COPDNCT04020237
Impact of Particulate Matter in Chronic Obstructive Pulmonary Disease Patients
A study testing Education about particulate matter practice score in people with COPD, run by Sei Won Lee.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- Education about particulate matter practice score
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 11 Jul 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Quality of Life in Patients With Chronic Pulmonary Obstructive Disease According to Particular Matter Exposure
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.
Read the 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
- Conditions
- COPD
- Being tested
- Education about particulate matter practice score
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education about particulate matter practice scoreBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Education about particulate matter practice score |
What is being measured
The primary outcome is the main question the study is designed to answer.
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))
Measured: Up to 1 year
Secondary outcomes (1)
Change from pulmonary function test at 1 year
Forced Expiratory Volume at 1 second level
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start11 Jul 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sei Won Lee
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Centers for Disease Control & Prevention
- Responsible party
- Sponsor-investigator, Sei Won Lee, Asan Medical Center
- Investigators
- Sei Won Lee, Study director, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020237
- Sponsor's protocol ID
- 2019-0476
- Status last verified
- Jul 2019
- First submitted
- 9 Jul 2019
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33168558
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Quality of Life in Patients With Chronic Pulmonary Obstructive Disease According to Particular Matter Exposure
- ClinicalTrials.gov ID
- NCT04020237
- Acronym / sponsor ID
- 2019-0476
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sei Won LeeUniversity, hospital or other
- Collaborators
- Korea Centers for Disease Control & Prevention
- Study start
- 11 Jul 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 16 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observational arm | No intervention | –General counselling to particulate matter practice score. |
| Interventional arm | Other | Behavioral: Education about particulate matter practice scoreActive education and feedback on the particulate matter practice score that affects real life. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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%
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education about particulate matter practice scoreFor 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. | Behavioural | Interventional arm |
Primary outcome
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))
1 secondary outcome
Change from pulmonary function test at 1 year
Time frame: Up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Derived from this study: PubMed 33168558Park 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sei Won Lee study director
Asan Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Education about particulate matter practice score in people with COPD, run by Sei Won Lee.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sei Won Lee (82-2-3010-3990, iseiwon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chage from life quality scale at 1 year (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04020237, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2019.