The Diagnostics of Extraesophageal Reflux With the Restech System

NCT01819454 | Completed

• 2 other identifiers: FNO-ENT-EER RestechNT13500-4/2012
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the project is to define the frequency with which EER is present in patient with chronic rhinosinusitis (CHR). The measurement will be carried out with a 24-hour monitoring of the pH using the Restech system. This modern device is equipped with a narrow antimony probe. The sensor is able to record not only liquid but also aerosol reflux episodes. The second aim is to determine the relation among EER, CHR and asthma bronchiale. We will compare the presence of reflux in three different patient groups (1. CHR without nasal polyposis, without asthma bronchiale or ASA syndrome, 2. CHR with nasal polyposis, without asthma bronchiale or ASA syndrome, 3. CHR with nasal polyposis and asthma bronchiale and/or ASA syndrome). We expect to find a significantly more frequent presence of EER in patients with CHR and asthma bronchiale or ASA syndrome. In case our hypothesis is confirmed, it will be especially these patients(with a difficult to manage nasal polyposis) benefiting from the antireflux therapy.

Conditions

Nasal Diseases; Nasal Polyps; Laryngopharyngeal Reflux

Keywords

chronic rhinosinusitis; extraesophageal reflux; Restech system; antireflux therapy

Outcome Measures

Primary Outcomes (1)

• The frequency of the extraesophageal reflux in patients with chronic rhinosisnusitis

  EER will be measured using RYAN score, number of episodes and time of pH below 5.5

  3 years

Study Arms (3)

pH monitoring sinusitis no polyps

EXPERIMENTAL

30 patients with chronic rhinosinusitis without nasal polyposis, without asthma bronchiale or ASA syndrome

Device: pH monitoring (Restech)

pH monitoring sinusitis with polyp

EXPERIMENTAL

30 patients with chronic rhinosinusitis with nasal polyposis, without asthma bronchiale or ASA syndrome

Device: pH monitoring (Restech)

pH monitoring sinusitis, polyps, asthma

EXPERIMENTAL

30 patients with chronic rhinosinusitis with nasal polyposis and with asthma bronchiale and/or ASA syndrome

Device: pH monitoring (Restech)

Interventions

pH monitoring (Restech) DEVICE

see in "detail description of the study" part of the protocol

Also known as: oropharyngeal pH monitoring using Restech system

pH monitoring sinusitis no polyps; pH monitoring sinusitis with polyp; pH monitoring sinusitis, polyps, asthma

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• signing of the informed consent
• patients with chronic rhinosinusitis

You may not qualify if:

• non-tolerance of the pH catheter

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70800, Czechia

Location

Related Publications (5)

• DelGaudio JM. Direct nasopharyngeal reflux of gastric acid is a contributing factor in refractory chronic rhinosinusitis. Laryngoscope. 2005 Jun;115(6):946-57. doi: 10.1097/01.MLG.0000163751.00885.63.

  PMID: 15933499 BACKGROUND

• Katle EJ, Hatlebakk JG, Steinsvag S. Gastroesophageal reflux and rhinosinusitis. Curr Allergy Asthma Rep. 2013 Apr;13(2):218-23. doi: 10.1007/s11882-013-0340-5.

  PMID: 23371037 BACKGROUND

• Loehrl TA, Samuels TL, Poetker DM, Toohill RJ, Blumin JH, Johnston N. The role of extraesophageal reflux in medically and surgically refractory rhinosinusitis. Laryngoscope. 2012 Jul;122(7):1425-30. doi: 10.1002/lary.23283. Epub 2012 Apr 26.

  PMID: 22539181 BACKGROUND

• Hanna BC, Wormald PJ. Gastroesophageal reflux and chronic rhinosinusitis. Curr Opin Otolaryngol Head Neck Surg. 2012 Feb;20(1):15-8. doi: 10.1097/MOO.0b013e32834e8f11.

  PMID: 22157165 BACKGROUND

• Zelenik K, Matousek P, Formanek M, Urban O, Kominek P. Patients with chronic rhinosinusitis and simultaneous bronchial asthma suffer from significant extraesophageal reflux. Int Forum Allergy Rhinol. 2015 Oct;5(10):944-9. doi: 10.1002/alr.21560. Epub 2015 Jun 5.

  PMID: 26046448 DERIVED

MeSH Terms

Conditions

Nose Diseases; Nasal Polyps; Laryngopharyngeal Reflux

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Laryngeal Diseases

Study Officials

• Karol Zelenik, MD,PhD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 22, 2013
• First Posted: March 27, 2013
• Study Start: August 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 8, 2016

Record last verified: 2016-09

Locations

CZ (1)