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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
a nasal irrigation care
a nasal irrigation care
ORL et Chirurgie Cervico-faciale Centre Hospitalier Intercommunal (CHI) de Créteil
Créteil, France
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
Time frame: over an 8 weeks period
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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: over an 8 weeks period
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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
Time frame: 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
Time frame: over an 8 weeks period