N/A
Completed N=27,190
Comparative Effectiveness and Safety of Tiotropium and Olodaterol in Comparison to Triple Therapy
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT04184297 ↗
Enrolled (actual)
27,190
Serious AEs
—
Results posted
Nov 2020
Primary outcomePrimary: Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation — 1.32; 1.14 Events per 1000 person-days
Summary
To assess the comparative effectiveness of combination Tiotropium and Olodaterol (Tio+Olo) (FDC) compared to combination LAMA/LABA and ICS (fixed or open), and to explore whether this varies across COPD sub populations defined by exacerbation risk
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation |
1.32; 1.14 | — |
| PRIMARY Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation - Without Exacerbation Within 30 Days Prior to Cohort Entry |
1.18; 0.99 | — |
| SECONDARY Overall Incidence Rate of Hospitalization for Community-acquired Pneumonia (Serious Pneumonia) |
0.25; 0.24 | — |
Eligibility Criteria
Inclusion Criteria
- New users of Tio+Olo on the same date or of LABA, LAMA and ICS, either as a fixed-dose combination (LABA/LAMA/ICS) or free combination (LABA/ICS + LAMA, etc), on the same date between January 2013 and March 2019.
- Diagnosis of COPD prior to first maintenance inhaler and age ≥ 40 years at index date
Exclusion Criteria
- Less than one year of medical history information prior to the date of combined treatment initiation (index date)
- Lung cancer, interstitial lung disease, or lung transplantation at any time prior to the index date
- Asthma diagnosis within one year prior to the index date
Data sourced from ClinicalTrials.gov (NCT04184297). 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.