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Trial record 2 of 3445 for:    Respiratory Disease | Recruiting, Not yet recruiting, Available Studies | "Lung Diseases"

Personalized Prediction Strategy for Acute Exacerbation of Chronic Obstructive Pulmonary Disease

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ClinicalTrials.gov Identifier: NCT03240315
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : August 7, 2017
Sponsor:
Collaborators:
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou Science and Technology Innovation Commission,China
Information provided by (Responsible Party):
Fengyan Wang, Guangzhou Institute of Respiratory Disease

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.

Condition or disease
Pulmonary Disease, Chronic Obstructive

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Establishment of Individualized Prediction System for Acute Exacerbation of Chronic Obstructive Pulmonary Disease Based on Cloud Platform
Actual Study Start Date : August 1, 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Group/Cohort
COPD subjects
Subjects with GOLD stage I-IV COPD



Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
Whole blood, serum, plasma,sputum


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
COPD subjects in China
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03240315


Contacts
Contact: Fengyan Wang, MD/Ph.D +8613265116055 wangfengyan_@126.com
Contact: Zhenyu Liang, MD/Ph.D +8613560157649 490458234@qq.com

Locations
China, Guangdong
Guangzhou Institute of Respiratory Disease,The First Affiliated Hospital of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Rongchang Chen, MD/Ph.D    +862083062870    chenrc@vip.163.com   
Sponsors and Collaborators
Guangzhou Institute of Respiratory Disease
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou Science and Technology Innovation Commission,China
Investigators
Study Director: Rongchang Chen, MD/Ph.D Guangzhou Institute of Respiratory Disease,The First Affiliated Hospital of Guangzhou Medical University,China

Responsible Party: Fengyan Wang, Principal Investigator, Guangzhou Institute of Respiratory Disease
ClinicalTrials.gov Identifier: NCT03240315     History of Changes
Other Study ID Numbers: 201604020012
2017YFC1310600 ( Other Grant/Funding Number: Ministry of Science and Technology of the People's Republic of China )
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes