Clinical trial NCT04878367: Behavioral Interventions to Reduce Particulate Matter Exposure in Patients With COPD
Official title: Behavioral Interventions to Reduce Particulate Matter Exposure in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: COPD without intervention group , with intervention group
Primary purpose: BASIC_SCIENCE

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: SGRQ-C
timeFrame: 12 months
measure: CAT
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Seoul Asan Hospital
name: Sei won Lee
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.