Effectiveness of Tiotropium + Olodaterol Versus Inhaled Corticosteroids (ICS) + Long-acting β2-agonists (LABA) Among COPD Patients in Taiwan

Boehringer Ingelheim

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Olodaterol (Olo); Drug: Tiotropium (Tio); Drug: Long-acting β2-agonists (LABA); Drug: Inhaled corticosteroids (ICS)

Study type: Observational

Funder types: Industry

Identifiers

NCT05402020

1237-0110

Details and patient eligibility

About

The real world study aims to assess effectiveness and safety profile between tiotropium/olodaterol (Tio/Olo) and inhaled corticosteroids(ICS) / Long-acting β2-agonists (LABA) in patients with chronic obstructive pulmonary disease (COPD) in Taiwan. The data used in this study will come from the Taiwan National Health Insurance (NHI) claims data between 2014 and 2019.

Enrollment: 17,018 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. At least one prescriptions for Tiotropium/Olodaterol (Tio/Olo) combined inhaler or Long-acting ß2 agonist / Inhaled Corticosteroids (LABA/ICS) combined inhaler between 1st January 2014 and 31st December 2019.

   1. The first dispensing of either Tio/Olo or LABA/ICS combined inhaler will be defined as the index date;
   2. For the main analyses, only fixed dose combination (FDC) inhalers will be included.

2. Aged ≥ 40 years on the index date (in a sensitivity analysis we will only include patients aged ≥ 55 years on the index date);

3. At least one diagnosis of chronic obstructive pulmonary disease (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, ICS/LABA, or ICS/LABA/ Long-acting muscarinic antagonists (LAMA) 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 (in a sensitivity analysis we will include patients with asthma);

Trial design

17,018 participants in 2 patient groups

Tiotropium + Olodaterol cohort

Description:

Subjects who initiated Tiotropium + Olodaterol between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.

Treatment:

Drug: Tiotropium (Tio)

Drug: Olodaterol (Olo)

Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) cohort

Description:

Subjects who initiated Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.

Treatment:

Drug: Inhaled corticosteroids (ICS)

Drug: Long-acting β2-agonists (LABA)