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

Not Applicable

• Conditions: Cystic Fibrosis; Chronic Rhinosinusitis

• Registration Number: NCT03145051
• Lead Sponsor: Laboratoire de la Mer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-11-15
• Study First Submitted QC: 2017-05-04
• Study First Posted: 2017-05-09
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-31
• Last Update Posted: 2017-09-01
• Primary Completion: 2017-10
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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
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)
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
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

Trial Locations

Locations (1)

ORL et Chirurgie Cervico-faciale Centre Hospitalier Intercommunal (CHI) de Créteil; 🇫🇷 Creteil, France