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

Cystic Fibrosis Clinical Trial

— Respire  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03145051
• Other study ID #: Laboratoiredelamer
• Status: Active, not recruiting
• Phase: N/A
• First received: November 15, 2016
• Last updated: August 31, 2017
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: August 2017
• Source: Laboratoire de la Mer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Rhinosinusitis
• Cystic Fibrosis
• Fibrosis
• Sinusitis

Intervention

Other:
• Saline solution
a nasal irrigation care
• Respimer Netiflow
a nasal irrigation care

Locations

Country	Name	City	State
France	ORL et Chirurgie Cervico-faciale Centre Hospitalier Intercommunal (CHI) de Créteil	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoire de la Mer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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