Impact of Air Pollution on Chronic Respiratory Diseases

Asthma Clinical Trial

Official title:

The Impact of Air Pollution on Chronic Respiratory Diseases: a Prospective Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03813810
• Other study ID #: Air_pollution_cohort
• Status: Not yet recruiting
• Start date: January 25, 2019
• Est. completion date: December 2021

Study information

• Verified date: December 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Chronic Obstructive Pulmonary Disease
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Fibrosis
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

Other:
• Non
There would be no interventions. Only measurements will be performed.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Seoul National University Hospital	KangWon National University Hospital, National Medical Center, Seoul, Seoul National University Bundang Hospital, SMG-SNU Boramae Medical Center

Outcome

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