Clinical trial NCT04950023: Small Bioactive Molecules in Early COPD Diseases
Official title: Role of Small Bioactive Molecules in the Progression of Early COPD Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 550
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive eligible patients from Peking University Third Hospital will be enrolled.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: lung function
timeFrame: Lung function will be tested at the 1st year, the 2nd year and the 3rd year.
Secondary outcomes:
measure: Blood samples
timeFrame: The 1st year and the 3rd year of follow-up
measure: CT
timeFrame: The 1st year and the 3rd year of follow-up
measure: Exhaled breath condensate
timeFrame: The 1st year and the 3rd year
measure: Exhaled hydrogen sulfide and nitric oxide
timeFrame: The 1st year and the 3rd year
measure: Pulmonary tissue
timeFrame: The 1st year patients are enrolled
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
References:
citation: 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.