Chronic Obstructive Pulmonary DiseaseNCT03813810
Impact of Air Pollution on Chronic Respiratory Diseases
An observational study of Chronic Obstructive Pulmonary Disease and Asthma, run by Seoul National University Hospital.
Trial summary
The aim of this study is to evaluate the impact of air pollution on the occurrence and clinical course of chronic respiratory diseases, and discover new biomarkers from various devices such as CT images that can indicate the process and amount of lung damage caused by air pollution. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Asthma, Idiopathic Pulmonary Fibrosis
- What is being tested?
- Non
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- 25 Jan 2019to Dec 2021
- Phase
- Observational
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal adults and adult patients with chronic respiratory disease (chronic obstructive pulmonary disease, asthma, idiopathic pulmonary fibrosis)
Who may be able to join
- Normal: People with no lung lesions in chest X-ray and St. George's Respiratory Questionnaire score <25, and post bronchodilator FEV1/FVC (forced expiratory volume at one second/forced vital capacity) >= 0.7 and FEV1 >= 80% and FVC >= 80%.
- Chronic obstructive pulmonary disease: Patients with over 10 pack-years of smoking history and post bronchodilator FEV1/FVC <0.7 and FEV1 < 80%, and no other reason for decline of lung function.
- Asthma: Patients with FEV1/FVC < 0.85 and increase in over 12% and 200mL of FEV1 by bronchodilator inhalation. Patients with P20 < 16mg/dL by bronchial provocation test.
- Idiopathic pulmonary fibrosis: Shows usual interstitial pneumonia according to chest CT and has no other reasons such as systematic diseases or medication history.
Who cannot join
- Subjects who refused for enrollment in the study
- Subjects who experienced an acute exacerbation within 1 month.
- Subjects under age of 19.
About this study
Official title: The Impact of Air Pollution on Chronic Respiratory Diseases: a Prospective Cohort Study
The aim of this study is to evaluate the impact of air pollution on the occurrence and clinical course of chronic respiratory diseases, and discover new biomarkers from various devices such as CT images that can indicate the process and amount of lung damage caused by air pollution.
Accordingly, the investigators have designed an prospective cohort with enrollment of normal people and patients with chronic respiratory diseases of three different categories (chronic obstructive pulmonary disease, asthma, idiopathic pulmonary fibrosis). Participants will be followed up for a period of one year, with evaluation of the clinical course of the respiratory disease and exposure to air pollution.
Read the detailed description
Normal people (n=90) and patients with chronic respiratory diseases (chronic obstructive pulmonary disease, asthma, idiopathic pulmonary fibrosis, n=90 for each disease) will be enrolled at 5 different institutions in South Korea and followed up for one year. Inspiratory-expiratory CTs and tests including physical examination and blood/urine tests would be performed at the time of enrollment and the time at completion of the follow up period for each participant. Participants would be checked for the residency and working places, as well as checked for the amount of air pollution exposure using a wearable measurement device for 5 days during the study period ( time at enrollment / 3 months / 6 months / 9 months / time at completion). The device would cause no effect on usual daily life or the medical status of the participant. The clinical course such as occurrence of disease, acute exacerbation, decline of lung function, imaging status, mortality would be evaluated as well as the exposure of air pollution for each individual.
- Being tested
- Non
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NonOther
There would be no interventions. Only measurements will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Normal | People without any chronic pulmonary diseases. Receives: Other: Non | |
| Chronic obstructive pulmonary disease | Patients with chronic obstructive pulmonary disease. Receives: Other: Non | |
| Asthma | Patients with asthma Receives: Other: Non | |
| Idiopathic pulmonary fibrosis | Patients with idiopathic pulmonary fibrosis Receives: Other: Non |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of mortality
Events of mortality through study completion
Measured: an average of 1 year
Rate of acute exacerbations
Events of acute exacerbations through study completion
Measured: an average of 1 year
Change of disease extent in CT imaging
Emphysema index (0-100, higher values representing worse outcome)
Measured: an average of 1 year
Change in lung function
FEV1 (forced expiratory volume at one second, 10-150 %, lower values representing worse outcome)
Measured: an average of 1 year
Change in symptom scor
St. George's Respiratory Questionnaire score (0-100, higher values representing worse outcome)
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start25 Jan 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, SMG-SNU Boramae Medical Center, National Medical Center, Seoul, KangWon National University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813810
- Sponsor's protocol ID
- Air_pollution_cohort
- Status last verified
- Dec 2018
- First submitted
- 23 Dec 2018
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Air Pollution on Chronic Respiratory Diseases: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03813810
- Acronym / sponsor ID
- Air_pollution_cohort
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, SMG-SNU Boramae Medical Center, National Medical Center, Seoul, KangWon National University Hospital
- Study start
- 25 Jan 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 23 Jan 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.
