Chronic Respiratory DiseaseNCT05575726
Effects of Neutrophil Extracellular Traps and Damage-associated Molecular Pattern Molecules on Long Term Use of Macrolides in Adults With Chronic Respiratory Disease
An observational study of Chronic Respiratory Disease, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Respiratory Disease
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults With Chronic Respiratory Disease.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Haijin Zhao
Guangzhou, Guangdong, 510515
Haijin Zhao, M.D., 13711261757, 157975178@qq.com
About this study
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.
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.
Read the 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.
- Conditions
- Chronic Respiratory Disease
- Keywords
- neutrophil extracellular traps, damage-associated molecular pattern molecules, macrolides
What is being measured
The primary outcome is the main question the study is designed to answer.
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 )
Measured: baseline and 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start1 Aug 2021
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Respiratory DiseaseStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haijin Zhao, M.D, Study chair, Laboratory of Chronic Airway Diseases，NanfangH.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575726
- Sponsor's protocol ID
- NFEC-2021-230
- Status last verified
- Dec 2021
- First submitted
- 7 Oct 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05575726
- Acronym / sponsor ID
- NFEC-2021-230
- Conditions
- Chronic Respiratory Disease
- Keywords
- neutrophil extracellular traps, damage-associated molecular pattern molecules, macrolides
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults With Chronic Respiratory Disease.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 )
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haijin Zhao, M.D study chair
Laboratory of Chronic Airway Diseases，NanfangH.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Respiratory Disease, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haijin Zhao, M.D (13711261757, 157975178@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Neutrophil Extracellular Traps and Damage-associated Molecular Pattern Molecules in 2 Years (time frame: baseline and 2years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.