Impact of Particulate Matter in Chronic Obstructive Pulmonary Disease Patients

NCT04020237 | Unknown

• 1 other identifier: 2019-0476
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from pulmonary function test at 1 year

  Up to 1 year

Study Arms (2)

Observational arm

NO INTERVENTION

General counselling to particulate matter practice score.

Interventional arm

OTHER

Active education and feedback on the particulate matter practice score that affects real life.

Behavioral: Education about particulate matter practice score

Interventions

Education about particulate matter practice score BEHAVIORAL

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.

Interventional arm

Eligibility Criteria

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

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Sei Won Lee: lead
• Korea Centers for Disease Control & Prevention: collaborator

Related Publications (1)

• 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.

  PMID: 33168558 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

  Asan Medical Center

  STUDY DIRECTOR

Central Study Contacts

Sei Won Lee

CONTACT

82-2-3010-3990; iseiwon@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 16, 2019
• Study Start: July 11, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: July 17, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share