Personalized Prediction Strategy for Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Guangzhou Institute of Respiratory Disease

Status: Active, not recruiting

Conditions: Pulmonary Disease, Chronic Obstructive

Study type: Observational

Funder types: Other

Identifiers

NCT03240315

2017YFC1310600 (Other Grant/Funding Number)

201604020012

Details and patient eligibility

About

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.

Enrollment: 442 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

442 participants in 2 patient groups

COPD subjects

Description:

Subjects with GOLD stage I-IV COPD

Healthy control subjects

Description:

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