The Value of FeNO in Predicting Airway Eosinophilic Inflammation

Study Overview
=================
Brief Summary
-----------------
To investigate and compare the value of FeNO, blood Eos, serum TIgE in predicting the airway eosinophilic inflammationin chronic cough, asthma and COPD.

Detailed Description
-----------------
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.

Official Title
-----------------
The Value of Exhaled Nitric Oxide in Predicting Airway Eosinophilic Inflammation in Chronic Airway Inflammatory Disease

Conditions
-----------------
Biomarkers, Airway Inflammation

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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 Coughing lasting ≥ 8 weeks, There is no obvious abnormality in the chest X-ray No clear history of upper respiratory tract infection in the past 4 weeks, Newly diagnosed or untreated in the last 4 weeks Non-smokers. Patients with Asthma For newly diagnosed and previously diagnosed asthma patients, the diagnosis criteria for asthma: Including various disease severity (mild, moderate, severe), various disease states (chronic duration, acute exacerbation period). 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic Cough<br>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. | Other: no intervention<br>* For Chronic Cough，follow《Guidelines for the diagnosis and treatment of cough》(2015). For Asthma, follow GINA For COPD, follow GOLD.<br>* Other names: guideline;|
| Asthma<br>classic asthma | Other: no intervention<br>* For Chronic Cough，follow《Guidelines for the diagnosis and treatment of cough》(2015). For Asthma, follow GINA For COPD, follow GOLD.<br>* Other names: guideline;|
| COPD<br>patients with COPD in stable stage or acute exacerbation | Other: no intervention<br>* For Chronic Cough，follow《Guidelines for the diagnosis and treatment of cough》(2015). For Asthma, follow GINA For COPD, follow GOLD.<br>* Other names: guideline;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| predictive value of FeNO in eosinophilic airway inflammation | predictive value of FeNO in eosinophilic airway inflammation in patients with chronic cough, classic asthma, COPD | 12 months | 
| predictive value of blood eosinophils in eosinophilic airway inflammation | predictive value of blood eosinophils in eosinophilic airway inflammation in patients with chronic cough, classic asthma, COPD | 12 months | 
| predictive value of TIgE in eosinophilic airway inflammation | predictive value of TIgE in eosinophilic airway inflammation in patients with chronic cough, classic asthma, COPD | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of FeNO, blood eosinophils, TIgE in predicting eosinophilic airway inflammation | comparison the predictive value of FeNO, blood eosinophils, TIgE in eosinophilic airway inflammation in patients with chronic cough, classic asthma, COPD respectively | 12 months | 
| combination of biomarkers in predicting eosinophilic airway inflammation | combination of FeNO, blood eosinophils, TIgE in predicting eosinophilic airway inflammation in patients with chronic cough, classic asthma and COPD respectively | 12 months |