The Value of FeNO in Predicting Airway Eosinophilic Inflammation
NCT ID: NCT04885738
Last Updated: 2021-05-13
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
2052 participants
Study Classification
OBSERVATIONAL
Study Start Date
2021-05-25
Study Completion Date
2022-05-30
Brief Summary
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To investigate and compare the value of FeNO, blood Eos, serum TIgE in predicting the airway eosinophilic inflammationin chronic cough, asthma and COPD.
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Detailed Description
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Cough is the most common complaint in the respiratory department, while asthma and chronic obstructive pulmonary disease(COPD) are two major respiratory disease that seriously endanger human health. The common test to identify the cause and evaluate the therapeutic effect such as induced sputum, pulmonary ventilation function test, bronchial provocation test, etc. are time-consuming and laborious. There is an urgent need for an easily detectable index in the clinic to quickly identify airway eosinophilic inflammation in chronic cough, asthma and COPD, which will provide important guidance for clinical treatment.
As a new marker of airway inflammation, exhaled nitric oxide(FeNO) can reflect eosinophilic airway inflammation. Mean while, FeNO has the advantages of non-invasive, simple operation, time-saving, labor-saving, and good reproducibility, which is suitable for clinical application.
This prospective, multi-center study aims to explore the value of FeNO in predicting airway eosinophilic inflammation and compare it with blood Eos and TLgE in patients with chronic cough, asthma and COPD.
As a new marker of airway inflammation, exhaled nitric oxide(FeNO) can reflect eosinophilic airway inflammation. Mean while, FeNO has the advantages of non-invasive, simple operation, time-saving, labor-saving, and good reproducibility, which is suitable for clinical application.
This prospective, multi-center study aims to explore the value of FeNO in predicting airway eosinophilic inflammation and compare it with blood Eos and TLgE in patients with chronic cough, asthma and COPD.
Conditions
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Biomarkers
Airway Inflammation
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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Chronic Cough
cough as a sole presenting lasted more than 8 weeks; with an age of 18-70years; with a normal chest X-ray; without steroids treatment in the last 4 weeks.
no intervention
Intervention Type
OTHER
For Chronic Cough，follow《Guidelines for the diagnosis and treatment of cough》(2015).
For Asthma, follow GINA For COPD, follow GOLD.
Asthma
classic asthma
no intervention
Intervention Type
OTHER
For Chronic Cough，follow《Guidelines for the diagnosis and treatment of cough》(2015).
For Asthma, follow GINA For COPD, follow GOLD.
COPD
patients with COPD in stable stage or acute exacerbation
no intervention
Intervention Type
OTHER
For Chronic Cough，follow《Guidelines for the diagnosis and treatment of cough》(2015).
For Asthma, follow GINA For COPD, follow GOLD.
Interventions
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no intervention
For Chronic Cough，follow《Guidelines for the diagnosis and treatment of cough》(2015).
For Asthma, follow GINA For COPD, follow GOLD.
Intervention Type
OTHER
Other Intervention Names
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guideline
Eligibility Criteria
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Inclusion Criteria
* Candidates voluntarily participate in and abide by the relevant regulations of the study, can cooperate with corresponding inspections, follow the follow-up plan, and voluntarily sign written informed consent.
* Patients with chronic cough
1. Coughing lasting ≥ 8 weeks,
2. There is no obvious abnormality in the chest X-ray
3. No clear history of upper respiratory tract infection in the past 4 weeks,
4. Newly diagnosed or untreated in the last 4 weeks
5. Non-smokers.
* Patients with Asthma
1. For newly diagnosed and previously diagnosed asthma patients, the diagnosis criteria for asthma:
2. Including various disease severity (mild, moderate, severe), various disease states (chronic duration, acute exacerbation period).
3. Non-smokers.
* Patients with COPD 1) Including patients in stable phase and acute exacerbation phase.
* Patients with chronic cough
1. Coughing lasting ≥ 8 weeks,
2. There is no obvious abnormality in the chest X-ray
3. No clear history of upper respiratory tract infection in the past 4 weeks,
4. Newly diagnosed or untreated in the last 4 weeks
5. Non-smokers.
* Patients with Asthma
1. For newly diagnosed and previously diagnosed asthma patients, the diagnosis criteria for asthma:
2. Including various disease severity (mild, moderate, severe), various disease states (chronic duration, acute exacerbation period).
3. Non-smokers.
* Patients with COPD 1) Including patients in stable phase and acute exacerbation phase.
Exclusion Criteria
* Diagnose patients with ACO;
* Those who cannot cooperate with the completion of research-related test, follow-ups and other reasons cannot cooperate with the progress of the research;
* Combined with serious diseases of other systems (such as cardiovascular, metabolic, immune, neurological, etc.). With other diseases of the lung, including bronchiectasis.
* Those who cannot cooperate with the completion of research-related test, follow-ups and other reasons cannot cooperate with the progress of the research;
* Combined with serious diseases of other systems (such as cardiovascular, metabolic, immune, neurological, etc.). With other diseases of the lung, including bronchiectasis.
Minimum Eligible Age
18 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Nanfang Hospital, Southern Medical University
OTHER
Sponsor Role
collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine
OTHER
Sponsor Role
collaborator
Huizhou Third People's Hospital
UNKNOWN
Sponsor Role
collaborator
Tongji Hospital
OTHER
Sponsor Role
collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Sponsor Role
collaborator
Ruijin Hospital
OTHER
Sponsor Role
collaborator
First Hospital of China Medical University
OTHER
Sponsor Role
collaborator
The First Affiliated Hospital of Shanxi Medical University
OTHER
Sponsor Role
collaborator
Henan Provincial People's Hospital
OTHER
Sponsor Role
collaborator
The Second Hospital of Hebei Medical University
OTHER
Sponsor Role
collaborator
West China Hospital
OTHER
Sponsor Role
collaborator
The First People's Hospital of Yunnan
OTHER
Sponsor Role
collaborator
Inner Mongolia People's Hospital
OTHER
Sponsor Role
collaborator
Second Hospital of Jilin University
OTHER
Sponsor Role
collaborator
The First Affiliated Hospital of Guangzhou Medical University
OTHER
Sponsor Role
lead
Responsible Party
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Kefang Lai
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Kefang Lai, phD
Role: STUDY_CHAIR
The First Affiliated Hospital of Guangzhou Medical University
Locations
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Guangzhou Institute of Respiratory health
Guangzhou, Guangdong, China
Site Status
Countries
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China
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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FeNO-Eos
Identifier Type: -
Identifier Source: org_study_id
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