Chronic Rhinosinusitis, Cystic Fibrosis
Conditions
Keywords
saline solution, minerals, cystic fibrosis, chronic rhinosinusitis, nasal irrigation
Brief summary
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.
Interventions
OTHERSaline solution
a nasal irrigation care
OTHERRespimer Netiflow
a nasal irrigation care
Sponsors
Laboratoire de la Mer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
11 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | over an 8 weeks period | Quality of life to be assessed over an 8 weeks period of nasal wash using SNOT-20 questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | over an 8 weeks period | Endoscopic status to be assessed after 4 and 8 weeks of nasal wash using Lund-Kennedy Endoscopic Score (LKES) |
| 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. | over an 8 weeks period | Mucociliary transport to be assessed after 4 and 8 weeks of nasal wash using saccharine test |
| 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. | over an 8 weeks period | Clinical status to be assessed after 4 and 8 weeks of nasal wash using Lund-Kennedy Symptomatic Score (LKSS) |
| Patient treatment acceptance of nasal irrigation with Respimer® Netiflow® medical device | over an 8 weeks period | Patient treatment acceptance to be assessed by Morisky score after 4 and 8 weeks of nasal wash |
| Occurrence of adverse events : taste impairment, epistaxis, nasal irritations, nasal burning | over an 8 weeks period | Adverse events to be assessed based on vigilance tracking during the whole study 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. | over an 8 weeks period | Evolution of nasal bacterial pathogens to be assessed by bacteriologic swab within ethmoid nasal cavities after 4 and 8 weeks of nasal wash |
Countries
France
Outcome results
None listed