Detection and Use of Nasal Nitrous Oxide and the Electronic Nose

NCT02476929 | Completed

• 1 other identifier: IIBSP-ONA-2011-146
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Rhinitis, sinonasal polyposis (SP) and asthma are diseases whose pathogenesis is based on inflammation. This will determine the presence of disease, its evolution and its treatment. It is therefore very important to develop and validate methodologies that allow us to noninvasively detect inflammation of the airways. Thus, just as exhaled nitric oxide (FeNO) has been studied as an important non-invasive marker of inflammation of the lower airways, nasal nitric oxide (nNO) may be a good marker of nasal inflammation. Furthermore, the electronic nose is an electronic nanosensor device capable of detecting specific volatile organic compounds (VOCs) that can be used as a non-invasive biomarker of biochemical processes in different diseases whose pathophysiology is also based on inflammation. Objective: To determine reference values of nNO and different patterns of VOCs in healthy individuals, individuals with allergic rhinitis (AR) and non-allergic rhinitis and individuals with SP and asthma. Methodology: Prospective, controlled study. Four groups will be included: Healthy subjects, patients with AR, non-allergic rhinitis and patients with SP and asthma (n=252). Prick-test to pneumoallergens will be performed. Determination of FeNO, nNO, lung function tests, measurement of VOCs by the electronic nose and blood samples will be taken. Bilateral nasal endoscopy and sample collection using the technique of brushing of mucosa and the placement of filter papers, for the study of nasal cytology and mediators of inflammation.

Conditions

Allergic Rhinitis; Non-Allergic Rhinitis; Nasal Polyps

Keywords

Electronic nose; Nasal nitrous oxide; Allergic Rhinitis; Non-Allergic Rhinitis; Nasal polyps

Outcome Measures

Primary Outcomes (2)

• Values of nNO measure as parts per billions (ppb)

  12 months

• Values of the electronic nose measure as volatile organic compounts (VOCs)

  12 months

Study Arms (2)

Nasal nitrous oxide

ACTIVE COMPARATOR

Mesurement of Nasal nitrous oxide in all groups: allergic rhinitis, non-allergic rhinitis, nasosinusal polyps and healthy group

Device: Nasal nitrous oxide

Electronic nose

ACTIVE COMPARATOR

Measurement with the Electronic nose in all groups: allergic rhinitis, non-allergic rhinitis, nasosinusal polyps and healthy group.

Device: Electronic nose

Interventions

Nasal nitrous oxide DEVICE

Electrochemical device (NOVario Analizer FILT), to determine reference values of Nasal nitrous oxide.

Nasal nitrous oxide

Electronic nose DEVICE

To determine reference values of different patterns of specific volatile organic compounds with the electronic nose (Cyranose 320®).

Electronic nose

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sample of healthy individuals: Non-atopic individuals will be considered when skin prick skin tests with a standard battery of pneumoallergens are negative.
• Individuals with nasal endoscopy not showing inflammatory lesions or anatomic abnormalities and who have an acoustic rhinometry compatible with normal values.
• No sign of any acute infectious process during the four weeks preceding the study.
• Signed informed consent.
• Sample of individuals with Allergic Rhinitis: Atopic patients sensitized by skin prick testing and specific IgE determination to at least one perennial allergen.
• Patients with symptoms compatible with persistent moderate or severe AR as rated by the ARIA 2008 guide of at least two years of evolution.
• No acute infectious process during the four weeks preceding the study.
• Signed informed consent.
• Sample of individuals with non-allergic rhinitis: The subject will be considered non-atopic when skin prick skin tests with a standard battery of pneumoallergens are negative.
• Patients with symptoms of sneezing, watery rhinorrhea, nasal itching and/or nasal obstruction of at least two years evolution.
• No acute infectious process during the four weeks preceding the study.
• Signed informed consent.
• Sample of individuals diagnosed with Sinunasal Polyposis and asthma: Patients diagnosed with asthma by clinical and lung function tests.
• SP patients diagnosed by performing nasal endoscopy and CT of the paranasal sinuses.
• Could be non-atopic patients or present any concomitant allergic diseases.

