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

Sponsor
Nanfang Hospital of Southern Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05575726
Collaborator
(none)
300
1
36
8.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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.
    Actual Study Start Date :
    Aug 1, 2021
    Anticipated Primary Completion Date :
    Aug 1, 2023
    Anticipated Study Completion Date :
    Aug 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline in Neutrophil Extracellular Traps and Damage-associated Molecular Pattern Molecules in 2 Years [baseline and 2years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Haijin Zhao Guangzhou Guangdong China 510515

    Sponsors and Collaborators

    • Nanfang Hospital of Southern Medical University

    Investigators

    • Study Chair: Haijin Zhao, M.D, Laboratory of Chronic Airway Diseases,NanfangH.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nanfang Hospital of Southern Medical University
    ClinicalTrials.gov Identifier:
    NCT05575726
    Other Study ID Numbers:
    • NFEC-2021-230
    First Posted:
    Oct 12, 2022
    Last Update Posted:
    Oct 12, 2022
    Last Verified:
    Dec 1, 2021
    Keywords provided by Nanfang Hospital of Southern Medical University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 12, 2022