Real-World Treatment Patterns and Patient reported outcome in COPD (REMIND) A secondary database study using COPD cohort study in Japan to investigate health status of COPD patients with different inhaler treatment

JRCT ID: jRCT1030230176

Registered date:25/06/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: COPD
• Date of first enrollment: 25/06/2023
• Target sample size: 448
• Study type: Observational

Outcome(s)

• Primary Outcome: 1)Proportion of patients with CAT (>=10, <10) in each inhaler treatment group at cohort entry

Secondary Outcome

1-1)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 at cohort entry
1-2) 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 at cohort entry
2) Proportion of patients with CAT (>=10, <10) at 1 year follow-up by patients with CAT (>=10, <10) in each inhaler treatment group at cohort entry
3) Mean change in the CAT scores between cohort entry and 1 year follow-up in each inhaler treatment group (LAMA, LAMA+LABA or ICS+LABA) at cohort entry

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: 1)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)
• Exclude criteria: 1)Patients enrolled at the sites participated in the COPD cohort study where not agreed on secondary use of data for this study

Related Information

• Primary Sponsor: Tanaka Michio
• Source(s) of Monetary Support: AstraZeneca K.K.
• Secondary ID(s): NCT05903989