NCT02559284

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 24, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

September 1, 2017

Status Verified

August 1, 2017

Enrollment Period

1.8 years

First QC Date

September 22, 2015

Last Update Submit

August 31, 2017

Conditions

Polyp of Ethmoidal SinusSurgery

Keywords

Saline Solution, Isotonic / Administration & dosageTherapeutic Irrigation / methodsPostoperative Care / methodsQuality of life

Outcome Measures

Primary Outcomes (1)

  • Superior healing of nasal mucosa repair 14 days following endoscopic sinus surgery, between the RESPIMER® NetiFlow® solution and the saline solution arms

    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 Outcomes (8)

  • Efficacy in optimizing airway clearance and restoring respiratory health, as well as overall quality of life

    Pre-inclusion, D7, D14, D21 and D28

  • Assess and compare the crusting

    Pre-inclusion, D7, D14, D21 and D28

  • Assess and compare the tolerability

    Pre-inclusion, D7, D14, D21 and D28

  • Additional details on duration of nasal washes

    D7, D14, D21 and D28 after surgery

  • Satisfaction and perceived efficacy of the nasal solution

    D7, D14, D21 and D28 after surgery

  • +3 more secondary outcomes

Study Arms (2)

A - Experimental

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

B - Comparator

ACTIVE 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

Interventions

A postoperative care after ethmoid sinus surgeryOTHER

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).

A - ExperimentalB - Comparator

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Service d'Oto-rhino-laryngologie - Clinique Saint-Augustin

Bordeaux, Gironde, 33074, France

Location

Service d'Oto-rhino-laryngologie et Chirurgie cervico-faciale - Hôpital Pellegrin

Bordeaux, Gironde, 33076, France

Location

ORL et Chirurgie Cervico-faciale - Pôle Voies Respiratoires - CHU Toulouse

Toulouse, Haute-Garonne, 31059, France

Location

Service d'ORL et Chirurgie cervico faciale - CHRU Tours

Tours, Indre-et-Loire, 37044, France

Location

Service d'oto-rhino-laryngologie - CHU de Nantes

Nantes, Loire-Atlantique, 44093, France

Location

Service ORL et Chirurgie Cervico-faciale - CHRU Nancy

Nancy, Meurthe-et-Moselle, France

Location

Service ORL et Chirurgie cervico-faciale - CHRU Lille

Lille, Nord, 59037, France

Location

ORL et Chirurgie Cervico-faciale - Centre Hospitalier Intercommunal (CHI) de Créteil

Créteil, Val-de-Marne, 94010, France

Location

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Study Officials

  • Ludovic LE TAILLANDIER de GABORY, MD, PhD

    Coordinator Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2015

First Posted

September 24, 2015

Study Start

April 1, 2015

Primary Completion

February 1, 2017

Study Completion

May 1, 2017

Last Updated

September 1, 2017

Record last verified: 2017-08

Locations

FR(8)