The Value of FeNO in Predicting Airway Eosinophilic Inflammation

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

Sponsors

Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University

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

Source 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.

Overall Status Not yet recruiting
Start Date 2021-05-25
Completion Date 2022-05-30
Primary Completion Date 2022-03-25
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
predictive value of FeNO in eosinophilic airway inflammation 12 months
predictive value of blood eosinophils in eosinophilic airway inflammation 12 months
predictive value of TIgE in eosinophilic airway inflammation 12 months
Secondary Outcome
Measure Time Frame
comparison of FeNO, blood eosinophils, TIgE in predicting eosinophilic airway inflammation 12 months
combination of biomarkers in predicting eosinophilic airway inflammation 12 months
Enrollment 2052
Condition
Intervention

Intervention Type: Other

Intervention Name: no intervention

Description: For Chronic Cough,follow《Guidelines for the diagnosis and treatment of cough》(2015). For Asthma, follow GINA For COPD, follow GOLD.

Other Name: guideline

Eligibility

Sampling Method:

Probability Sample

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 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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

70 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Kefang Lai, phD Study Chair The First Affiliated Hospital of Guangzhou Medical University
Overall Contact

Last Name: Kefang Lai, phD

Phone: 0086+020-8306-2891

Email: [email protected]

Location
Facility: Contact: Investigator: Guangzhou Institute of Respiratory health Kefang Lai, PhD 8620-83062893 [email protected] Kefang Lai, phD Principal Investigator
Location Countries

China

Verification Date

2021-05-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: The First Affiliated Hospital of Guangzhou Medical University

Investigator Full Name: Kefang Lai

Investigator Title: Professor

Has Expanded Access No
Condition Browse
Arm Group

Label: Chronic Cough

Description: 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.

Label: Asthma

Description: classic asthma

Label: COPD

Description: patients with COPD in stable stage or acute exacerbation

Acronym FeNO-Eos
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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