You may not qualify if:

• Smoker with history of more than 10 pack-years.
• Pregnancy.
• Having been treated with nasal or systemic drugs that may alter nasal resistance (vasoconstrictors, anticholinergics, corticosteroids, antihistamines, immunosuppressants and/or immunomodulators) during the past three weeks.
• History of nasal surgery.
• Having an autoimmune or inflammatory systemic disease.
• Having an established diagnosis of intrinsic or extrinsic asthma (except polyposis group).
• Individuals with pathological nasal endoscopy.
• Suffering from a neoplastic disease.
• Having been treated with nasal or systemic drugs that may alter nasal resistance (vasoconstrictors, anticholinergics, corticosteroids, antihistamines, immunosuppressants and/or immunomodulators) during the past three weeks.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Universitat Autonoma de Barcelona: collaborator
• Sociedad Española de Alergología e Inmunología Clínica: collaborator
• Sociedad Española de Neumología y Cirugía Torácica: collaborator

Study Sites (1)

Lorena Soto-Retes

Barcelona, 08025, Spain

Location

Related Publications (12)

• Dragonieri S, Schot R, Mertens BJ, Le Cessie S, Gauw SA, Spanevello A, Resta O, Willard NP, Vink TJ, Rabe KF, Bel EH, Sterk PJ. An electronic nose in the discrimination of patients with asthma and controls. J Allergy Clin Immunol. 2007 Oct;120(4):856-62. doi: 10.1016/j.jaci.2007.05.043. Epub 2007 Jul 20.

  PMID: 17658592 BACKGROUND

• Silkoff PE, Robbins RA, Gaston B, Lundberg JO, Townley RG. Endogenous nitric oxide in allergic airway disease. J Allergy Clin Immunol. 2000 Mar;105(3):438-48. doi: 10.1067/mai.2000.104938.

  PMID: 10719291 RESULT

• Lundberg JO, Farkas-Szallasi T, Weitzberg E, Rinder J, Lidholm J, Anggaard A, Hokfelt T, Lundberg JM, Alving K. High nitric oxide production in human paranasal sinuses. Nat Med. 1995 Apr;1(4):370-3. doi: 10.1038/nm0495-370.

  PMID: 7585069 RESULT

• Dotsch J, Demirakca S, Terbrack HG, Huls G, Rascher W, Kuhl PG. Airway nitric oxide in asthmatic children and patients with cystic fibrosis. Eur Respir J. 1996 Dec;9(12):2537-40. doi: 10.1183/09031936.96.09122537.

  PMID: 8980966 RESULT

• Ferguson EA, Eccles R. Changes in nasal nitric oxide concentration associated with symptoms of common cold and treatment with a topical nasal decongestant. Acta Otolaryngol. 1997 Jul;117(4):614-7. doi: 10.3109/00016489709113447.

  PMID: 9288222 RESULT

• Kharitonov SA, Rajakulasingam K, O'Connor B, Durham SR, Barnes PJ. Nasal nitric oxide is increased in patients with asthma and allergic rhinitis and may be modulated by nasal glucocorticoids. J Allergy Clin Immunol. 1997 Jan;99(1 Pt 1):58-64. doi: 10.1016/s0091-6749(97)70301-4.

  PMID: 9003212 RESULT

• Arnal JF, Didier A, Rami J, M'Rini C, Charlet JP, Serrano E, Besombes JP. Nasal nitric oxide is increased in allergic rhinitis. Clin Exp Allergy. 1997 Apr;27(4):358-62.

  PMID: 9146927 RESULT

• Lewis NS. Comparisons between mammalian and artificial olfaction based on arrays of carbon black-polymer composite vapor detectors. Acc Chem Res. 2004 Sep;37(9):663-72. doi: 10.1021/ar030120m.

  PMID: 15379582 RESULT

• Fens N, Zwinderman AH, van der Schee MP, de Nijs SB, Dijkers E, Roldaan AC, Cheung D, Bel EH, Sterk PJ. Exhaled breath profiling enables discrimination of chronic obstructive pulmonary disease and asthma. Am J Respir Crit Care Med. 2009 Dec 1;180(11):1076-82. doi: 10.1164/rccm.200906-0939OC. Epub 2009 Aug 27.

  PMID: 19713445 RESULT

• American Thoracic Society; European Respiratory Society. ATS/ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. Am J Respir Crit Care Med. 2005 Apr 15;171(8):912-30. doi: 10.1164/rccm.200406-710ST. No abstract available.

  PMID: 15817806 RESULT

• Clement PA, Gordts F; Standardisation Committee on Objective Assessment of the Nasal Airway, IRS, and ERS. Consensus report on acoustic rhinometry and rhinomanometry. Rhinology. 2005 Sep;43(3):169-79.

  PMID: 16218509 RESULT

• Serrano C, Valero A, Picado C. [Nasal nitric oxide]. Arch Bronconeumol. 2004 May;40(5):222-30. doi: 10.1016/s1579-2129(06)70088-x. No abstract available. Spanish.

  PMID: 15117622 RESULT

MeSH Terms

Conditions

Rhinitis, Allergic; Common Cold; Nasal Polyps

Interventions

Electronic Nose

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Electrical Equipment and Supplies

Study Officials

• Lorena Soto-Retes, physician

  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2015
• First Posted: June 22, 2015
• Study Start: January 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 13, 2020

Record last verified: 2020-02

Locations

ES (1)