RESPIMER® Netiflow® vs. Saline Solutions During Nasal Irrigation Following Bilateral Ethmoidectomy (Nasal Polyposis) (NETIFLOW)

August 31, 2017 updated by: Laboratoire de la Mer

A Comparative, Multicenter and Randomized Study Evaluating the Safety and Efficacy of RESPIMER® Netiflow® Versus Saline Solutions During Nasal Irrigation Following Bilateral Ethmoidectomy in the Treatment of Nasal Polyposis.

The main objective of this study is to compare the effects of RESPIMER® NetiFlow® solution and device versus saline solution (0.9% NaCl), the standard treatment, used with RESPIMER® NetiFlow® device, both used postoperative care, in the context of ethmoid sinus surgery, at 14 days post-surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a comparative study between two postoperative treatments following ethmoid sinus surgery. The purpose of this study is to compare the effect of RESPIMER® NetiFlow® solution on nasal tissue repair versus saline solution (0.9% NaCl), the standard treatment.

The type of surgery selected for this study is total endoscopic ethmoidectomy. This is a frequently used standard surgery that requires nasal cleansing for an average of 28 days. This process allows the regeneration of the nasal epithelial lining of the wound (areas of exposed bone), as well as the healing of swelling and scarring due to the surgery.

The follow up last 28 days with 4 visits (D7, D14, D21 and D28).

RESPIMER® NetiFlow® : device of class I, with CE mark, in the indication of sinus postoperative care.

Study Type

Interventional

Enrollment (Actual)

189

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Gironde
      • Bordeaux, Gironde, France, 33074
        • Service d'Oto-rhino-laryngologie - Clinique Saint-Augustin
      • Bordeaux, Gironde, France, 33076
        • Service d'Oto-rhino-laryngologie et Chirurgie cervico-faciale - Hôpital Pellegrin
    • Haute-Garonne
      • Toulouse cedex 9, Haute-Garonne, France, 31059
        • ORL et Chirurgie Cervico-faciale - Pôle Voies Respiratoires - CHU Toulouse
    • Indre-et-Loire
      • Tours cedex 1, Indre-et-Loire, France, 37044
        • Service d'ORL et Chirurgie cervico faciale - CHRU Tours
    • Loire-Atlantique
      • Nantes Cedex 1, Loire-Atlantique, France, 44093
        • Service d'oto-rhino-laryngologie - CHU de Nantes
    • Meurthe-et-Moselle
      • Nancy CEDEX, Meurthe-et-Moselle, France
        • Service ORL et Chirurgie Cervico-faciale - CHRU Nancy
    • Nord
      • Lille cedex, Nord, France, 59037
        • Service ORL et Chirurgie cervico-faciale - CHRU Lille
    • Val-de-Marne
      • Créteil cedex, Val-de-Marne, France, 94010
        • ORL et Chirurgie Cervico-faciale - Centre Hospitalier Intercommunal (CHI) de Créteil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males or females between 18 and 65 years of age

  • Subject in need of sinus surgery as bilateral total ethmoidectomy using an endoscopic endonasal approach whose pathology is the result of a:

    • Sinonasal polyposis alone
    • Sinonasal polyposis associated with asthma and / or intolerance to NSAIDs
  • Free and informed written consent
  • Member or beneficiary of a social security program

Exclusion Criteria:

  • Oral corticosteroid treatment since less than 2 months
  • Premenopausal women not using effective contraception (oral or intrauterine device)
  • Pregnant or nursing women
  • Uncontrolled diabetes (not treated or stabilized by treatment)
  • HIV-positive status
  • Autoimmune diseases affecting the nose and/or sinuses, immune dysfunctions (Wegener's granulomatosis, Churg-Strauss syndrome, Common Variable Immunodeficiency, sarcoidosis...), or malignant diseases (unclear histology)
  • All contraindication of RESPIMER® NetiFlow®
  • All diseases resulting in difficulty coughing or swallowing
  • Ongoing or past radiation treatment to the head and neck
  • Ongoing or recent chemotherapy (within a three-month period)
  • Subjects using anticoagulants
  • Subjects taking part in another study that includes an exclusion period coinciding with that of the run-in period of this study
  • Subjects placed under judicial protection
  • Subjects who suffer from severe physical or psychological problems and whose condition can, according to the investigator, affect compliance with the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A - Experimental
Treatment Arm: 100 patients using Respimer® NetiFlow® solution as standard treatment for healing of nasal surgery wounds following an endoscopic ethmoidectomy as a postoperative care after ethmoid sinus surgery
Other: A postoperative care after ethmoid sinus surgery

A comparison of two products used for nasal cavity cleansing, at the rate of 4 washes/day (240mL per wash), as local postoperative care following endoscopic sinus surgery. This surgery, known as an ethmoidectomy, aims to improve sinus ventilation, treat the chronically infected area, and remove polyps that cause nasal obstruction.

Detailed information concerning the purpose of nasal irrigation, as well as how to use and clean the device, will be given to patients upon inclusion.