The aim of this study is to evaluate the impact of air pollution on the occurrence and clinical course of chronic respiratory diseases, and discover new biomarkers from various devices such as CT images that can indicate the process and amount of lung damage caused by air pollution.
Accordingly, the investigators have designed an prospective cohort with enrollment of normal people and patients with chronic respiratory diseases of three different categories (chronic obstructive pulmonary disease, asthma, idiopathic pulmonary fibrosis). Participants will be followed up for a period of one year, with evaluation of the clinical course of the respiratory disease and exposure to air pollution.
Detailed description
Normal people (n=90) and patients with chronic respiratory diseases (chronic obstructive pulmonary disease, asthma, idiopathic pulmonary fibrosis, n=90 for each disease) will be enrolled at 5 different institutions in South Korea and followed up for one year. Inspiratory-expiratory CTs and tests including physical examination and blood/urine tests would be performed at the time of enrollment and the time at completion of the follow up period for each participant. Participants would be checked for the residency and working places, as well as checked for the amount of air pollution exposure using a wearable measurement device for 5 days during the study period ( time at enrollment / 3 months / 6 months / 9 months / time at completion). The device would cause no effect on usual daily life or the medical status of the participant. The clinical course such as occurrence of disease, acute exacerbation, decline of lung function, imaging status, mortality would be evaluated as well as the exposure of air pollution for each individual.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal | – | Other: NonPeople without any chronic pulmonary diseases. |
| Chronic obstructive pulmonary disease | – | Other: NonPatients with chronic obstructive pulmonary disease. |
| Asthma | – | Other: NonPatients with asthma |
| Idiopathic pulmonary fibrosis | – | Other: NonPatients with idiopathic pulmonary fibrosis |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal adults and adult patients with chronic respiratory disease (chronic obstructive pulmonary disease, asthma, idiopathic pulmonary fibrosis)
Key inclusion criteria (4 listed)
- Normal: People with no lung lesions in chest X-ray and St. George's Respiratory Questionnaire score <25, and post bronchodilator FEV1/FVC (forced expiratory volume at one second/forced vital capacity) >= 0.7 and FEV1 >= 80% and FVC >= 80%.
- Chronic obstructive pulmonary disease: Patients with over 10 pack-years of smoking history and post bronchodilator FEV1/FVC <0.7 and FEV1 < 80%, and no other reason for decline of lung function.
- Asthma: Patients with FEV1/FVC < 0.85 and increase in over 12% and 200mL of FEV1 by bronchodilator inhalation. Patients with P20 < 16mg/dL by bronchial provocation test.
- Idiopathic pulmonary fibrosis: Shows usual interstitial pneumonia according to chest CT and has no other reasons such as systematic diseases or medication history.
Key exclusion criteria (3 listed)
- Subjects who refused for enrollment in the study
- Subjects who experienced an acute exacerbation within 1 month.
- Subjects under age of 19.
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 |
|---|---|---|
| NonThere would be no interventions. Only measurements will be performed. | Other | Asthma, Chronic obstructive pulmonary disease, Idiopathic pulmonary fibrosis, Normal |
Primary outcome
Rate of mortality
Time frame: an average of 1 year
Events of mortality through study completion
Rate of acute exacerbations
Time frame: an average of 1 year
Events of acute exacerbations through study completion
Change of disease extent in CT imaging
Time frame: an average of 1 year
Emphysema index (0-100, higher values representing worse outcome)
Change in lung function
Time frame: an average of 1 year
FEV1 (forced expiratory volume at one second, 10-150 %, lower values representing worse outcome)
Change in symptom scor
Time frame: an average of 1 year
St. George's Respiratory Questionnaire score (0-100, higher values representing worse outcome)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Asthma, run by Seoul National University Hospital.
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 4 inclusion and 3 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 23 Jan 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?
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?
Rate of mortality (time frame: an average of 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2019.