Safety of Tiotropium + Olodaterol in Chronic Obstructive Pulmonary Disease (COPD) Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data

Boehringer Ingelheim

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Long-acting β2-agonists (LABAs); Drug: Tiotropium+Olodaterol; Drug: Long-acting muscarinic antagonists (LAMAs); Device: Spiolto Respimat

Study type: Observational

Funder types: Industry

Identifiers

NCT05393245

1237-0109

Details and patient eligibility

About

The aim of this real world study is to assess the safety profile of tiotropium/olodaterol (Tio/Olo).

Enrollment: 19,467 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patients treated with Tio+Olo:

Inclusion criteria:

1. At least one prescription for Tio+Olo (fixed dose combination (FDC) or free combination) as a new initiation between 1st January 2014 and 31st December 2019.
2. Aged ≥ 40 years on the index date.
3. At least one diagnosis of COPD at any time prior to or on the index date.
4. At least one year of continuous medical and health insurance plan prior to the index date will be required to allow for a look-back period for the covariates and identification of new use of the study drugs.
5. At least one record in the health insurance system database.

Exclusion criteria:

1. Any use of Tio+Olo in free or fixed form within one year prior to the index date.
2. Individuals with asthma, allergic rhinitis, lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date.

Patients using other Long-acting β2-agonists/Long-acting muscarinic antagonists (LAMA/LABAs):

Inclusion criteria:

1. At least one prescription for LAMA+LABA (FDC or free combination) other than Tio/Olo as a new initiation between 1st January 2014 and 31st December 2019.
2. Aged ≥ 40 years on the index date.
3. At least one diagnosis of COPD at any time prior to or on the index date-
4. At least one year of continuous medical and health insurance plan prior to the index date will be required to allow for a look-back period for the covariates and identification of new use of the study drugs.
5. At least one record in the health insurance system database.

Exclusion criteria:

1. Any use of LAMA+LABA in free or fixed form for one year prior to the index date.
2. Individuals with asthma, allergic rhinitis, lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date.

Trial design

19,467 participants in 2 patient groups

COPD patients treated with tiotropium and olodaterol (Tio+Olo)

Treatment:

Device: Spiolto Respimat

Drug: Tiotropium+Olodaterol

COPD patients using other Long-acting muscarinic antagonists/Long-acting β2-agonists (LAMA/LABAs)

Treatment:

Drug: Long-acting muscarinic antagonists (LAMAs)

Drug: Long-acting β2-agonists (LABAs)