The Value of FeNO in Predicting Airway Eosinophilic Inflammation

Biomarkers Clinical Trial

— FeNO-Eos  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04885738
• Other study ID #: FeNO-Eos
• Status: Not yet recruiting
• Start date: May 25, 2021
• Est. completion date: May 30, 2022

Study information

• Verified date: May 2021
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: Kefang Lai, phD
• Phone: 0086+020-8306-2891
• Email: klai[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To investigate and compare the value of FeNO, blood Eos, serum TIgE in predicting the airway eosinophilic inflammationin chronic cough, asthma and COPD.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2052
• Est. completion date: May 30, 2022
• Est. primary completion date: March 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Airway Inflammation
• Biomarkers
• Inflammation

Intervention

Other:
• no intervention
For Chronic Cough,follow«Guidelines for the diagnosis and treatment of cough»(2015). For Asthma, follow GINA For COPD, follow GOLD.

Locations

Country	Name	City	State
China	Guangzhou Institute of Respiratory health	Guangzhou	Guangdong

Sponsors (15)

Lead Sponsor

Collaborator

The First Affiliated Hospital of Guangzhou Medical University

First Hospital of China Medical University, Guangdong Provincial Hospital of Traditional Chinese Medicine, Henan Provincial People's Hospital, Huizhou The Third People's Hospital, Inner Mongolia People's Hospital, Nanfang Hospital of Southern Medical University, Ruijin Hospital, Second Hospital of Jilin University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, The First Affiliated Hospital of Shanxi Medical University, The First People's Hospital of Yunnan, The Second Hospital of Hebei Medical University, Tongji Hospital, West China Hospital

Country where clinical trial is conducted

China, 

References & Publications (36)

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* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	correlation	correlation between FeNO and sputum eosinophils before and after the treatment in patients with chronic cough, asthma	12 months
Primary	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
Primary	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
Primary	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	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
Secondary	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