Real Time Early Warning Model and Mobile Medical Assistant System for the Impact of Air Pollution on AECOPD Disease

Real Time Early Warning Model and Mobile Medical Assistant System for the Impact of Air Pollution on Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Objective to establish a real-time early warning model of acute exacerbation of chronic obstructive pulmonary disease (COPD) caused by air pollution, and develop the corresponding mobile medical assistant system. Through the cross fusion of existing information technology and medical research results, an auxiliary medical system is formed for information recording, tracking tools, early warning model and clinical diagnosis of patients with COPD.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Combination product: Types and exposure of different air pollutants

Detailed Description

Objective to establish a real-time early warning model of acute exacerbation of chronic obstructive pulmonary disease (COPD) caused by air pollution, and develop the corresponding mobile medical assistant system. Through the cross fusion of existing information technology and medical research results, an auxiliary medical system is formed for information recording, tracking tools, early warning model and clinical diagnosis of patients with COPD.

• Study Type: Observational
• Enrollment (Actual): 56

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Stable chronic obstructive pulmonary disease (COPD) patients

Description

Inclusion Criteria:

• Patients aged > 40 and < 80 years with post-bronchodilator FEV1/ forced vital capacity (FVC) < 0.7 and percentage predicted of FEV1>30%, who were no exacerbation of symptoms in the 6 weeks preceding the study, were included in the study.

Exclusion Criteria:

• Patients who were diagnosed with other chronic respiratory diseases, including bronchial asthma, bronchiectasis and lung abscess.
• Patients with near-terminal illness, congestive heart failure (NYHA III-IV), or cannot record CAT score timely were excluded.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Low air pollution	Combination product: Types and exposure of different air pollutants; Types and exposure of different air pollutants in COPD patients' living and working environment
High air pollution	Combination product: Types and exposure of different air pollutants; Types and exposure of different air pollutants in COPD patients' living and working environment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of acute exacerbations	Frequency of acute exacerbations	1 year incidence rate

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Beihang University
• Investigators: Study Director: Yahong Chen, Dr., Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): April 23, 2017
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: July 4, 2021
• First Submitted That Met QC Criteria: July 4, 2021
• First Posted (Actual): July 13, 2021

Study Record Updates

• Last Update Posted (Actual): July 13, 2021
• Last Update Submitted That Met QC Criteria: July 4, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: LM2018072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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