NCT04960410

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2017

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 13, 2021

Completed
Last Updated

July 13, 2021

Status Verified

July 1, 2021

Enrollment Period

4 months

First QC Date

July 4, 2021

Last Update Submit

July 4, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Frequency of acute exacerbations

    Frequency of acute exacerbations

    1 year incidence rate

Study Arms (2)

Low air pollution

Combination Product: Types and exposure of different air pollutants

High air pollution

Combination Product: Types and exposure of different air pollutants

Interventions

Types and exposure of different air pollutants in COPD patients' living and working environment

High air pollutionLow air pollution

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stable chronic obstructive pulmonary disease (COPD) patients

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yahong Chen, Dr.

    Peking University Third Hospital

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

July 4, 2021

First Posted

July 13, 2021

Study Start

January 1, 2017

Primary Completion

April 23, 2017

Study Completion

December 30, 2018

Last Updated

July 13, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share