Personalized Prediction Strategy for Acute Exacerbation of Chronic Obstructive Pulmonary Disease

NCT03240315 | Active Not Recruiting

• 2 other identifiers: 2016040200122017YFC1310600
• Study Type: observational
• Target: 442
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 3-year longitudinal study designed to establish a personalized prediction and prevention system for acute exacerbations of chronic obstructive pulmonary disease (AECOPD). Data will be prospectively collected from patients with chronic obstructive pulmonary disease (COPD) and healthy control participants, including clinical characteristics, pathophysiological parameters, etiological factors, and immunological information. These data will be analyzed using data mining approaches combined with Internet-based technologies.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Establishment of prediction platform for COPD exacerbation

  The patients with chronic obstruction pulmonary disease will be followed up at intervals of 3 months for 3 years by the Modified British Medical Research Council (mMRC) score scale,spirometric analysis, sputum smear,questionnaire and so on. An exacerbation of COPD was diagnosed according to GOLD guidelines. Time to the first acute exacerbation and average number of acute exacerbations per year in COPD subjects will be record.Research of AECOPD Risk factors based on complex network analysis.Identification and validation of COPD exacerbations risk stratification and predictive markers based on data mining.

  3 years

Secondary Outcomes (3)

• Developing new protein chips for AECOPD

  3 years

• Detection of immune repertoire in COPD/AECOPD

  3 years

• Pathogenic microorganism and drug resistance monitoring for COPD exacerbation

  3 years

Study Arms (2)

COPD subjects

Subjects with GOLD stage I-IV COPD

Healthy control subjects

Ages 40 to 90, with no history of lung disease and no history of acute illness or medication use within the past month.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

COPD subjects in China

You may qualify if:

• Patients was diagnosed as COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines older than 40 years old.
• A signed and dated written informed consent is obtained prior to participation.
• Able to comply with the requirements of the protocol and be available for study visits over 3 years.

You may not qualify if:

• Known respiratory disorders, or disorders identified at screening/visit 1 (including identification on the first CT scan), other than COPD (e.g.: lung cancer, sarcoidosis, tuberculosis, lung fibrosis, cystic fibrosis)
• Known history of significant inflammatory disease, other than COPD (e.g. rheumatoid arthritis and Lupus)
• Known to be severely alpha-1-antitrypsin deficient
• Has experienced a moderate or severe exacerbation (requiring oral corticosteroid, antibiotics or hospitalisation) within the last 4 weeks
• Having undergone lung surgery (e.g. lung reduction, lung transplant)
• Have cancer or have had cancer in the 5 years prior to study entry
• Having received a blood transfusion in the 4 weeks prior to study start
• Inability to walk
• Taking part in a blinded drug study

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• Guangzhou Science and Technology Innovation Commission,China: collaborator

Study Sites (1)

Guangzhou Institute of Respiratory Health,The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

Location

Related Publications (2)

• Li X, Feng S, Yang Y, Liang Z, Song A, Chen J, Guo Z, Chen Z, Miao C, Yang H, He W, Zhou Z, Drummond MB, Chen R, Wang F. Association Between Airway Mucus Plugs and Risk of Moderate-to-Severe Exacerbations in Patients With COPD: Results From a Chinese Prospective Cohort Study. Chest. 2025 Sep;168(3):627-638. doi: 10.1016/j.chest.2025.03.026. Epub 2025 Apr 8.

  PMID: 40210091 DERIVED

• Cass SP, Yang Y, Xiao J, McGrath JJC, Fantauzzi MF, Thayaparan D, Wang F, Liang Z, Long F, Stevenson CS, Chen R, Stampfli MR. Current smoking status is associated with reduced sputum immunoglobulin M and G expression in COPD. Eur Respir J. 2021 Feb 4;57(2):1902338. doi: 10.1183/13993003.02338-2019. Print 2021 Feb. No abstract available.

  PMID: 32883677 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, plasma,sputum

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rongchang Chen, MD/Ph.D

  Guangzhou Institute of Respiratory Health,The First Affiliated Hospital of Guangzhou Medical University,China

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 7, 2017
• Study Start: August 1, 2016
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)