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NCT Number: NCT03240315

Personalized Prediction Strategy for Acute Exacerbation of Chronic Obstructive Pulmonary Disease

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.

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Guangzhou, Guangdong, 510120, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • A COPD subject will not be eligible for inclusion in this study if any of the following criteria apply:
  • 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
  • Having therapy with systemic corticosteroids at inclusion.

Treatment and study plan

Primary outcomes

  1. Establishment of prediction platform for COPD exacerbation

    Time frame: 3 years

    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.

Secondary outcomes

  1. Developing new protein chips for AECOPD

    Time frame: 3 years

    Systemic and airway autoantibody profiles and cytokine profiles will be measured using commercial multiplex bead-based assay to screen out a set of ideal AECOPD-related markers.

  2. Detection of immune repertoire in COPD/AECOPD

    Time frame: 3 years

    Immune status of COPD patients will be investigated by using the immune repertoire technique and its relationship with the pathophysiology of AECOPD will be identified.

  3. Pathogenic microorganism and drug resistance monitoring for COPD exacerbation

    Time frame: 3 years

    Dynamics of pathogenic microorganism and drug resistance in natural course of COPD will be investigated by using the metagenome technique and the culture technique.

Sponsors and collaborators

Lead sponsor

Guangzhou Institute of Respiratory Disease

Other

Collaborators

  • Guangzhou Science and Technology Innovation Commission,China
  • The First Affiliated Hospital of Guangzhou Medical University

Registry information

Official study title

Establishment of Individualized Prediction System for Acute Exacerbation of Chronic Obstructive Pulmonary Disease Based on Cloud Platform

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2017
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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