Small Bioactive Molecules in Early COPD Diseases

NCT04950023 | Unknown

• 1 other identifier: LM2021083
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Blood samples

  The 1st year and the 3rd year of follow-up

• CT

  The 1st year and the 3rd year of follow-up

• Exhaled breath condensate

  The 1st year and the 3rd year

• Exhaled hydrogen sulfide and nitric oxide

  The 1st year and the 3rd year

• Pulmonary tissue

  The 1st year patients are enrolled

Study Arms (2)

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.

Eligibility Criteria

• Age: Up to 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \. \<60 years old;
• \. Smoking ≥ 10 pack years.
• \. 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).

You may not qualify if:

• \. With other known chronic lung diseases, including bronchiectasis, interstitial pulmonary disease, tuberculosis, and pulmonary vascular disease (CTEPH).
• \. With severe pleural disease and/or lesions of the sternum or ribs.
• \. 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.
• \. Suffering from severe cognitive impairment.
• \. With active tuberculosis or are taking anti-tuberculosis treatment.
• \. Pregnancy or lactation.
• \. Previous lung surgery.
• \. Acute upper and lower respiratory system infection within 4 weeks.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, 100080, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 29406779 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood cells and/or pulmonary tissue.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yahong Chen, PHD

CONTACT

+8601082266699; chenyahong@vip.sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 2, 2021
• Study Start: May 11, 2021
• Primary Completion: May 11, 2022
• Study Completion: May 11, 2024
• Last Updated: July 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)