Clinical trial NCT03240315: Personalized Prediction Strategy for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Official title: Establishment of Individualized Prediction System for Acute Exacerbation of Chronic Obstructive Pulmonary Disease Based on Cloud Platform
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Guangzhou Medical University
name: Guangzhou Science and Technology Innovation Commission,China
First posted: 2017-08-07
Enrollment: 400
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: COPD subjects in China

Brief summary: This is a 3 year longitudinal study to establish a personalized prediction and prevention system for acute exacerbation of chronic obstructive pulmonary disease（AECOPD). Data will be collected which contained with clinical, pathophysiology, etiology and immunology information of chronic obstructive pulmonary disease(COPD) patients and analyzed by data mining combined with Internet technology.


Eligibility criteria: 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.

Primary outcomes:
measure: Establishment of prediction platform for COPD exacerbation
timeFrame: 3 years
Secondary outcomes:
measure: Developing new protein chips for AECOPD
timeFrame: 3 years
measure: Detection of immune repertoire in COPD/AECOPD
timeFrame: 3 years
measure: Pathogenic microorganism and drug resistance monitoring for COPD exacerbation
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Institute of Respiratory Health,The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: Guangzhou Institute of Respiratory Health,The First Affiliated Hospital of Guangzhou Medical University,China
name: Rongchang Chen, MD/Ph.D
role: STUDY_DIRECTOR
References:
citation: 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.