Small Bioactive Molecules in Early COPD Diseases

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT04950023
• Lead Sponsor: Peking University Third Hospital

Brief Summary

To study the predictors contribute to the progression of COPD by follow-up of patients with early COPD and analyze their changes in bioactive molecular, exhaled gas, CT image, lung function, patient's symptoms and life quality.

Detailed Description

A research found that nearly 40% of patients with chronic respiratory symptoms who showed significant airway inflammation (airway wall thickening and/or lung structure destruction (emphysema) on chest CT had advanced COPD within 5 years, although their current lung function failed to meet diagnostic criteria for COPD. Current spirometry-based diagnostic methods are not the best predictors of COPD progression and death. CT indicated emphysema and airway inflammation were recognized as better predictors of disease progression and mortality. Based on a large cohort study, some scholars proposed the concept of "early COPD", focusing on people under the age of 50, smoking for more than 10 pack years, having one of the manifestations of early airflow limitation, abnormal chest CT, and rapid decline of FEV1, to study the mechanism of disease progression and early intervention methods.\[4\] In this study, we enroll participants with early COPD symptoms, to detect the progression of COPD with 3 years of follow-up. The predictors of disease progression and variants of bioactive molecular were analyzed, so as to clarify the progressive mechanism of COPD.

Study Timeline

• Study Start: 2021-05-11
• Status Verified: 2021-06
• Study First Submitted: 2021-06-29
• Study First Submitted QC: 2021-06-29
• Study First Posted: 2021-07-02
• Last Update Submitted: 2021-07-08
• Last Update Posted: 2021-07-14
• Primary Completion: 2022-05-11
• Study Completion: 2024-05-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

• 1. <60 years old;

  2. Smoking ≥ 10 pack years.

  3. With any of the following anomalies: a. Post-bronchodilator FEV1/FVC< 0.7. b. CT image abnormalities: emphysema, air trapping or bronchial wall thickening; c.Rapid decrease of FEV1 (>60 ml/yr).

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Exclusion Criteria

• 1. With other known chronic lung diseases, including bronchiectasis, interstitial pulmonary disease, tuberculosis, and pulmonary vascular disease (CTEPH).

  2. With severe pleural disease and/or lesions of the sternum or ribs.

  3. Suffering from serious uncontrolled other systemic diseases, including chest and abdominal surgery, heart attack (angina pectoris, myocardial infarction, malignant arrhythmia, etc.) and cerebrovascular disease (stroke) within 3 months, as well as kidney disease (AKI), cirrhosis, and any malignant tumor except lung cancer.

  4. Suffering from severe cognitive impairment.

  5. With active tuberculosis or are taking anti-tuberculosis treatment.

  6. Pregnancy or lactation.

  7. Previous lung surgery.

  8. Acute upper and lower respiratory system infection within 4 weeks.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
lung function	Lung function will be tested at the 1st year, the 2nd year and the 3rd year.	Patients' lung function will be tested to identify air flow decrease in the early COPD group and the control group.

Secondary Outcome Measures

Name	Time	Method
Blood samples	The 1st year and the 3rd year of follow-up	Collect venous blood to detect cytokines and other molecular.
CT	The 1st year and the 3rd year of follow-up	Both inspiration phase and expiration phase are required
Exhaled breath condensate	The 1st year and the 3rd year	Using commercially available exhaled breath condensate collection
Exhaled hydrogen sulfide and nitric oxide	The 1st year and the 3rd year	Using breath analyzer to detect real-time release
Pulmonary tissue	The 1st year patients are enrolled	Pulmonary tissue will be obtained from patients who are about to undergo resection, for example, COPD patients with lung cancer.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China