The Value of FeNO in Predicting Airway Eosinophilic Inflammation

• Conditions: Biomarkers; Airway Inflammation
• Interventions: Other: no intervention

• Registration Number: NCT04885738
• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University

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.

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-09
• Study First Submitted QC: 2021-05-12
• Last Update Submitted: 2021-05-12
• Study First Posted: 2021-05-13
• Last Update Posted: 2021-05-13
• Study Start: 2021-05-25
• Primary Completion: 2022-03-25
• Study Completion: 2022-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2052

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.

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic Cough	no intervention	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.
Asthma	no intervention	classic asthma
COPD	no intervention	patients with COPD in stable stage or acute exacerbation

Primary Outcome Measures

Name	Time	Method
predictive value of FeNO in eosinophilic airway inflammation	12 months	predictive value of FeNO in eosinophilic airway inflammation in patients with chronic cough, classic asthma, COPD
predictive value of blood eosinophils in eosinophilic airway inflammation	12 months	predictive value of blood eosinophils in eosinophilic airway inflammation in patients with chronic cough, classic asthma, COPD
predictive value of TIgE in eosinophilic airway inflammation	12 months	predictive value of TIgE in eosinophilic airway inflammation in patients with chronic cough, classic asthma, COPD

Secondary Outcome Measures

Name	Time	Method
comparison of FeNO, blood eosinophils, TIgE in predicting eosinophilic airway inflammation	12 months	comparison the predictive value of FeNO, blood eosinophils, TIgE in eosinophilic airway inflammation in patients with chronic cough, classic asthma, COPD respectively
combination of biomarkers in predicting eosinophilic airway inflammation	12 months	combination of FeNO, blood eosinophils, TIgE in predicting eosinophilic airway inflammation in patients with chronic cough, classic asthma and COPD respectively

Trial Locations

Locations (1)

Guangzhou Institute of Respiratory health; 🇨🇳 Guangzhou, Guangdong, China