Real-World Treatment Patterns and Patient Reported Outcome in COPD (REMIND)

Study Overview
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Brief Summary
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This retrospective observational study aims to report distribution of the proportion of symptomatic Chronic obstructive pulmonary disease (COPD) patients classified by the COPD Assessment Test (CAT) managed with single or dual inhaler treatment using the data at cohort entry in the COPD cohort study, and treatment change and longitudinal CAT score by each inhaler treatment will also be evaluated using the data during the follow-up period.

Official Title
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A Secondary Database Study Using COPD Cohort Study in Japan to Investigate Health Status of COPD Patients With Different Inhaler Treatment

Conditions
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COPD

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients taken with any of following inhaler treatments; LAMA, LAMA+LABA(both single and dual inhaler) or ICS+LABA(both single and dual inhaler) at cohort entry Exclusion Criteria: Patients enrolled at the sites participated in the COPD cohort study where not agreed on secondary use of data for this study
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 |
| --- | --- |
| LAMA<br> | |
| LAMA plus LABA<br> | |
| ICS plus LABA<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with CAT (≥10, <10) at registration in each inhaler treatment group (Long acting muscarinic antagonist(LAMA), LAMA+Long acting β2 agonist(LABA) or Inhaled corticosteroid(ICS) +LABA) | To describe the proportion of symptomatic(CAT ≥10) and non-symptomatic(CAT<10) COPD patients in each of 3 different inhaler treatment categories(LAMA, LAMA+LABA or ICS+LABA) at registration | At registration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with changes of inhaler treatment categories (step up or all other categories) during 1 year follow-up period by patients with CAT (≥10, <10) in each inhaler treatment group (LAMA, LAMA+LABA or ICS+LABA) at registration | To describe changes of inhaler treatment categories during the 1 year follow-up period in symptomatic/non-symptomatic COPD patients by 3 different inhaler treatment categories (LAMA, LAMA+LABA or ICS+LABA) at registration | 1 year follow-up | 
| Proportion of patients with all patterns of inhaler treatment category changes during 1 year follow-up period by patients with CAT (≥10, <10) in each inhaler treatment group (LAMA, LAMA+LABA or ICS+LABA) at registration | To describe changes of inhaler treatment categories during the 1 year follow-up period in symptomatic/non-symptomatic COPD patients by 3 different inhaler treatment categories (LAMA, LAMA+LABA or ICS+LABA) at registration | 1 year follow-up | 
| Proportion of patients with CAT (≥10, <10) after 1 year follow-up by patients with CAT (≥10, <10) in each inhaler treatment group (LAMA, LAMA+LABA or ICS+LABA) at registration | To describe the COPD symptom status assessed with CAT after 1 year follow-up period in symptomatic(CAT ≥10)/non-symptomatic(CAT<10) COPD patients by 3 different inhaler treatment categories (LAMA, LAMA+LABA or ICS+LABA) at registration | 1 year follow-up | 
| Mean change in the CAT scores between at registration and 1 year follow-up in each inhaler treatment group (LAMA, LAMA+LABA or ICS+LABA) at registration | To describe the change of COPD symptom status assessed with CAT during 1 year follow-up period by 3 different inhaler treatment categories (LAMA, LAMA+LABA or ICS+LABA) at registration | 1 year follow-up |