- ICH GCP
- US Clinical Trials Registry
- 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
October 7, 2022 updated by: Nanfang Hospital of Southern Medical University
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.
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.
Study Overview
Status
Recruiting
Conditions
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 Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Haijin Zhao, M.D
- Phone Number: 13711261757
- Email: 157975178@qq.com
Study Contact Backup
- Name: Yuemao Li, M.D.
- Phone Number: 13302890431
- Email: 3270674371@qq.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510515
- Recruiting
- Haijin Zhao
-
Contact:
- Haijin Zhao, M.D.
- Phone Number: 13711261757
- Email: 157975178@qq.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adults With Chronic Respiratory Disease.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 ) |
baseline and 2years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Haijin Zhao, M.D, Laboratory of Chronic Airway Diseases,NanfangH.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2021
Primary Completion (Anticipated)
August 1, 2023
Study Completion (Anticipated)
August 1, 2024
Study Registration Dates
First Submitted
October 7, 2022
First Submitted That Met QC Criteria
October 7, 2022
First Posted (Actual)
October 12, 2022
Study Record Updates
Last Update Posted (Actual)
October 12, 2022
Last Update Submitted That Met QC Criteria
October 7, 2022
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NFEC-2021-230
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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