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

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

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.

Study Overview

• Status: Completed
• Conditions: COPD

• Study Type: Observational
• Enrollment (Actual): 708

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Out of 708 COPD patients registered in the COPD cohort study conducted in Japan, total of 448 patients received the following inhaler treatment at cohort entry will be included in this study; LAMA, LAMA+LABA or ICS+LABA .

The patients not treated with the above-listed inhalers or with no COPD treatment at cohort entry will not be included for this study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
LAMA
LAMA plus LABA
ICS plus LABA

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2023
• Primary Completion (Actual): October 24, 2023
• Study Completion (Actual): October 24, 2023

Study Registration Dates

• First Submitted: May 25, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Estimated): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: D5980R00080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials/studies via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared
• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure