BiomarkersFeNO-EosNCT04885738
The Value of FeNO in Predicting Airway Eosinophilic Inflammation
An observational study of Biomarkers and Airway Inflammation, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Biomarkers, Airway Inflammation
- How many people
- 2,052 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2021to 30 May 2022
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic cough, asthma, and COPD patients
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Institute of Respiratory health
Guangzhou, Guangdong, 510120
Kefang Lai, PhD, 8620-83062893, klai@163.com
Kefang Lai, phD
About this study
Official title: 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.
Read the 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.
- Conditions
- Biomarkers, Airway Inflammation
- Being tested
- no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
Also called guideline
For Chronic Cough，follow《Guidelines for the diagnosis and treatment of cough》(2015).
For Asthma, follow GINA For COPD, follow GOLD.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: no intervention | |
| Asthma | classic asthma Receives: Other: no intervention | |
| COPD | patients with COPD in stable stage or acute exacerbation Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
predictive value of FeNO in eosinophilic airway inflammation
predictive value of FeNO in eosinophilic airway inflammation in patients with chronic cough, classic asthma, COPD
Measured: 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
Measured: 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
Measured: 12 months
Secondary outcomes (2)
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
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start25 May 2021 (estimated)
- Primary completion25 Mar 2022 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for BiomarkersStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,052 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, Guangdong Provincial Hospital of Traditional Chinese Medicine, The Third People's Hospital of Huizhou, 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
- Responsible party
- Principal investigator, Kefang Lai, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Kefang Lai, phD, Study chair, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885738
- Sponsor's protocol ID
- FeNO-Eos
- Acronym
- FeNO-Eos
- Status last verified
- May 2021
- First submitted
- 9 May 2021
- Last updated
- 13 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yi F, Chen R, Luo W, Xu D, Han L, Liu B, Jiang S, Chen Q, Lai K. Validity of Fractional Exhaled Nitric Oxide in Diagnosis of Corticosteroid-Responsive Cough. Chest. 2016 Apr;149(4):1042-51. doi: 10.1016/j.chest.2016.01.006. Epub 2016 Jan 22.
PubMed 26836931Lai K, Chen R, Lin J, Huang K, Shen H, Kong L, Zhou X, Luo Z, Yang L, Wen F, Zhong N. A prospective, multicenter survey on causes of chronic cough in China. Chest. 2013 Mar;143(3):613-620. doi: 10.1378/chest.12-0441.
PubMed 23238526Lane C, Knight D, Burgess S, Franklin P, Horak F, Legg J, Moeller A, Stick S. Epithelial inducible nitric oxide synthase activity is the major determinant of nitric oxide concentration in exhaled breath. Thorax. 2004 Sep;59(9):757-60. doi: 10.1136/thx.2003.014894.
PubMed 15333851Alving K, Malinovschi A. Basic aspects of exhaled nitric oxide. European Respiratory Monograph. 2010;49:1-31.
Oh MJ, Lee JY, Lee BJ, Choi DC. Exhaled nitric oxide measurement is useful for the exclusion of nonasthmatic eosinophilic bronchitis in patients with chronic cough. Chest. 2008 Nov;134(5):990-995. doi: 10.1378/chest.07-2541. Epub 2008 Jun 26.
PubMed 18583518Sato S, Saito J, Sato Y, Ishii T, Xintao W, Tanino Y, Ishida T, Munakata M. Clinical usefulness of fractional exhaled nitric oxide for diagnosing prolonged cough. Respir Med. 2008 Oct;102(10):1452-9. doi: 10.1016/j.rmed.2008.04.018. Epub 2008 Jul 9.
PubMed 18614345Prieto L, Ferrer A, Ponce S, Palop J, Marin J. Exhaled nitric oxide measurement is not useful for predicting the response to inhaled corticosteroids in subjects with chronic cough. Chest. 2009 Sep;136(3):816-822. doi: 10.1378/chest.08-2942. Epub 2009 May 1.
PubMed 19411296Smith AD, Cowan JO, Filsell S, McLachlan C, Monti-Sheehan G, Jackson P, Taylor DR. Diagnosing asthma: comparisons between exhaled nitric oxide measurements and conventional tests. Am J Respir Crit Care Med. 2004 Feb 15;169(4):473-8. doi: 10.1164/rccm.200310-1376OC. Epub 2003 Nov 25.
