N/A
Completed N=19,467
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
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT05393245 ↗
Enrolled (actual)
19,467
Serious AEs
—
Results posted
Dec 2024
Primary outcomePrimary: Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events — 10.63; 0.55; 0.84; 19.71 Events per 100 person-years
Summary
The aim of this real world study is to assess the safety profile of tiotropium/olodaterol (Tio/Olo).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events |
10.63; 0.55; 0.84; 19.71; 15.66; 17.06 | — |
| PRIMARY Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events |
6.80; 4.02; 0.33; 1.13; 0.59; 1.11 | — |
| SECONDARY Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Sex |
5167; 12263; 653; 1384 | — |
| SECONDARY Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Age |
905; 2826; 3151; 8080; 1764; 2741 | — |
| SECONDARY Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Calendar Year of Cohort Entry |
0; 218; 150; 945; 241; 2477 | — |
| SECONDARY Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Season of Cohort Entry Date |
1535; 3748; 1484; 3369; 1469; 3273 | — |
| SECONDARY Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Specific Previous COPD Treatment |
75; 465; 112; 670; 76; 44 | — |
| SECONDARY Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Use of Other Respiratory Drugs |
4324; 9541; 2468; 5913; 1670; 2719 | — |
| SECONDARY Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Moderate COPD Exacerbation in 1 Year Prior to Index Date |
5209; 12556; 483; 968; 128; 123 | — |
| SECONDARY Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Severe COPD Exacerbation in 1 Year Prior to Index Date |
5222; 12738; 520; 809; 78; 100 | — |
| SECONDARY Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All COPD Exacerbation in 1 Year Prior to Index Date |
4738; 11791; 802; 1548; 280; 308 | — |
| SECONDARY Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Moderate COPD Exacerbation 30 Days Prior to Index Date |
5628; 13115; 192; 532; 0; 0 | — |
| SECONDARY Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Severe COPD Exacerbation 30 Days Prior to Index Date |
5564; 13111; 256; 536; 0; 0 | — |
| SECONDARY Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All COPD Exacerbation 30 Days Prior to Index Date |
5390; 12612; 412; 1002; 18; 33 | — |
| SECONDARY Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Hospitalizations Caused by Exacerbation of COPD in 1 Year Prior to Index Date |
5475; 13149; 296; 443; 49; 55 | — |
| SECONDARY Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All-cause Hospitalizations in 1 Year Prior to Index Date |
3405; 9273; 1311; 2902; 1104; 1472 | — |
| SECONDARY Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Comorbidities in 1 Year Prior to Index Date |
2979; 5741; 857; 1155; 1217; 2407 | — |
| SECONDARY Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Charlson Comorbidity Index (CCI) in 1 Year Prior to Index Date |
1.33; 0.97 | — |
| SECONDARY Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date |
4027; 8720; 2192; 2192; 1064; 2227 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05393245). 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.