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

NCT03145051 | Unknown

• 1 other identifier: Laboratoiredelamer
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Rhinosinusitis; Cystic Fibrosis

Keywords

saline solution; minerals; cystic fibrosis; chronic rhinosinusitis; nasal irrigation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• 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

• 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

• 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

• Patient treatment acceptance of nasal irrigation with Respimer® Netiflow® medical device

  over an 8 weeks period

Study Arms (2)

Respimer Netiflow mineral salts solution

EXPERIMENTAL

Nasal irrigation with Respimer Netiflow mineral salts solution, 4 times/day during 8 weeks using Respimer Netiflow class I medical device

Other: Respimer Netiflow

Saline solution

ACTIVE COMPARATOR

Nasal irrigation with saline solution , 4 times/day during 8 weeks using Respimer Netiflow class I medical device

Other: Saline solution

Interventions

Saline solution OTHER

a nasal irrigation care

Also known as: nasal irrigation care

Saline solution

Respimer Netiflow OTHER

a nasal irrigation care

Also known as: nasal irrigation care

Respimer Netiflow mineral salts solution

Eligibility Criteria

• Age: 11 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratoire de la Mer: lead

Study Sites (1)

ORL et Chirurgie Cervico-faciale Centre Hospitalier Intercommunal (CHI) de Créteil

Créteil, 94010, France

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2016
• First Posted: May 9, 2017
• Study Start: January 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 1, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)