Small Bioactive Molecules in Early COPD Diseases

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Role of Small Bioactive Molecules in the Progression of Early COPD Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04950023
• Other study ID #: LM2021083
• Status: Recruiting
• Start date: May 11, 2021
• Est. completion date: May 11, 2024

Study information

• Verified date: June 2021
• Source: Peking University Third Hospital
• Contact: Yahong Chen, PHD
• Phone: +8601082266699
• Email: chenyahong[@]vip.sina.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: May 11, 2024
• Est. primary completion date: May 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 60 Years

Eligibility

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).

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Martinez FJ, Han MK, Allinson JP, Barr RG, Boucher RC, Calverley PMA, Celli BR, Christenson SA, Crystal RG, Fagerås M, Freeman CM, Groenke L, Hoffman EA, Kesimer M, Kostikas K, Paine R 3rd, Rafii S, Rennard SI, Segal LN, Shaykhiev R, Stevenson C, Tal-Singer R, Vestbo J, Woodruff PG, Curtis JL, Wedzicha JA. At the Root: Defining and Halting Progression of Early Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2018 Jun 15;197(12):1540-1551. doi: 10.1164/rccm.201710-2028PP. Erratum in: Am J Respir Crit Care Med. 2018 Dec 1;198(11):1463. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lung function	Patients' lung function will be tested to identify air flow decrease in the early COPD group and the control group.	Lung function will be tested at the 1st year, the 2nd year and the 3rd year.
Secondary	Blood samples	Collect venous blood to detect cytokines and other molecular.	The 1st year and the 3rd year of follow-up
Secondary	CT	Both inspiration phase and expiration phase are required	The 1st year and the 3rd year of follow-up
Secondary	Exhaled breath condensate	Using commercially available exhaled breath condensate collection	The 1st year and the 3rd year
Secondary	Exhaled hydrogen sulfide and nitric oxide	Using breath analyzer to detect real-time release	The 1st year and the 3rd year
Secondary	Pulmonary tissue	Pulmonary tissue will be obtained from patients who are about to undergo resection, for example, COPD patients with lung cancer.	The 1st year patients are enrolled