Impact of Particulate Matter in Chronic Obstructive Pulmonary Disease Patients

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04020237
• Other study ID #: 2019-0476
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 11, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2019
• Source: Asan Medical Center
• Contact: Sei Won Lee
• Phone: 82-2-3010-3990
• Email: iseiwon[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sei Won Lee	Korea Centers for Disease Control & Prevention

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from pulmonary function test at 1 year	Forced Expiratory Volume at 1 second level	Up to 1 year