Impact of Air Pollution on Chronic Respiratory Diseases

NCT03813810 | Unknown

• 1 other identifier: Air_pollution_cohort
• Study Type: observational
• Target: 360
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease; Asthma; Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (4)

Normal

People without any chronic pulmonary diseases.

Other: Non

Chronic obstructive pulmonary disease

Patients with chronic obstructive pulmonary disease.

Other: Non

Asthma

Patients with asthma

Other: Non

Idiopathic pulmonary fibrosis

Patients with idiopathic pulmonary fibrosis

Other: Non

Interventions

Non OTHER

There would be no interventions. Only measurements will be performed.

Asthma; Chronic obstructive pulmonary disease; Idiopathic pulmonary fibrosis; Normal

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Seoul National University Bundang Hospital: collaborator
• SMG-SNU Boramae Medical Center: collaborator
• National Medical Center, Seoul: collaborator
• KangWon National University Hospital: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

blood, urine, induced sputum

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma; Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pulmonary Fibrosis; Lung Diseases, Interstitial

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2018
• First Posted: January 23, 2019
• Study Start: January 25, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: January 23, 2019

Record last verified: 2018-12