Behavioral Interventions to Reduce Particulate Matter Exposure in Patients With COPD

COPD Clinical Trial

Official title:

Behavioral Interventions to Reduce Particulate Matter Exposure in Patients With COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04878367
• Other study ID #: 2021-0956
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: April 2023
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• COPD

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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SGRQ-C	Quality of life	12 months
Primary	CAT	Quality of life	12 months