Efficacy of Nasal Irrigation With Respimer® Netiflow® vs Saline Among Patients With Cystic Fibrosis and Chronic Rhinosinusitis

Study Overview
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Brief Summary
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Prospective, randomized, cross-over, multicenter, trial comparing the efficacy and tolerability of nasal irrigation with Respimer® mineral salts solution versus saline solution both administered with Respimer® Netiflow® medical device among patients aged ≥ 11 years and older with cystic fibrosis and suffering from chronic rhinosinusitis.

Official Title
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Prospective, Randomized, Cross-over, Multicenter, Trial Comparing the Efficacy and Tolerability of Nasal Irrigation With Respimer® Netiflow® Mineral Salts Solution Versus Saline Among Patients With Cystic Fibrosis and Suffering From Chronic Rhinosinusitis

Conditions
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Chronic Rhinosinusitis, Cystic Fibrosis

Intervention / Treatment
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* Other: Saline solution
* Other: Respimer Netiflow


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Patient with Cystic Fibrosis with or without lung transplant; Patients with allergic chronic rhino sinusitis or no allergic diagnosed by the clinical investigator on the basis of the following signs in variable combination: nasal congestion, headache, sneezing, itchy nose and eyes, runny nose, nosebleeds and nasal crusts, redness and eye discharge present more than 3 months per year. Patient treated on an outpatient basis; Patient agreeing not to take sea baths for the duration of the study; Patient agreeing to respect the procedures for conducting the study, in particular the washout period and follow-up visits; Patient capable of understanding and self-completing the questionnaires; For juvenile patients, the holder (s) of parental authority have accepted the participation of the young person (by signing the informed consent after having taken note of the information note) Member or beneficiary of a social security program Exclusion Criteria: Patients with significant obstruction of the nasal passages due to: a mucocele, polyposis causing nasal obstruction> 90% or severe malformation of the septum causing a nasal obstruction> 90% in whom surgical treatment is recommended; Patients with signs of severity that may require hospitalization, such as: severe impairment of general health, dyspnoea with cyanosis, high fever (> 40 ° C). Patients requiring corticosteroid therapy during the study, with the exception of patients who received pulmonary transplant and were treated with oral corticosteroids at no more than 0.2 mg / kg / day. Patients with known systemic immunodeficiency status with the exception of patients receiving pulmonary transplantation and immunosuppressed. Patient pregnant (urine test) or without effective contraception (birth control pill, contraceptive patch, contraceptive implant, vaginal ring, intrauterine device or intrauterine device, male condom). Nursing patient. Patient with a contraindication to nasal irrigations as defined in the product leaflet.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Respimer Netiflow mineral salts solution<br>Nasal irrigation with Respimer Netiflow mineral salts solution, 4 times/day during 8 weeks using Respimer Netiflow class I medical device | Other: Respimer Netiflow<br>* a nasal irrigation care<br>* Other names: nasal irrigation care;|
| Active Comparator: Saline solution<br>Nasal irrigation with saline solution , 4 times/day during 8 weeks using Respimer Netiflow class I medical device | Other: Saline solution<br>* a nasal irrigation care<br>* Other names: nasal irrigation care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life among subjects undergoing nasal irrigation with Respimer® Netiflow® mineral salts solution compared to saline solution between inclusion and the end of treatment period. | Quality of life to be assessed over an 8 weeks period of nasal wash using SNOT-20 questionnaire | over an 8 weeks period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical status evolution among subjects undergoing nasal irrigation with Respimer® Netiflow® mineral salts solution to saline solution between inclusion and the end of treatment period. | Clinical status to be assessed after 4 and 8 weeks of nasal wash using Lund-Kennedy Symptomatic Score (LKSS) | over an 8 weeks period | 
| Endoscopic status evolution among subjects undergoing nasal irrigation with Respimer® Netiflow® mineral salts solution to saline solution between inclusion and the end of treatment period. | Endoscopic status to be assessed after 4 and 8 weeks of nasal wash using Lund-Kennedy Endoscopic Score (LKES) | over an 8 weeks period | 
| Mucociliary transport change among subjects undergoing nasal irrigation with Respimer® Netiflow® mineral salts solution to saline solution between inclusion and the end of treatment period. | Mucociliary transport to be assessed after 4 and 8 weeks of nasal wash using saccharine test | over an 8 weeks period | 
| Evolution of nasal bacterial pathogens among subjects undergoing nasal irrigation with Respimer® Netiflow® mineral salts solution to saline solution between inclusion and the end of treatment period. | Evolution of nasal bacterial pathogens to be assessed by bacteriologic swab within ethmoid nasal cavities after 4 and 8 weeks of nasal wash | over an 8 weeks period | 
| Patient treatment acceptance of nasal irrigation with Respimer® Netiflow® medical device | Patient treatment acceptance to be assessed by Morisky score after 4 and 8 weeks of nasal wash | over an 8 weeks period | 
| Occurrence of adverse events : taste impairment, epistaxis, nasal irritations, nasal burning | Adverse events to be assessed based on vigilance tracking during the whole study period | over an 8 weeks period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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minerals, cystic fibrosis, chronic rhinosinusitis, nasal irrigation, saline solution