Early Intervention Efficacy in COPD

Boehringer Ingelheim

Status

Completed

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Drug: Tiotropium/Olodaterol

Drug: Tiotropium

Study type

Observational

Funder types

Industry

Identifiers

NCT04249310

1237-0100

Details and patient eligibility

About

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.

Enrollment

6,788 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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 <40 years on cohort entry.
Any LAMA, LABA, or ICS maintenance therapy (alone or in combination) during the 180-day baseline period prior to cohort entry for maintenance treatment and duration >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.