NCT05575726

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

October 12, 2022

Status Verified

December 1, 2021

Enrollment Period

2 years

First QC Date

October 7, 2022

Last Update Submit

October 7, 2022

Conditions

Chronic Respiratory Disease

Keywords

neutrophil extracellular trapsdamage-associated molecular pattern moleculesmacrolides

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults With Chronic Respiratory Disease.

You may qualify if:

  • ）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).

You may not qualify if:

  • \) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haijin Zhao

Guangzhou, Guangdong, 510515, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

sputum

Study Officials

  • Haijin Zhao, M.D

    Laboratory of Chronic Airway Diseases，NanfangH.

    STUDY CHAIR

Central Study Contacts

Haijin Zhao, M.D

CONTACT

13711261757157975178@qq.com

Yuemao Li, M.D.

CONTACT

133028904313270674371@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2022

First Posted

October 12, 2022

Study Start

August 1, 2021

Primary Completion

August 1, 2023

Study Completion

August 1, 2024

Last Updated

October 12, 2022

Record last verified: 2021-12

Locations

CN(1)