Allergic Rhinitis Clinical Trial
— EPONAOfficial title:
AssEssment and New Perspectives on Pathophysiogenesis, detectiOn and Use of NAsal Nitrous Oxide and the Electronic Nose (EPONA Project)
Verified date | February 2020 |
Source | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 139 |
Est. completion date | December 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion criteria: 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. - No acute infectious process during the four weeks preceding the study. - Signed informed consent. Exclusion criteria for all groups: - 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Lorena Soto-Retes | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Sociedad Española de Alergología e Inmunología Clínica, Sociedad Española de Neumología y Cirugía Torácica, Universitat Autonoma de Barcelona |
Spain,
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 — View Citation
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. — View Citation
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. — View Citation
Dötsch J, Demirakça S, Terbrack HG, Hüls G, Rascher W, Kühl PG. Airway nitric oxide in asthmatic children and patients with cystic fibrosis. Eur Respir J. 1996 Dec;9(12):2537-40. — View Citation
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. Epub 2007 Jul 20. — View Citation
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 — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
Lundberg JO, Farkas-Szallasi T, Weitzberg E, Rinder J, Lidholm J, Anggåard A, Hökfelt T, Lundberg JM, Alving K. High nitric oxide production in human paranasal sinuses. Nat Med. 1995 Apr;1(4):370-3. — View Citation
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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. Review. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Values of nNO measure as parts per billions (ppb) | 12 months | ||
Primary | Values of the electronic nose measure as volatile organic compounts (VOCs) | 12 months |
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