Status:
COMPLETED
Effectiveness of Tiotropium + Olodaterol Versus Inhaled Corticosteroids (ICS) + Long-acting β2-agonists (LABA) Among COPD Patients in Taiwan
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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.
- The first dispensing of either Tio/Olo or LABA/ICS combined inhaler will be defined as the index date;
- For the main analyses, only fixed dose combination (FDC) inhalers will be included.
- Aged ≥ 40 years on the index date (in a sensitivity analysis we will only include patients aged ≥ 55 years on the index date);
- At least one diagnosis of chronic obstructive pulmonary disease (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
- 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;
- 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);
Key Trial Info
Start Date :
September 30 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 13 2023
Estimated Enrollment :
17018 Patients enrolled
Trial Details
Trial ID
NCT05402020
Start Date
September 30 2022
End Date
February 13 2023
Last Update
August 9 2024
Active Locations (1)
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1
National Tawain University Hospital
Taipei, China, 100225