Impact of Particulate Matter in Chronic Obstructive Pulmonary Disease Patients

NCT ID: NCT04020237

Last Updated: 2019-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-11

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Observational arm

General counselling to particulate matter practice score.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventional arm

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

Group Type OTHER

Education about particulate matter practice score

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea Centers for Disease Control & Prevention

UNKNOWN

Sponsor Role collaborator

Sei Won Lee

OTHER

Sponsor Role lead

Responsible Party

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Sei Won Lee

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sei Won Lee

Role: STUDY_DIRECTOR

Asan Medical Center

Central Contacts

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Sei Won Lee

Role: CONTACT

82-2-3010-3990

References

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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.

Reference Type DERIVED
PMID: 33168558 (View on PubMed)

Other Identifiers

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2019-0476

Identifier Type: -

Identifier Source: org_study_id

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