N/A
Completed N=42,953
Comparative Effectiveness and Safety of Tiotropium and Olodaterol in Comparison to LABA/ICS
Source: ClinicalTrials.gov NCT04138758 ↗Enrolled (actual)
42,953
Serious AEs
—
Results posted
Nov 2020
Primary outcomePrimary: Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation — 1.63; 2.43 Events per 1,000 Person-days
Summary
The primary objective is to compare the effectiveness of maintenance therapy initiation with the combination treatment Tiotropium and Olodaterol (Olo+Tio) compared with LABA/ICS combination in COPD as the time to the first COPD exacerbation.
Secondary objectives are to compare patients treated with Tio+Olo and patients treated with LABA/ ICS combination.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation |
1.63; 2.43 | — |
| SECONDARY Incidence Rate of First Hospitalization for Community-acquired Pneumonia |
0.23; 0.34 | — |
| SECONDARY Incidence Rate of the First Date of a Pharmacy Dispensing Indicating Escalation (Original Case Definition) to Triple Therapy |
0.54; 2.90 | — |
| SECONDARY Incidence Rate of the First Date of a Pharmacy Dispensing Indicating Escalation (Alternative Case Definition) to Triple Therapy |
0.57; 3.14 | — |
| SECONDARY Incidence Rate of Any Element of a Composite Outcome Including Exacerbation, Hospitalization for Pneumonia, or Escalation (Original Case Definition) to Triple Therapy |
2.14; 5.45 | — |
| SECONDARY Incidence Rate of Any Element of a Composite Outcome Including Exacerbation, Hospitalization for Pneumonia, or Escalation (Alternative Case Definition) to Triple Therapy |
2.16; 5.67 | — |
Eligibility Criteria
Inclusion Criteria
- At least one prescription for Tio+Olo combined inhaler or a LABA/ICS combined inhaler between 1 January 2013 and 31 March 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. Sensitivity analyses will also accept free combinations of LABA/ICS.
- At least one diagnosis of COPD at any time prior to the index date.
- At least one year of continuous medical and pharmacy health plan eligibility prior to the index date will be required to allow a baseline period for the covariates and identification of new use of the study drugs.
Exclusion Criteria
- To increase the likelihood of a true diagnosis of COPD, we will exclude:
- All patients less than 40 years of age on the index date, and
- All patients with a diagnosis of asthma in the year prior to the index date
- To limit the population to those without severe lung compromise outside of COPD, we will exclude individuals with lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date
- To restrict the cohort to new users of Tio+Olo or LABA/ICS, we will exclude any individual with use of either Tio+Olo, LABA/ICS, or LABA/LAMA/ICS combination therapy in free or fixed form for at least one year prior to the index date.
Data sourced from ClinicalTrials.gov (NCT04138758). 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.