Impact of Air Pollution on Chronic Respiratory Diseases

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease; Asthma; Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Other: Non

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 Type: Observational
• Enrollment (Anticipated): 360

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Normal adults and adult patients with chronic respiratory disease (chronic obstructive pulmonary disease, asthma, idiopathic pulmonary fibrosis)

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Subjects who refused for enrollment in the study
• Subjects who experienced an acute exacerbation within 1 month.
• Subjects under age of 19.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal; People without any chronic pulmonary diseases.	Other: Non; There would be no interventions. Only measurements will be performed.
Chronic obstructive pulmonary disease; Patients with chronic obstructive pulmonary disease.	Other: Non; There would be no interventions. Only measurements will be performed.
Asthma; Patients with asthma	Other: Non; There would be no interventions. Only measurements will be performed.
Idiopathic pulmonary fibrosis; Patients with idiopathic pulmonary fibrosis	Other: Non; There would be no interventions. Only measurements will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of mortality	Events of mortality through study completion	an average of 1 year
Rate of acute exacerbations	Events of acute exacerbations through study completion	an average of 1 year
Change of disease extent in CT imaging	Emphysema index (0-100, higher values representing worse outcome)	an average of 1 year
Change in lung function	FEV1 (forced expiratory volume at one second, 10-150 %, lower values representing worse outcome)	an average of 1 year
Change in symptom scor	St. George's Respiratory Questionnaire score (0-100, higher values representing worse outcome)	an average of 1 year

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Seoul National University Bundang Hospital; SMG-SNU Boramae Medical Center; KangWon National University Hospital; National Medical Center, Seoul

Study record dates

Study Major Dates

• Study Start (Anticipated): January 25, 2019
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: December 23, 2018
• First Submitted That Met QC Criteria: January 21, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 21, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: Air_pollution_cohort

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No