Clinical trial NCT04249310: Early Intervention Efficacy in COPD
Official title: Early Intervention Effectiveness of Tiotropium / Olodaterol Compared to Tiotropium in COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2020-01-30
Enrollment: 6788
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study cohort will include all patients who initiate Tiotropium/Olodaterol (Tio/Olo) or Tiotropium (Tio) during the patient selection period. Initiation (new use) will be determined based on no prescription claims for Tio/Olo or Tio during the baseline period or during all available data prior to cohort entry date. All patients will additionally be required to have a second claim for the index medication within 60 days after cohort entry to ensure primary adherence of index therapy.

Brief 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.


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 \<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.

Primary outcomes:
measure: Time to Triple Therapy Initiation
timeFrame: From index date (cohort entry date) until first occurence of event, up to 42 months.
Secondary outcomes:
measure: Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
timeFrame: From index date until first occurence of event, up to 42 months.
measure: Number of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
timeFrame: From index date until first occurence of event, up to 42 months.
Other outcomes:
Locations:
city: Nara
country: Japan
facility: Nara Medical University
Study officials:
References: