The Value of FeNO in Predicting Airway Eosinophilic Inflammation

NCT04885738 | Unknown

• 1 other identifier: FeNO-Eos
• Study Type: observational
• Target: 2,052
• Locations: 1 country
• Sites: 1

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.

Conditions

Biomarkers; Airway Inflammation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• comparison of FeNO, blood eosinophils, TIgE in predicting eosinophilic airway inflammation

  12 months

• combination of biomarkers in predicting eosinophilic airway inflammation

  12 months

Other Outcomes (1)

• correlation

  12 months

Study Arms (3)

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

Asthma

classic asthma

Other: no intervention

COPD

patients with COPD in stable stage or acute exacerbation

Other: no intervention

Interventions

no intervention OTHER

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

Also known as: guideline

Asthma; COPD; Chronic Cough

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chronic cough, asthma, and COPD patients

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Guangzhou Institute of Respiratory health

Guangzhou, Guangdong, 510120, China

Location

Related Publications (36)

• 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.

  PMID: 26836931 BACKGROUND

• Lai 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.

  PMID: 23238526 BACKGROUND

• Lane 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.

  PMID: 15333851 BACKGROUND

• Alving K, Malinovschi A. Basic aspects of exhaled nitric oxide. European Respiratory Monograph. 2010;49:1-31.

  BACKGROUND

• 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.

  PMID: 18583518 BACKGROUND

• Sato 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.

  PMID: 18614345 BACKGROUND

• Prieto 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.

  PMID: 19411296 BACKGROUND

• Smith 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.

  PMID: 14644933 BACKGROUND

• Berry 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.

  PMID: 16164444 BACKGROUND

• Silkoff 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.

  PMID: 16337453 BACKGROUND

• Fukuhara 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.

  PMID: 22123376 BACKGROUND

• Korevaar 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.

  PMID: 25801413 BACKGROUND

• Donohue 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.

  PMID: 23601567 BACKGROUND

• Schneider 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.

  PMID: 23107283 BACKGROUND

• Jatakanon 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.

  PMID: 9624291 BACKGROUND

• Jones SL, Kittelson J, Cowan JO, Flannery EM, Hancox RJ, McLachlan CR, Taylor DR. The predictive value of exhaled nitric oxide measurements in assessing changes in asthma control. Am J Respir Crit Care Med. 2001 Sep 1;164(5):738-43. doi: 10.1164/ajrccm.164.5.2012125.

  PMID: 11549525 BACKGROUND

• Schleich FN, Seidel L, Sele J, Manise M, Quaedvlieg V, Michils A, Louis R. Exhaled nitric oxide thresholds associated with a sputum eosinophil count >/=3% in a cohort of unselected patients with asthma. Thorax. 2010 Dec;65(12):1039-44. doi: 10.1136/thx.2009.124925. Epub 2010 Jul 29.

  PMID: 20671307 BACKGROUND

• Zhang YM, Lin JT. [The values of fractional exhaled nitric oxide in the diagnosis and treatment of chronic cough]. Zhonghua Jie He He Hu Xi Za Zhi. 2011 Jul;34(7):504-8. Chinese.

  PMID: 22041775 BACKGROUND

• Lemiere C, Ernst P, Olivenstein R, Yamauchi Y, Govindaraju K, Ludwig MS, Martin JG, Hamid Q. Airway inflammation assessed by invasive and noninvasive means in severe asthma: eosinophilic and noneosinophilic phenotypes. J Allergy Clin Immunol. 2006 Nov;118(5):1033-9. doi: 10.1016/j.jaci.2006.08.003. Epub 2006 Sep 25.

  PMID: 17088126 BACKGROUND

• Dweik RA, Boggs PB, Erzurum SC, Irvin CG, Leigh MW, Lundberg JO, Olin AC, Plummer AL, Taylor DR; American Thoracic Society Committee on Interpretation of Exhaled Nitric Oxide Levels (FENO) for Clinical Applications. An official ATS clinical practice guideline: interpretation of exhaled nitric oxide levels (FENO) for clinical applications. Am J Respir Crit Care Med. 2011 Sep 1;184(5):602-15. doi: 10.1164/rccm.9120-11ST.

  PMID: 21885636 BACKGROUND

• ten Brinke A, Zwinderman AH, Sterk PJ, Rabe KF, Bel EH. Factors associated with persistent airflow limitation in severe asthma. Am J Respir Crit Care Med. 2001 Sep 1;164(5):744-8. doi: 10.1164/ajrccm.164.5.2011026.

  PMID: 11549526 BACKGROUND

• Meijer RJ, Postma DS, Kauffman HF, Arends LR, Koeter GH, Kerstjens HA. Accuracy of eosinophils and eosinophil cationic protein to predict steroid improvement in asthma. Clin Exp Allergy. 2002 Jul;32(7):1096-103. doi: 10.1046/j.1365-2222.2002.01412.x.

  PMID: 12100060 BACKGROUND

• Hastie AT, Moore WC, Li H, Rector BM, Ortega VE, Pascual RM, Peters SP, Meyers DA, Bleecker ER; National Heart, Lung, and Blood Institute's Severe Asthma Research Program. Biomarker surrogates do not accurately predict sputum eosinophil and neutrophil percentages in asthmatic subjects. J Allergy Clin Immunol. 2013 Jul;132(1):72-80. doi: 10.1016/j.jaci.2013.03.044. Epub 2013 May 21.

