The Value of FeNO in Predicting Airway Eosinophilic Inflammation (FeNO-Eos)

May 12, 2021 updated by: Kefang Lai, The First Affiliated Hospital of Guangzhou Medical University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

2052

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kefang Lai, phD
  • Phone Number: 0086+020-8306-2891
  • Email: klai@163.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Guangzhou Institute of Respiratory Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Chronic cough, asthma, and COPD patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: no intervention

For Chronic Cough，follow《Guidelines for the diagnosis and treatment of cough》(2015).

For Asthma, follow GINA For COPD, follow GOLD.

Other Names:
  • guideline
Asthma
classic asthma
Other: no intervention

For Chronic Cough，follow《Guidelines for the diagnosis and treatment of cough》(2015).

For Asthma, follow GINA For COPD, follow GOLD.

Other Names:
  • guideline
COPD
patients with COPD in stable stage or acute exacerbation
Other: no intervention

For Chronic Cough，follow《Guidelines for the diagnosis and treatment of cough》(2015).

For Asthma, follow GINA For COPD, follow GOLD.

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
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
combination of FeNO, blood eosinophils, TIgE in predicting eosinophilic airway inflammation in patients with chronic cough, classic asthma and COPD respectively
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation
Time Frame: 12 months
correlation between FeNO and sputum eosinophils before and after the treatment in patients with chronic cough, asthma
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Collaborators

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

Investigators

  • Study Chair: Kefang Lai, phD, The First Affiliated Hospital of Guangzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 25, 2021

Primary Completion (ANTICIPATED)

March 25, 2022

Study Completion (ANTICIPATED)

May 30, 2022

Study Registration Dates

First Submitted

May 9, 2021

First Submitted That Met QC Criteria

May 12, 2021

First Posted (ACTUAL)

May 13, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 13, 2021

Last Update Submitted That Met QC Criteria

May 12, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FeNO-Eos

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Biomarkers

Clinical Trials on no intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe