Personalized Prediction Strategy for Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03240315
• Other study ID #: 201604020012
• Secondary ID: 2017YFC1310600
• Status: Active, not recruiting
• Start date: August 1, 2016
• Est. completion date: September 2021

Study information

• Verified date: February 2021
• Source: Guangzhou Institute of Respiratory Disease
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: September 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
China	Guangzhou Institute of Respiratory Health,The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Guangzhou Institute of Respiratory Disease	Guangzhou Science and Technology Innovation Commission,China, The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Developing new protein chips for AECOPD	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.	3 years
Secondary	Detection of immune repertoire in COPD/AECOPD	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 years
Secondary	Pathogenic microorganism and drug resistance monitoring for COPD exacerbation	Dynamics of pathogenic microorganism and drug resistance in natural course of COPD will be investigated by using the metagenome technique and the culture technique.	3 years