Small Bioactive Molecules in Early COPD Diseases

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease

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 Type: Observational
• Enrollment (Anticipated): 550

Contacts and Locations

• Study Contact: Name: Yahong Chen, PHD; Phone Number: +8601082266699; Email: chenyahong@vip.sina.com

Study Locations

• China
  • Beijing, China, 100080
    • Recruiting
    • Peking University Third Hospital
    • Contact: Yahong Chen, PHD; Phone Number: +8601082266699; Email: chenyahong@vip.sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 60 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive eligible patients from Peking University Third Hospital will be enrolled.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
early COPD; 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).
Control; 1) <60 years old; 2) Pre-bronchodilator FEV1/FVC≥70% and FEV1 ≥ 80% predicted; 3) no exposure to harmful factors such as cigarettes and dust pollution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood samples	Collect venous blood to detect cytokines and other molecular.	The 1st year and the 3rd year of follow-up
CT	Both inspiration phase and expiration phase are required	The 1st year and the 3rd year of follow-up
Exhaled breath condensate	Using commercially available exhaled breath condensate collection	The 1st year and the 3rd year
Exhaled hydrogen sulfide and nitric oxide	Using breath analyzer to detect real-time release	The 1st year and the 3rd year
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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Publications and helpful links

General Publications

• Martinez FJ, Han MK, Allinson JP, Barr RG, Boucher RC, Calverley PMA, Celli BR, Christenson SA, Crystal RG, Fageras 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. No abstract available. Erratum In: Am J Respir Crit Care Med. 2018 Dec 1;198(11):1463.

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2021
• Primary Completion (Anticipated): May 11, 2022
• Study Completion (Anticipated): May 11, 2024

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Actual): July 14, 2021
• Last Update Submitted That Met QC Criteria: July 8, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: LM2021083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No