Clinical trial NCT03145051: Efficacy of Nasal Irrigation With Respimer® Netiflow® vs Saline Among Patients With Cystic Fibrosis and Chronic Rhinosinusitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Rhinosinusitis
Cystic Fibrosis
Keywords: saline solution
minerals
cystic fibrosis
chronic rhinosinusitis
nasal irrigation
Lead sponsor: Laboratoire de la Mer
Sponsor class: INDUSTRY
First posted: 2017-05-09
Enrollment: 50
Sex: ALL
Minimum age (years): 11
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: over an 8 weeks period
Secondary outcomes:
measure: 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.
timeFrame: over an 8 weeks period
measure: 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.
timeFrame: over an 8 weeks period
measure: 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.
timeFrame: over an 8 weeks period
measure: 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.
timeFrame: over an 8 weeks period
measure: Patient treatment acceptance of nasal irrigation with Respimer® Netiflow® medical device
timeFrame: over an 8 weeks period
measure: Occurrence of adverse events : taste impairment, epistaxis, nasal irritations, nasal burning
timeFrame: over an 8 weeks period
Other outcomes:
Locations:
city: Creteil
country: France
facility: ORL et Chirurgie Cervico-faciale Centre Hospitalier Intercommunal (CHI) de Créteil
Study officials:
References: