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

Study Overview
=================
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.

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.

Official Title
-----------------
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.

Conditions
-----------------
Polyp of Ethmoidal Sinus, Surgery

Intervention / Treatment
-----------------
* Other: A postoperative care after ethmoid sinus surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A - Experimental<br>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<br>* 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).<br>|
| Active Comparator: B - Comparator<br>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<br>* 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).<br>|

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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Saline Solution, Isotonic / Administration & dosage, Therapeutic Irrigation / methods, Postoperative Care / methods, Quality of life