Early Intervention Efficacy in COPD

Study Overview
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Brief Summary
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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.

Official Title
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Early Intervention Effectiveness of Tiotropium / Olodaterol Compared to Tiotropium in COPD

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: Tiotropium/Olodaterol
* Drug: Tiotropium


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tiotropium/Olodaterol<br>Combination of Tiotropium and Olodaterol | Drug: Tiotropium/Olodaterol<br>* Soft Mist Inhaler product<br>* Other names: Spiolto®;|
| Tiotropium<br> | Drug: Tiotropium<br>* Soft Mist Inhaler product<br>* Other names: Spiriva®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Triple Therapy Initiation | Time to triple therapy initiation (first event per patient) defined as any fixed dose combination of Long-acting muscarinic antagonists (LAMA) / Long-acting beta agonist (LABA) / Inhaled Corticosteroid (ICS) or any concurrent use for 30 consecutive days of the following: any LAMA/LABA fixed dose combination + any ICS single formulation any LAMA single formulation + any LABA/ICS fixed dose combination any LAMA single formulation + any LABA single formulation + any ICS single formulation. Patients will be censored if they had an occurrence of any of the following: outcome (initiation of triple therapy), death, or end of data. The analysis will use an intention-to-treat censoring approach, which does not account for treatment change. | From index date (cohort entry date) until first occurence of event, up to 42 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | Time to First Moderate or Severe COPD Exacerbation. Moderate exacerbation is defined as an outpatient visit with a diagnosed code for COPD in any field + a prescription for an oral corticosteroid or an antibiotic for respiratory infections. Severe exacerbations will be defined as a hospitalization with a primary diagnosis for COPD. Patients will be censored if they had an occurrence of any of the following: outcome (initiation of triple therapy), death, or end of data. The analysis will use an intention-to-treat censoring approach, which does not account for treatment change. | From index date until first occurence of event, up to 42 months. | 
| Number of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | Number of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations. Moderate exacerbation is defined as an outpatient visit with a diagnosed code for COPD in any field + a prescription for an oral corticosteroid or an antibiotic for respiratory infections. Severe exacerbations will be defined as a hospitalization with a primary diagnosis for COPD. Patients will be censored if they had an occurrence of any of the following: outcome (initiation of triple therapy), death, or end of data. The analysis will use an intention-to-treat censoring approach, which does not account for treatment change. | From index date until first occurence of event, up to 42 months. |