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出境医 / 临床实验 / Impact of Particulate Matter in Chronic Obstructive Pulmonary Disease Patients

Impact of Particulate Matter in Chronic Obstructive Pulmonary Disease Patients

Study Description
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.

Condition or disease Intervention/treatment Phase
COPD Behavioral: Education about particulate matter practice score Not Applicable

Detailed 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
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of Quality of Life in Patients With Chronic Pulmonary Obstructive Disease According to Particular Matter Exposure
Estimated Study Start Date : July 11, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Arm Intervention/treatment
No Intervention: Observational arm
General counselling to particulate matter practice score.
Interventional arm
Active education and feedback on the particulate matter practice score that affects real life.
 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.
Outcome Measures
Primary Outcome Measures :
  1. Chage from life quality scale at 1 year [ Time Frame: Up to 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))


Secondary Outcome Measures :
  1. Change from pulmonary function test at 1 year [ Time Frame: Up to 1 year ]
    Forced Expiratory Volume at 1 second level


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Contacts
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Contact: Sei Won Lee 82-2-3010-3990 iseiwon@gmail.com

Sponsors and Collaborators
Sei Won Lee
Korea Centers for Disease Control & Prevention
Investigators
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Study Director: Sei Won Lee Asan Medical Center
Tracking Information
First Submitted Date  ICMJE July 9, 2019
First Posted Date  ICMJE July 16, 2019
Last Update Posted Date July 17, 2019
Estimated Study Start Date  ICMJE July 11, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2019) 		Chage from life quality scale at 1 year [ Time Frame: Up to 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))
Original Primary Outcome Measures  ICMJE
 (submitted: July 11, 2019) 		Chage from life quality scale at 1 year [ Time Frame: Up to 1 year ]
Via average of chronic obstructive pulmonary disease assessment test score or St. George's Respiratory Questionnaire score
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2019) 		Change from pulmonary function test at 1 year [ Time Frame: Up to 1 year ]
Forced Expiratory Volume at 1 second level
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Particulate Matter in Chronic Obstructive Pulmonary Disease Patients
Official Title  ICMJE Evaluation of Quality of Life in Patients With Chronic Pulmonary Obstructive Disease According to Particular Matter Exposure
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.
Detailed 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE COPD
Intervention  ICMJE 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.
Study Arms  ICMJE
  • No Intervention: Observational arm
    General counselling to particulate matter practice score.
  • Interventional arm
    Active education and feedback on the particulate matter practice score that affects real life.
    Intervention: Behavioral: Education about particulate matter practice score
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 11, 2019) 		120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sei Won Lee 82-2-3010-3990 iseiwon@gmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04020237
Other Study ID Numbers  ICMJE 2019-0476
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sei Won Lee, Asan Medical Center
Study Sponsor  ICMJE Sei Won Lee
Collaborators  ICMJE Korea Centers for Disease Control & Prevention
Investigators  ICMJE
Study Director: Sei Won Lee Asan Medical Center
PRS Account Asan Medical Center
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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