Behavioral Interventions to Reduce Particulate Matter Exposure in Patients With COPD

NCT04878367 | Completed DMC

• 1 other identifier: 2021-0956
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (2)

• SGRQ-C

  Quality of life

  12 months

• CAT

  Quality of life

  12 months

Study Arms (2)

COPD_E

EXPERIMENTAL

COPD patients with intervention

Behavioral: Five active practices of living rules for responding to fine dust.

COPD_C

NO INTERVENTION

COPD patients without intervention

Interventions

Five active practices of living rules for responding to fine dust. BEHAVIORAL

1. Check the fine dust weather forecast 2. Check the operation time and filter of the air purifier 3. Window ventilation 4. Inhalant is used or not 5. Bad fine dust: Refrain from going out

COPD_E

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

Related Publications (3)

• Ji HW, Kang J, Kim HC, Jung J, Lee SJ, Jung JY, Lee SW. The association between cumulative exposure to PM2.5 and DNA methylation measured using methyl-capture sequencing among COPD patients. Respir Res. 2024 Sep 9;25(1):335. doi: 10.1186/s12931-024-02955-3.

  PMID: 39251997 DERIVED

• Kang J, Kim HC, Jang Y, Lee JB, Lee JS, Oh YM, Ji HW, Jung JY, Lee SW. Randomised controlled trial of a behavioural intervention to reduce exposure to PM2.5 in patients with COPD. Environ Int. 2023 Nov;181:108286. doi: 10.1016/j.envint.2023.108286. Epub 2023 Oct 24.

  PMID: 37918066 DERIVED

• 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.

  PMID: 34889270 DERIVED

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 Officials

• Sei won Lee

  Seoul Asan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: COPD without intervention group , with intervention group

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 7, 2021
• Study Start: June 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data are available at the time of the analysis of the results after the clinical study.
• Access Criteria: Gender, age, smoking power and address are collected anonymously.

Locations

KR (1)