PubMed 14644933Berry MA, Shaw DE, Green RH, Brightling CE, Wardlaw AJ, Pavord ID. The use of exhaled nitric oxide concentration to identify eosinophilic airway inflammation: an observational study in adults with asthma. Clin Exp Allergy. 2005 Sep;35(9):1175-9. doi: 10.1111/j.1365-2222.2005.02314.x.
PubMed 16164444Silkoff PE, Lent AM, Busacker AA, Katial RK, Balzar S, Strand M, Wenzel SE. Exhaled nitric oxide identifies the persistent eosinophilic phenotype in severe refractory asthma. J Allergy Clin Immunol. 2005 Dec;116(6):1249-55. doi: 10.1016/j.jaci.2005.09.029. Epub 2005 Nov 8.
PubMed 16337453Fukuhara A, Saito J, Sato S, Sato Y, Nikaido T, Saito K, Fukuhara-Nakagawa N, Inokoshi Y, Ishii T, Tanino Y, Ishida T, Munakata M. Validation study of asthma screening criteria based on subjective symptoms and fractional exhaled nitric oxide. Ann Allergy Asthma Immunol. 2011 Dec;107(6):480-6. doi: 10.1016/j.anai.2011.09.002. Epub 2011 Oct 1.
PubMed 22123376Korevaar DA, Westerhof GA, Wang J, Cohen JF, Spijker R, Sterk PJ, Bel EH, Bossuyt PM. Diagnostic accuracy of minimally invasive markers for detection of airway eosinophilia in asthma: a systematic review and meta-analysis. Lancet Respir Med. 2015 Apr;3(4):290-300. doi: 10.1016/S2213-2600(15)00050-8. Epub 2015 Mar 20.
PubMed 25801413Donohue JF, Jain N. Exhaled nitric oxide to predict corticosteroid responsiveness and reduce asthma exacerbation rates. Respir Med. 2013 Jul;107(7):943-52. doi: 10.1016/j.rmed.2013.02.018. Epub 2013 Apr 17.
PubMed 23601567Schneider A, Schwarzbach J, Faderl B, Welker L, Karsch-Volk M, Jorres RA. FENO measurement and sputum analysis for diagnosing asthma in clinical practice. Respir Med. 2013 Feb;107(2):209-16. doi: 10.1016/j.rmed.2012.10.003. Epub 2012 Oct 27.
PubMed 23107283Jatakanon A, Lim S, Kharitonov SA, Chung KF, Barnes PJ. Correlation between exhaled nitric oxide, sputum eosinophils, and methacholine responsiveness in patients with mild asthma. Thorax. 1998 Feb;53(2):91-5. doi: 10.1136/thx.53.2.91.
PubMed 9624291
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Exhaled Nitric Oxide in Predicting Airway Eosinophilic Inflammation in Chronic Airway Inflammatory Disease
- ClinicalTrials.gov ID
- NCT04885738
- Acronym / sponsor ID
- FeNO-Eos / FeNO-Eos
- Conditions
- Biomarkers, Airway Inflammation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,052 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, Guangdong Provincial Hospital of Traditional Chinese Medicine, The Third People's Hospital of Huizhou, 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
- Study start
- 25 May 2021 (estimated)
- Primary completion
- 25 Mar 2022 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chronic Cough | – | Other: no interventioncough 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 | – | Other: no interventionclassic asthma |
| COPD | – | Other: no interventionpatients with COPD in stable stage or acute exacerbation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic cough, asthma, and COPD patients
Key inclusion criteria (12 listed)
- 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
- Patients with Asthma
- Patients with COPD 1) Including patients in stable phase and acute exacerbation phase.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionAlso: guidelineFor Chronic Cough，follow《Guidelines for the diagnosis and treatment of cough》(2015). For Asthma, follow GINA For COPD, follow GOLD. | Other | Asthma, COPD, Chronic Cough |
Primary outcome
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
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
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
2 secondary outcomes
comparison of FeNO, blood eosinophils, TIgE in predicting eosinophilic airway inflammation
Time frame: 12 months
combination of biomarkers in predicting eosinophilic airway inflammation
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Background: PubMed 26836931Yi F, Chen R, Luo W, Xu D, Han L, Liu B, Jiang S, Chen Q, Lai K. Validity of Fractional Exhaled Nitric Oxide in Diagnosis of Corticosteroid-Responsive Cough. Chest. 2016 Apr;149(4):1042-51. doi: 10.1016/j.chest.2016.01.006. Epub 2016 Jan 22.