The nasal washing procedure will be as follow:

  • Washing both nostrils using 180mL of solution distributed equally on each side to remove crusting and clotting
  • Gentle blowing of the nose
  • Rinsing both nostrils with the remaining 60mL of solution distributed equally on each side (no nose-blowing).
Active Comparator: B - Comparator
Control Arm: 100 patients using saline solution (0.9% NaCl) as standard treatment for healing of nasal surgery wounds following an endoscopic ethmoidectomy as a postoperative care after ethmoid sinus surgery
Other: A postoperative care after ethmoid sinus surgery

A comparison of two products used for nasal cavity cleansing, at the rate of 4 washes/day (240mL per wash), as local postoperative care following endoscopic sinus surgery. This surgery, known as an ethmoidectomy, aims to improve sinus ventilation, treat the chronically infected area, and remove polyps that cause nasal obstruction.

Detailed information concerning the purpose of nasal irrigation, as well as how to use and clean the device, will be given to patients upon inclusion.

The nasal washing procedure will be as follow:

  • Washing both nostrils using 180mL of solution distributed equally on each side to remove crusting and clotting
  • Gentle blowing of the nose
  • Rinsing both nostrils with the remaining 60mL of solution distributed equally on each side (no nose-blowing).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Superior healing of nasal mucosa repair 14 days following endoscopic sinus surgery, between the RESPIMER® NetiFlow® solution and the saline solution arms
Time Frame: D14 meaning 14 days (plus or minus 3 days) after surgery
Based on a ≥8 points difference in the total RHINO QoL score between the two groups.
D14 meaning 14 days (plus or minus 3 days) after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy in optimizing airway clearance and restoring respiratory health, as well as overall quality of life
Time Frame: Pre-inclusion, D7, D14, D21 and D28

Compare the efficacy of RESPIMER® NetiFlow® versus saline solutions in optimizing airway clearance and restoring respiratory health, as well as overall quality of life using:

  • RHINO QoL scores (a self-report of nasal congestion, facial pain, anterior and posterior rhinorrhea).
  • NOSE nasal obstruction scores.
Pre-inclusion, D7, D14, D21 and D28
Assess and compare the crusting
Time Frame: Pre-inclusion, D7, D14, D21 and D28

Assess and compare the crusting with :

  • The number of patients with (whether or not obstruction exists) and without crusting.
  • How many days it takes for the crusting to disappear and/or the difference in the total number of care days
Pre-inclusion, D7, D14, D21 and D28
Assess and compare the tolerability
Time Frame: Pre-inclusion, D7, D14, D21 and D28
Assess and compare the tolerability of RESPIMER® NetiFlow® versus saline solutions using a Visual Analog Scale (VAS) (burning sensation in the nose, alterations in taste and smell and epistaxis) (patient record).
Pre-inclusion, D7, D14, D21 and D28
Additional details on duration of nasal washes
Time Frame: D7, D14, D21 and D28 after surgery
Provide additional details on the duration of nasal washes according to the approved indication (patient record).
D7, D14, D21 and D28 after surgery
Satisfaction and perceived efficacy of the nasal solution
Time Frame: D7, D14, D21 and D28 after surgery
VAS numerical values assessing the level of patient satisfaction and perceived efficacy in regard to the nasal solution that was used by each group (patient's Case report Form).
D7, D14, D21 and D28 after surgery
Satisfaction, convenience, ease of administration and ease of cleaning of the RESPIMER® NetiFlow® device
Time Frame: D7, D14, D21 and D28 after surgery
VAS numerical values assessing the RESPIMER® NetiFlow® device in terms of satisfaction, convenience, ease of administration and ease of cleaning (patient's Case report Form).
D7, D14, D21 and D28 after surgery
Assess functionality of nasal lining
Time Frame: D-1, D14, and D21

Assess functionality of nasal lining by evaluating mucociliary clearance by rhinoscintigraphy for all patients in the 2 Bordeaux centers' (Bordeaux University Hospital and Saint-Augustin Private Hospital):

  • D-1 only for center's Bordeaux, 10 patients in each group (20 patients in total)
  • D14 and D21 for all Bordeaux patients', estimated at 50 patients (15 in each group and in addition the same 10 patients of the D-1 visit, in each group).
D-1, D14, and D21
Efficacy in improving the trophicity of the nasal mucosa within the operated area
Time Frame: D14, D21 and D28
Assess the efficacy of RESPIMER® NetiFlow® versus saline solutions in improving the trophicity of the nasal mucosa within the operated area, using a Lund-Kennedy endoscopic score (20 points).
D14, D21 and D28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoire de la Mer

Investigators

  • Principal Investigator: Ludovic LE TAILLANDIER de GABORY, MD, PhD, Coordinator Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

September 22, 2015

First Submitted That Met QC Criteria

September 22, 2015

First Posted (Estimate)

September 24, 2015

Study Record Updates

Last Update Posted (Actual)

September 1, 2017

Last Update Submitted That Met QC Criteria

August 31, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P0013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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