Behavioral Interventions to Reduce Particulate Matter Exposure in Patients With COPD

It is a prospective, multi-institutional clinical study and targets patients diagnosed with chronic obstructive pulmonary disease. About 120 subjects (35 at Ilsan Paik Hospital, 35 at Severance Hospital, and 50 at Asan Medical Center in Seoul) will be subject to a random allocation of 1:1. The arbitration group implements living rules for responding to fine dust, supports air purifiers, and only general guidance is implemented in the non-property group. Patients are recruited from Asan Medical Center in Seoul (Songpa-gu, Seoul), Severance Hospital ( Seodaemun-gu, Seoul), and Ilsan Paik Medical Center (Goyang, Gyeonggi-do) for 12 months. During outpatient visits, lung function tests and airway resistance tests shall be conducted, and surveys presented in the research plan shall be conducted.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Behavioral: Five active practices of living rules for responding to fine dust.

Detailed Description

It is a prospective and multi-institutional clinical study targeting patients with chronic obstructive pulmonary disease in general.

A total of 120 COPD patients will be recruited from three institutions: Asan Medical Center, Severance Hospital, and Ilsan Paik Hospital. (60/30/30 expected) A panel of COPD patients is established to conduct prospective studies, and measures to mediate recurrence and deterioration of adult chronic respiratory diseases due to exposure to fine dust are presented. Improvement of the lifestyle of the arbitration forces. Detailed research methods such as air purifier support are presented in the research plan.

In addition, a fine dust measurement researcher visits each household to measure indoor fine dust concentration. The measurement method of fine dust concentration will be using the process test method, IoT-based sensors, and direct-to-read measuring devices to measure Air Korea's air pollution. Detailed visit timing and methods are carried out in the manner specified in the research plan.

We collect sputum at every visit and blood at the last visit.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 40 years of age or older
• Waste function test results show FEV1/FVC<0.7, FEV1 <80% of forecast

Exclusion Criteria:

• Patients under 18 years of age with changes in medication (such as inhalants).
• Older people over 80 years of age.
• People with no respiratory symptoms with mMRC 0.
• Who doesn't understand a simple explanation for fine dust exposure devices.
• Someone who disagrees with the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COPD_E; COPD patients with intervention	Behavioral: Five active practices of living rules for responding to fine dust.; Check the fine dust weather forecast; Check the operation time and filter of the air purifier; Window ventilation; Inhalant is used or not; Bad fine dust: Refrain from going out
No Intervention: COPD_C; COPD patients without intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SGRQ-C	Quality of life	12 months
CAT	Quality of life	12 months

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Investigators: Principal Investigator: Sei won Lee, Seoul Asan Hospital

Publications and helpful links

General Publications

• Kang J, Jung JY, Huh JY, Ji HW, Kim HC, Lee SW. Behavioral interventions to reduce particulate matter exposure in patients with COPD. Medicine (Baltimore). 2021 Dec 10;100(49):e28119. doi: 10.1097/MD.0000000000028119.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: May 6, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2021-0956

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The resident registration number may be used when requesting data from the National Statistical Office or the Health Review and Assessment Service for future research analysis and data collection.
• IPD Sharing Time Frame: Data are available at the time of the analysis of the results after the clinical study.
• IPD Sharing Access Criteria: Gender, age, smoking power and address are collected anonymously.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No