CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 139 enrolled
Drug / intervention
Nasal nitrous oxide +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02476929
NCT02476929N/ACompleted

AssEssment and New Perspectives on Pathophysiogenesis, detectiOn and Use of NAsal Nitrous Oxide and the Electronic Nose (EPONA Project)

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau·interventional·Posted Jun 22, 2015·Updated Feb 13, 2020

In Brief

A clinical study evaluating Nasal nitrous oxide and Electronic nose for Allergic Rhinitis and 2 related conditions. Completed, enrolled 139 participants across 1 site.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 22, 2015
Enrollment StartJan 1, 2013
Primary CompletionJul 1, 2016
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 11.0 years ago

Interventions

Nasal nitrous oxidedevice

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

Electronic nosedevice

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