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Clinical Trials/NCT05575726
NCT05575726
Unknown
Not Applicable

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.

Nanfang Hospital, Southern Medical University1 site in 1 country300 target enrollmentAugust 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Respiratory Disease
Sponsor
Nanfang Hospital, Southern Medical University
Enrollment
300
Locations
1
Primary Endpoint
Change from Baseline in Neutrophil Extracellular Traps and Damage-associated Molecular Pattern Molecules in 2 Years
Last Updated
3 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
August 1, 2021
End Date
August 1, 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

  • 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.

Outcomes

Primary Outcomes

Change from Baseline in Neutrophil Extracellular Traps and Damage-associated Molecular Pattern Molecules in 2 Years

Time Frame: baseline and 2years

Using elisa to measure e-DNA and HMGB-1 concentrations in sputum from patients. Change=(Baseline concentrations -2 Years concentrations )

Study Sites (1)

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