NCT02657525

Brief Summary

The purpose of this study is to investigate the demographic characteristics, clinical features, diagnoses and treatments of AECOPD hospitalized patients in China, and disease prognosis and its economic burden.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
7,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
unknown

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, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

February 4, 2016

Status Verified

February 1, 2016

Enrollment Period

11 months

First QC Date

January 14, 2016

Last Update Submit

February 3, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • In-hospital mortality

    All-cause and cause-specific mortality will be described.

    12 months

  • Readmission

    Readmission rate caused by AECOPD within 1 month after discharged from hospital.

    12 months

Secondary Outcomes (4)

  • All-cause and cause-specific mortality

    3 years

  • Recurrence of acute exacerbation of COPD

    3 years

  • Lung function and quality of life assessment

    3 years

  • Healthcare costs

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

AECOPD-IRS plans to enroll 7600 hospitalized patients (≥ 18 years old with main diagnosis as AECOPD). Sample size estimation is based on estimated mortality of AECOPD hospitalized patients (\~5%). Study patients will be recruited from 40-60 hospitals across China,each hospital will recruit 152-190 patients. Hospital selection follows a multi-stage sampling strategy.

You may qualify if:

  • ≥18 years of age; hospitalized patients with main diagnosis as AECOPD.

You may not qualify if:

  • Patients diagnosed as active pulmonary tuberculosis, or acute left heart failure; Patients participating in clinical trials or intervention studies of drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Niu Y, Niu H, Meng X, Zhu Y, Ren X, He R, Wu H, Yu T, Zhang Y, Kan H, Chen R, Yang T, Wang C. Associations Between Air Pollution and the Onset of Acute Exacerbations of COPD: A Time-Stratified Case-Crossover Study in China. Chest. 2024 Nov;166(5):998-1009. doi: 10.1016/j.chest.2024.05.030. Epub 2024 Jun 19.

  • He R, Wang Y, Ren X, Huang K, Lei J, Niu H, Li W, Dong F, Li B, Yang T, Wang C. Associations of medication regimen complexity with medication adherence and clinical outcomes in patients with chronic obstructive pulmonary disease: a prospective study. Ther Adv Respir Dis. 2023 Jan-Dec;17:17534666231206249. doi: 10.1177/17534666231206249.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Dr.

Study Record Dates

First Submitted

January 14, 2016

First Posted

January 18, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2016

Study Completion

January 1, 2020

Last Updated

February 4, 2016

Record last verified: 2016-02