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Cohort Study of Airway Microecology and the Pathogenesis and Evolution of Chronic Obstructive Pulmonary Disease

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ClinicalTrials.gov Identifier: NCT04849104
Recruitment Status : Recruiting
First Posted : April 19, 2021
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Brief Summary:
This study will last for 5 years (2021.2.25-2025.12.31). 210 patients (70 cases in each group) will be enrolled in this study. Eight centers in China will participate in the study. The patients will be treated with bronchoscopy alveolar lavage, and 60 ml of bronchoalveolar lavage fluid will be collected for the next-generation sequencing of airway microorganisms. The patients will be followed up for 4 years to observe the changes of lung function, Fractional exhaled nitric oxide (FENO) and clinical symptoms.

Condition or disease
Chronic Obstructive Pulmonary Disease

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Study Type : Observational
Estimated Enrollment : 210 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cohort Study of Airway Microecology and the Pathogenesis and Evolution of Chronic Obstructive Pulmonary Disease
Actual Study Start Date : February 26, 2021
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Group/Cohort
COPD high-risk patients
age <60 years old, long-term smoker (≥10 pack years), CT without macroscopic airway abnormalities and/or mild or moderate emphysema, air retention or bronchial thickening, normal lung function
Early-stage COPD patients

those who are younger than 60 years old, long-term smokers (≥10 pack years) and have any of the following abnormalities:

  1. Forced expiratory volume in the first second/forced vital capacity (FEV1/FVC) <lower limit of normal value (LLN, 80%);
  2. CT abnormalities: abnormal airway and/or emphysema, air retention or bronchial wall thickening;
  3. FEV1 drops rapidly (≥60 mL/year);
patients with mild to moderate COPD
Patients with mild to moderate COPD: age <65 years, FEV1/FVC<70%, FEV1 predicted value ≥50%



Primary Outcome Measures :
  1. Forced vital capacity(FVC) [ Time Frame: 0, 12,24,36,48months ]
    The change of FVC at each time node

  2. Forced expiratory volume in the first second(FEV1) [ Time Frame: 0, 12,24,36,48months ]
    The change of FEV1 at each time node

  3. Forced expiratory rate in the first second (FEV1%=FEV1/FVC) [ Time Frame: 0, 12,24,36,48months ]
    The change of FEV1% at each time node

  4. Exhaled nitric oxide (FENO) [ Time Frame: 0, 12,24,36,48months ]
    The change of FENO at each time node


Secondary Outcome Measures :
  1. breathlessness measurement using the modified British Medical Research Council (mMRC) [ Time Frame: 0, 12, 24, 36, 48months ]
    The change of mMRC at each time node

  2. COPD assessment test (CAT) [ Time Frame: 0, 12, 24, 36, 48months ]
    The change of CAT at each time node


Biospecimen Retention:   Samples Without DNA
60ml bronchoalveolar lavage fluid


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
outpatient or hospitalized patient
Criteria

Inclusion Criteria:

  1. Have the ability to communicate orally or in writing and sign an informed consent form;
  2. Age from 18 to 60 years (the age of patients with mild to moderate COPD <65 years), regardless of gender;
  3. Meet the above-mentioned early diagnosis criteria for high-risk patients with COPD/early-stage COPD/mild to moderate COPD.

Exclusion Criteria:

  1. Patients suffering from any of the following diseases: active tuberculosis, severe bronchiectasis, lung abscess, aspiration pneumonia, lung tumor, non-infectious interstitial lung disease, pulmonary edema, atelectasis, pneumothorax, pleural effusion , Pulmonary embolism, pulmonary eosinophilic infiltration, and pulmonary vasculitis;
  2. Patients with a history of tumors or patients with current tumors;
  3. The patient has severe renal impairment: creatinine clearance rate <30ml/min/1.73m2 or serum creatinine>265μmol/L (>3mg/dL);
  4. Patients suffering from liver disease or severe liver damage: ALT, AST> 2 times the upper limit of normal;
  5. pregnancy;
  6. Severe COPD, FEV1 predicted value ≤50%;
  7. Severe heart disease, such as coronary heart disease, heart failure, etc.;
  8. Severe coagulopathy: INR>1.4, PTT>40s, PLT<150x103 cells
  9. Bronchial Asthma;
  10. Severe alcoholism;
  11. diabetes;
  12. Have used antibiotics within two months,
  13. Used systemic and local hormones;
  14. Cannot sign the informed consent form;

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): NCT04849104


Contacts
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Contact: Junjie Yun, master 021-23271699 ext 5816 379215100@qq.com

Locations
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China, Shanghai
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiaotong University Recruiting
Shanghai, Shanghai, China, 200011
Contact: JunJie Yun, master    23271699 ext 5816    379215100@qq.com   
Sponsors and Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Investigators
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Study Chair: Weining Xiong, doctor Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Publications of Results:
Other Publications:

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Responsible Party: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT04849104    
Other Study ID Numbers: COPD-BALF2021
First Posted: April 19, 2021    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University:
chronic obstructive pulmonary disease
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases