Effects of Neutrophil Extracellular Traps and Damage-associated Molecular Pattern Molecules on Long Term Use of Macrolides in Adults With Chronic Respiratory Disease

Chronic Respiratory Disease Clinical Trial

Official title:

Effects of Neutrophil Extracellular Traps and Damage-associated Molecular Pattern Molecules on Long Term Use of Macrolides in Adults With Chronic Respiratory Disease：A Prospective Observational Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05575726
• Other study ID #: NFEC-2021-230
• Status: Recruiting
• Start date: August 1, 2021
• Est. completion date: August 1, 2024

Study information

• Verified date: December 2021
• Source: Nanfang Hospital of Southern Medical University
• Contact: Haijin Zhao, M.D
• Phone: 13711261757
• Email: 157975178[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to investigate the effects of neutrophil extracellular traps and damage-associated molecular pattern molecules on long term use of macrolides in adults with chronic respiratory disease.

Description:

This study is a prospective, observational, non-interventional cohort study to explore investigate the effects of neutrophil extracellular traps and damage-associated molecular pattern molecules on long term use of macrolides in adults with chronic respiratory disease.The study subjects were adult patients with chronic respiratory disease who met the inclusion criteria in the outpatient department from August 2021 to August 2023. A face-to-face questionnaire survey was conducted. ACT score was used for asthma control evaluation. Baseline data such as pulmonary function, FeNO, blood routine, induced sputum cell count, etc. were obtained. The use of hormones and other drugs was recorded. Inflammatory biomarkers were detected. 20ml venous blood was drawn to extract neutrophils to detect the expression of neutrophil extracellular traps and RT-PCR and ELISA were used to detect the expression of DAMPs. The total study duration was 2 years, with telephone visits every 3 months to assess chronic respiratory disease control and record subject compliance, unscheduled outpatient, emergency, and inpatient status.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 1)Age = 18 years; 2)Gender: not limited; 3)Diagnosis of asthma according to GINA guidelines (version 2021). 4)COPD was diagnosed according to GOLD guidelines (version 2021). 5)ACOS was diagnosed according to the consensus criteria for asthma-chronic obstructive pulmonary overlap syndrome (version 2021).

Exclusion Criteria:

• 1) Acute heart failure, severe organ failure, malignant tumors; 2) Other lung diseases such as pulmonary infection,pulmonary hypertension,tumor which seriously affect lung function, sputum cell classifi cation and other test results; 3) Pregnancy and lactation; 4) Recent surgery history.

Related Conditions & MeSH terms

• Chronic Respiratory Disease
• Respiration Disorders
• Respiratory Tract Diseases

Locations

Country	Name	City	State
China	Haijin Zhao	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Neutrophil Extracellular Traps and Damage-associated Molecular Pattern Molecules in 2 Years	Using elisa to measure e-DNA and HMGB-1 concentrations in sputum from patients.; Change=(Baseline concentrations -2 Years concentrations )	baseline and 2years