- Background: PubMed 23238526Lai K, Chen R, Lin J, Huang K, Shen H, Kong L, Zhou X, Luo Z, Yang L, Wen F, Zhong N. A prospective, multicenter survey on causes of chronic cough in China. Chest. 2013 Mar;143(3):613-620. doi: 10.1378/chest.12-0441.
- Background: PubMed 15333851Lane C, Knight D, Burgess S, Franklin P, Horak F, Legg J, Moeller A, Stick S. Epithelial inducible nitric oxide synthase activity is the major determinant of nitric oxide concentration in exhaled breath. Thorax. 2004 Sep;59(9):757-60. doi: 10.1136/thx.2003.014894.
- BackgroundAlving K, Malinovschi A. Basic aspects of exhaled nitric oxide. European Respiratory Monograph. 2010;49:1-31.
- Background: PubMed 18583518Oh MJ, Lee JY, Lee BJ, Choi DC. Exhaled nitric oxide measurement is useful for the exclusion of nonasthmatic eosinophilic bronchitis in patients with chronic cough. Chest. 2008 Nov;134(5):990-995. doi: 10.1378/chest.07-2541. Epub 2008 Jun 26.
- Background: PubMed 18614345Sato S, Saito J, Sato Y, Ishii T, Xintao W, Tanino Y, Ishida T, Munakata M. Clinical usefulness of fractional exhaled nitric oxide for diagnosing prolonged cough. Respir Med. 2008 Oct;102(10):1452-9. doi: 10.1016/j.rmed.2008.04.018. Epub 2008 Jul 9.
- Background: PubMed 19411296Prieto L, Ferrer A, Ponce S, Palop J, Marin J. Exhaled nitric oxide measurement is not useful for predicting the response to inhaled corticosteroids in subjects with chronic cough. Chest. 2009 Sep;136(3):816-822. doi: 10.1378/chest.08-2942. Epub 2009 May 1.
- Background: PubMed 14644933Smith AD, Cowan JO, Filsell S, McLachlan C, Monti-Sheehan G, Jackson P, Taylor DR. Diagnosing asthma: comparisons between exhaled nitric oxide measurements and conventional tests. Am J Respir Crit Care Med. 2004 Feb 15;169(4):473-8. doi: 10.1164/rccm.200310-1376OC. Epub 2003 Nov 25.
- Background: PubMed 16164444Berry MA, Shaw DE, Green RH, Brightling CE, Wardlaw AJ, Pavord ID. The use of exhaled nitric oxide concentration to identify eosinophilic airway inflammation: an observational study in adults with asthma. Clin Exp Allergy. 2005 Sep;35(9):1175-9. doi: 10.1111/j.1365-2222.2005.02314.x.
- Background: PubMed 16337453Silkoff PE, Lent AM, Busacker AA, Katial RK, Balzar S, Strand M, Wenzel SE. Exhaled nitric oxide identifies the persistent eosinophilic phenotype in severe refractory asthma. J Allergy Clin Immunol. 2005 Dec;116(6):1249-55. doi: 10.1016/j.jaci.2005.09.029. Epub 2005 Nov 8.
- Background: PubMed 22123376Fukuhara A, Saito J, Sato S, Sato Y, Nikaido T, Saito K, Fukuhara-Nakagawa N, Inokoshi Y, Ishii T, Tanino Y, Ishida T, Munakata M. Validation study of asthma screening criteria based on subjective symptoms and fractional exhaled nitric oxide. Ann Allergy Asthma Immunol. 2011 Dec;107(6):480-6. doi: 10.1016/j.anai.2011.09.002. Epub 2011 Oct 1.
- Background: PubMed 25801413Korevaar DA, Westerhof GA, Wang J, Cohen JF, Spijker R, Sterk PJ, Bel EH, Bossuyt PM. Diagnostic accuracy of minimally invasive markers for detection of airway eosinophilia in asthma: a systematic review and meta-analysis. Lancet Respir Med. 2015 Apr;3(4):290-300. doi: 10.1016/S2213-2600(15)00050-8. Epub 2015 Mar 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kefang Lai, phD study chair
The First Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biomarkers and Airway Inflammation, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kefang Lai, phD (0086+020-8306-2891, klai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
predictive value of FeNO in eosinophilic airway inflammation (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04885738, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2021.