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

Completed

• Conditions: COPD

• Registration Number: NCT05903989
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-25
• Study First Submitted QC: 2023-06-12
• Study First Posted: 2023-06-15
• Study Start: 2023-09-11
• Primary Completion: 2023-10-24
• Study Completion: 2023-10-24
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 708

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)	At registration	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

Secondary Outcome Measures

Name	Time	Method
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	1 year follow-up	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
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	1 year follow-up	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
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	1 year follow-up	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
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	1 year follow-up	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

Trial Locations

Locations (1)

Research Site; 🇯🇵 Osaka, Japan