COPDNCT04878367
Behavioral Interventions to Reduce Particulate Matter Exposure in Patients With COPD
A study testing Five active practices of living rules for responding to fine dust. in people with COPD, run by Asan Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- Five active practices of living rules for responding to fine dust.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2021to 31 Mar 2023
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 years of age or older
- Waste function test results show FEV1/FVC<0.7, FEV1 <80% of forecast
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- COPD
- Being tested
- Five active practices of living rules for responding to fine dust.
- 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.
Five active practices of living rules for responding to fine dust.Behavioural
- 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
| Study group | Role | What they receive |
|---|---|---|
| COPD_E | Experimental | COPD patients with intervention Receives: Behavioral: Five active practices of living rules for responding to fine dust. |
| COPD_C | No intervention | COPD patients without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
SGRQ-C
Quality of life
Measured: 12 months
CAT
Quality of life
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start1 Jun 2021
- Primary completion31 Dec 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- COPD without intervention group , with intervention group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sei Won Lee, Asan Medical Center
- Investigators
- Sei won Lee, Principal investigator, Seoul Asan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878367
- Sponsor's protocol ID
- 2021-0956
- Status last verified
- Apr 2023
- First submitted
- 28 Apr 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The resident registration number may be used when requesting data from the National Statistical Office or the Health Review and Assessment Service for future research analysis and data collection.
Publications
Ji HW, Kang J, Kim HC, Jung J, Lee SJ, Jung JY, Lee SW. The association between cumulative exposure to PM2.5 and DNA methylation measured using methyl-capture sequencing among COPD patients. Respir Res. 2024 Sep 9;25(1):335. doi: 10.1186/s12931-024-02955-3.
PubMed 39251997Kang J, Kim HC, Jang Y, Lee JB, Lee JS, Oh YM, Ji HW, Jung JY, Lee SW. Randomised controlled trial of a behavioural intervention to reduce exposure to PM2.5 in patients with COPD. Environ Int. 2023 Nov;181:108286. doi: 10.1016/j.envint.2023.108286. Epub 2023 Oct 24.
PubMed 37918066Kang 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.
PubMed 34889270
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Interventions to Reduce Particulate Matter Exposure in Patients With COPD
- ClinicalTrials.gov ID
- NCT04878367
- Acronym / sponsor ID
- 2021-0956
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 7 May 2021 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- COPD without intervention group , with intervention group
| Arm | Type | Receives |
|---|---|---|
| COPD_E | Experimental | Behavioral: Five active practices of living rules for responding to fine dust.COPD patients with intervention |
| COPD_C | No intervention | –COPD patients without intervention |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 40 years of age or older
- Waste function test results show FEV1/FVC<0.7, FEV1 <80% of forecast
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Five active practices of living rules for responding to fine dust.1. Check the fine dust weather forecast 2. Check the operation time and filter of the air purifier 3. Window ventilation 4. Inhalant is used or not 5. Bad fine dust: Refrain from going out | Behavioural | COPD_E |
Primary outcome
SGRQ-C
Time frame: 12 months
Quality of life
CAT
Time frame: 12 months
Quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Derived from this study: PubMed 39251997Ji HW, Kang J, Kim HC, Jung J, Lee SJ, Jung JY, Lee SW. The association between cumulative exposure to PM2.5 and DNA methylation measured using methyl-capture sequencing among COPD patients. Respir Res. 2024 Sep 9;25(1):335. doi: 10.1186/s12931-024-02955-3.
- Derived from this study: PubMed 37918066Kang J, Kim HC, Jang Y, Lee JB, Lee JS, Oh YM, Ji HW, Jung JY, Lee SW. Randomised controlled trial of a behavioural intervention to reduce exposure to PM2.5 in patients with COPD. Environ Int. 2023 Nov;181:108286. doi: 10.1016/j.envint.2023.108286. Epub 2023 Oct 24.
- Derived from this study: PubMed 34889270Kang 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.
- Individual participant dataSharing planned: Yes. The resident registration number may be used when requesting data from the National Statistical Office or the Health Review and Assessment Service for future research analysis and data collection.
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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 principal investigator
Seoul Asan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Five active practices of living rules for responding to fine dust. in people with COPD, run by Asan Medical Center at 1 site in South Korea.
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: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SGRQ-C (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT04878367, which also lists 3 linked publications.
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 18 Apr 2023.