Clinical trial NCT05575726: Effects of Neutrophil Extracellular Traps and Damage-associated Molecular Pattern Molecules on Long Term Use of Macrolides in Adults With Chronic Respiratory Disease
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Respiratory Disease
Keywords: neutrophil extracellular traps
damage-associated molecular pattern molecules
macrolides
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults With Chronic Respiratory Disease.

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.

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:

* 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.

Primary outcomes:
measure: Change from Baseline in Neutrophil Extracellular Traps and Damage-associated Molecular Pattern Molecules in 2 Years
timeFrame: baseline and 2years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Haijin Zhao
state: Guangdong
Study officials:
affiliation: Laboratory of Chronic Airway Diseases，NanfangH.
name: Haijin Zhao, M.D
role: STUDY_CHAIR
References: