N/A
Completed N=17,018
Effectiveness of Tiotropium + Olodaterol Versus Inhaled Corticosteroids (ICS) + Long-acting β2-agonists (LABA) Among COPD Patients in Taiwan
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT05402020 ↗
Enrolled (actual)
17,018
Serious AEs
—
Results posted
Aug 2024
Primary outcomePrimary: Number of Subjects With Event First Moderate or Severe COPD Exacerbations After Index Date — 424; 375 Participants
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Event First Moderate or Severe COPD Exacerbations After Index Date |
424; 375 | — |
| SECONDARY Number of Subjects With Event Triple Therapy Escalation After Index Date |
122; 153 | — |
| SECONDARY Incidence Rate of Triple Therapy Initiation |
76.2; 114.2 | — |
| SECONDARY Number of Subjects With Event First Hospitalization for Community-acquired Pneumonia After Entry |
11; 11 | — |
| SECONDARY Annualized Rate of Prescriptions of Rescue Medications After the Index Date |
0.86; 1.03 | — |
| SECONDARY Annualized Rate of COPD Exacerbations After Index Date |
0.36; 0.37 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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);
Data sourced from ClinicalTrials.gov (NCT05402020). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.