  PMID: 23706399 BACKGROUND

• Westerhof GA, Korevaar DA, Amelink M, de Nijs SB, de Groot JC, Wang J, Weersink EJ, ten Brinke A, Bossuyt PM, Bel EH. Biomarkers to identify sputum eosinophilia in different adult asthma phenotypes. Eur Respir J. 2015 Sep;46(3):688-96. doi: 10.1183/09031936.00012415. Epub 2015 Jun 25.

  PMID: 26113672 BACKGROUND

• Pacheco A, Faro V, Cobeta I, Royuela A, Molyneux I, Morice AH. Gastro-oesophageal reflux, eosinophilic airway inflammation and chronic cough. Respirology. 2011 Aug;16(6):994-9. doi: 10.1111/j.1440-1843.2011.02010.x.

  PMID: 21651646 BACKGROUND

• Saha S, Brightling CE. Eosinophilic airway inflammation in COPD. Int J Chron Obstruct Pulmon Dis. 2006;1(1):39-47. doi: 10.2147/copd.2006.1.1.39.

  PMID: 18046901 BACKGROUND

• Zietkowski Z, Kucharewicz I, Bodzenta-Lukaszyk A. The influence of inhaled corticosteroids on exhaled nitric oxide in stable chronic obstructive pulmonary disease. Respir Med. 2005 Jul;99(7):816-24. doi: 10.1016/j.rmed.2004.12.008.

  PMID: 15939243 BACKGROUND

• Antus B, Barta I, Horvath I, Csiszer E. Relationship between exhaled nitric oxide and treatment response in COPD patients with exacerbations. Respirology. 2010 Apr;15(3):472-7. doi: 10.1111/j.1440-1843.2010.01711.x. Epub 2010 Feb 24.

  PMID: 20210889 BACKGROUND

• Franklin PJ, Stick SM, Le Souef PN, Ayres JG, Turner SW. Measuring exhaled nitric oxide levels in adults: the importance of atopy and airway responsiveness. Chest. 2004 Nov;126(5):1540-5. doi: 10.1378/chest.126.5.1540.

  PMID: 15539724 BACKGROUND

• Olin AC, Rosengren A, Thelle DS, Lissner L, Bake B, Toren K. Height, age, and atopy are associated with fraction of exhaled nitric oxide in a large adult general population sample. Chest. 2006 Nov;130(5):1319-25. doi: 10.1378/chest.130.5.1319.

  PMID: 17099006 BACKGROUND

• Gelb AF, George SC, Camacho F, Fraser C, Flynn Taylor C, Shakkottai S. Increased nitric oxide concentrations in the small airway of older normal subjects. Chest. 2011 Feb;139(2):368-375. doi: 10.1378/chest.10-1157. Epub 2010 Aug 12.

  PMID: 20705799 BACKGROUND

• Zetterquist W, Pedroletti C, Lundberg JO, Alving K. Salivary contribution to exhaled nitric oxide. Eur Respir J. 1999 Feb;13(2):327-33. doi: 10.1034/j.1399-3003.1999.13b18.x.

  PMID: 10065676 BACKGROUND

• Deykin A, Halpern O, Massaro AF, Drazen JM, Israel E. Expired nitric oxide after bronchoprovocation and repeated spirometry in patients with asthma. Am J Respir Crit Care Med. 1998 Mar;157(3 Pt 1):769-75. doi: 10.1164/ajrccm.157.3.9707114.

  PMID: 9517589 BACKGROUND

• Sanders SP, Proud D, Permutt S, Siekierski ES, Yachechko R, Liu MC. Role of nasal nitric oxide in the resolution of experimental rhinovirus infection. J Allergy Clin Immunol. 2004 Apr;113(4):697-702. doi: 10.1016/j.jaci.2004.01.755.

  PMID: 15100676 BACKGROUND

• Petsky HL, Kynaston JA, McElrea M, Turner C, Isles A, Chang AB. Cough and exhaled nitric oxide levels: what happens with exercise? Front Pediatr. 2013 Oct 24;1:30. doi: 10.3389/fped.2013.00030. eCollection 2013.

  PMID: 24400276 BACKGROUND

• Silkoff PE, McClean PA, Slutsky AS, Caramori M, Chapman KR, Gutierrez C, Zamel N. Exhaled nitric oxide and bronchial reactivity during and after inhaled beclomethasone in mild asthma. J Asthma. 1998;35(6):473-9. doi: 10.3109/02770909809071000.

  PMID: 9751064 BACKGROUND

MeSH Terms

Interventions

Guidelines as Topic

Intervention Hierarchy (Ancestors)

Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Kefang Lai, phD

  The First Affiliated Hospital of Guangzhou Medical University

  STUDY CHAIR

Central Study Contacts

Kefang Lai, phD

CONTACT

0086+020-8306-2891; klai@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 9, 2021
• First Posted: May 13, 2021
• Study Start: May 25, 2021
• Primary Completion: March 25, 2022
• Study Completion: May 30, 2022
• Last Updated: May 13, 2021

Record last verified: 2021-05

Locations

CN (1)