N/A
Completed N=6,788
Early Intervention Efficacy in COPD
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT04249310 ↗
Enrolled (actual)
6,788
Serious AEs
—
Results posted
Aug 2021
Primary outcomePrimary: Time to Triple Therapy Initiation — 195.0; 89.5 Days
Summary
This study aims to evaluate the time to escalation to triple therapy among the Japanese Chronic obstructive pulmonary disease (COPD) patients newly initiating therapy with a combination of Olodaterol and Tiotropium (herein referred to as Tio/Olo) using real world data.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Triple Therapy Initiation |
195.0; 89.5 | — |
| SECONDARY Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation |
116.3; 118.8; 125.6; 139.0; 134.0; 134.5 | — |
| SECONDARY Number of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations |
0.08; 0.08; 0.04; 0.04; 0.05; 0.05 | — |
Eligibility Criteria
Inclusion Criteria
The study cohort will include all patients who initiate Tiotropium/ Olodaterol (Tio/Olo) or Tiotropium (Tio) during the patient selection period.
Exclusion Criteria
The following exclusion criteria will then be applied to generate the unmatched cohort:
- Aged 30 days, or any prescription within the 30 days prior to cohort entry.
- Patients without continuous enrolment (days since first inpatient/ outpatient encounter in the data) during the baseline period.
- No prior diagnosis of COPD [International Classification of Diseases (ICD)-10: J41*, J43*, J44* and doubt (UTAGAIFLG) = 0 (no)]
- Patients without a second prescription claim of their index medication within 60 days after the cohort entry date.
- Diagnosis of asthma [ICD-10: J45* and doubt (UTAGAIFLG) = 0 (no)] during the baseline period.
- Diagnosis of lung cancer [ICD-10: C34*, D02.2, Z80.1, Z85.1 and doubt (UTALAIFLG) = 0 (no)] or lung transplant (Health claim code: 150317670, 150322510, 150322610, 150336510, 150336610, 150336710, 150399270) prior to the cohort entry date using all available data.
- Patients who initiate both Tio/Olo and Tio simultaneously on the cohort entry date.
- Any use of triple therapy (LAMA + LABA + ICS) during the baseline period or between the cohort entry date and 1 day prior to the start of follow-up.
Data sourced from ClinicalTrials.gov (NCT04249310). 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.