Impact of Particulate Matter in Chronic Obstructive Pulmonary Disease Patients

Evaluation of Quality of Life in Patients With Chronic Pulmonary Obstructive Disease According to Particular Matter Exposure

A prospective study will be conducted in patients with COPD. The investigators will suggest about intervention for preventing in recurrence and aggravation of adult chronic respiratory disease due to exposure to particulate matter.

Study Overview

• Status: Unknown
• Conditions: COPD
• Intervention / Treatment: Behavioral: Education about particulate matter practice score

Detailed Description

Study trends and intervention plans related to particulate matter exposure and adult chronic respiratory disease in literature Measurement of particulate matter exposure by individual activities and collection of clinical information Linkage between individual particulate matter exposure and clinical information Investigation about effectiveness of intervention to avoid particulate matter

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

Contacts and Locations

• Study Contact: Name: Sei Won Lee; Phone Number: 82-2-3010-3990; Email: iseiwon@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• COPD over 40 years of age
• Patients with pulmonary function tests with Forced expiratory volume at 1 second / forced vital capacity <0.7 and Forced expiratory volume at 1 second1 <80%

Exclusion Criteria:

• Patients under the age of 18
• Elderly people over 80 years old
• People with respiratory symptoms with modified Medical Research Council dyspnea scale 0
• Persons who do not understand the brief description of the particulate matter exposure device
• A person who does not agree to the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Observational arm; General counselling to particulate matter practice score.
Other: Interventional arm; Active education and feedback on the particulate matter practice score that affects real life.	Behavioral: Education about particulate matter practice score; For the intervention group, specific guidance is given to the patient who might be exposure in environment with higher particulate matter concentration.; 1) Start air purifier; 2) Do not go out and make it to the minimum when absolutely necessary; 3) It is recommended to wear a mask when going out.; 4) The investigators recommend a lot of water, fresh fruit and vegetables.; 5) Prepare an inhaler and use it when symptoms get worse.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chage from life quality scale at 1 year	Via average of total chronic obstructive pulmonary disease assessment test (CAT) score (total range 0-40, higher score means bad outcome, CAT score consisted of summed score about cough (0-5), phlegm (0-5), chest tightness (0-5), breathlessness (0-5), activites (0-5), confidence (0-5), sleep (0-5), energy (0-5))	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from pulmonary function test at 1 year	Forced Expiratory Volume at 1 second level	Up to 1 year

Collaborators and Investigators

• Sponsor: Sei Won Lee
• Collaborators: Korea Centers for Disease Control & Prevention
• Investigators: Study Director: Sei Won Lee, Asan Medical Center

Publications and helpful links

General Publications

• Park S, Ra SW, Kang SY, Kim HC, Lee SW. Effect of particulate matter exposure on patients with COPD and risk reduction through behavioural interventions: the protocol of a prospective panel study. BMJ Open. 2020 Nov 9;10(11):e039394. doi: 10.1136/bmjopen-2020-039394.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 11, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: July 9, 2019
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (Actual): July 16, 2019

Study Record Updates

• Last Update Posted (Actual): July 17, 2019
• Last Update Submitted That Met QC Criteria: July 15, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2019-0476

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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