Effectiveness of Tiotropium + Olodaterol Versus Inhaled Corticosteroids (ICS) + Long-acting β2-agonists (LABA) Among COPD Patients in Taiwan
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Tio/Olo cohort COPD patients included in the NHI database between 2014 and 2019 and who received Tiotropium/olodaterol (Tio/Olo). |
Drug: Tiotropium (Tio)
Tiotropium (Tio)
Drug: Olodaterol (Olo)
Olodaterol (Olo)
Device: Combined Inhaler
Combined Inhaler
|
| ICS/LABA cohort COPD patients included in the NHI database between 2014 and 2019 and who received inhaled corticosteroids/ Long-acting ß2-agonists (ICS/LABA). |
Drug: Inhaled corticosteroids (ICS)
Inhaled corticosteroids (ICS)
Drug: Long-acting β2-agonists (LABA)
Long-acting β2-agonists (LABA)
Device: Combined Inhaler
Combined Inhaler
|
Outcome Measures
Primary Outcome Measures
- Time to the first moderate or severe COPD exacerbations after index date [Up to 5 years.]
Secondary Outcome Measures
- Time to triple therapy escalation after index date [Up to 5 years.]
- Incidence rate of triple therapy initiation (first event per patient) [Up to 5 years.]
- Time to the first hospitalization for community-acquired pneumonia after entry [Up to 5 years.]
- Annualized rate of prescriptions of rescue medications after the index date [Up to 5 years.]
Annualized rate=number of prescriptions/total patient year at risk. Total patient year at risk=number of prescriptions per patient year.
- Annualized rate of moderate or severe COPD exacerbation after the index date [Up to 5 years.]
Annualized rate=number of moderate or severe COPD exacerbations/total patient year at risk. Total patient year at risk = number of exacerbations per patient year.
Eligibility Criteria
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.
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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);
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Tawain University Hospital | Taipei | China | 100225 |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 1237-0110