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NCT05903989 Clinical Trial

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

COPD Clinical Trial

— REMIND  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05903989
Other study ID # D5980R00080
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 11, 2023
Est. completion date October 24, 2023

Study information
Verified date May 2024
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 708
Est. completion date October 24, 2023
Est. primary completion date October 24, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Research Site Osaka

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of patients with CAT (=10, <10) at registration in each inhaler treatment group (Long acting muscarinic antagonist(LAMA), LAMA+Long acting ß2 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 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
Secondary 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
Secondary 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
Secondary 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
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