropium and Olodaterol (Tio+Olo); Drug: Long-acting beta2-agonist and Inhaled corticosteroids (LABA and ICS)

Study type: Observational

Funder types: Industry

Identifiers

NCT04184297

1237-0094

Details and patient eligibility

About

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

Enrollment: 27,190 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

27,190 participants in 2 patient groups

Subjects initiated with Tiotropium and Olodaterol (Tio+Olo)

Treatment:

Drug: Tiotropium and Olodaterol (Tio+Olo)

Subjets initiated with LABA/LAMA/ICS

Description:

Long-acting beta2/ Long-acting muscarinic antagonists/Inhaled corticosteriods

Treatment:

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