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

NCT05903989 | Completed

• 1 other identifier: D5980R00080
• Study Type: observational
• Target: 708
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (3)

LAMA

LAMA plus LABA

ICS plus LABA

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients enrolled at the sites participated in the COPD cohort study where not agreed on secondary use of data for this study

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Osaka, Japan

Location

Related Publications (1)

• Gon Y, Sorimachi R, Yoshida Y, Tamai Y, Takashima I, Arita Y, Sugiura H. Real-World Treatment Patterns and Patient-Reported Outcomes in Chronic Obstructive Pulmonary Disease in Japan: The REMIND Study. Adv Ther. 2024 Sep;41(9):3585-3597. doi: 10.1007/s12325-024-02927-5. Epub 2024 Jul 24.

  PMID: 39046695 DERIVED

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 15, 2023
• Study Start: September 11, 2023
• Primary Completion: October 24, 2023
• Study Completion: October 24, 2023
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• 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.
• 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

Locations

JP (1)