Status:
COMPLETED
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
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Brief Summary
The aim of this real world study is to assess the safety profile of tiotropium/olodaterol (Tio/Olo).
Eligibility Criteria
Inclusion
- Patients treated with Tio+Olo:
- Inclusion criteria:
- 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.
- Aged ≥ 40 years on the index date.
- At least one diagnosis of COPD at any time prior to or on the index date.
- 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.
- At least one record in the health insurance system database.
- Exclusion criteria:
- Any use of Tio+Olo in free or fixed form within one year prior to the index date.
- 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:
- 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.
- Aged ≥ 40 years on the index date.
- At least one diagnosis of COPD at any time prior to or on the index date-
- 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.
- At least one record in the health insurance system database.
- Exclusion criteria:
- Any use of LAMA+LABA in free or fixed form for one year prior to the index date.
- Individuals with asthma, allergic rhinitis, lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date.
Exclusion
Key Trial Info
Start Date :
September 30 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 7 2022
Estimated Enrollment :
19467 Patients enrolled
Trial Details
Trial ID
NCT05393245
Start Date
September 30 2022
End Date
December 7 2022
Last Update
December 4 2024
Active Locations (1)
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1
Health Data Research Center, National Taiwan University
Taiwan, China, 10617