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

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

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.

Study Overview

• Status: Unknown
• Conditions: Cystic Fibrosis; Chronic Rhinosinusitis
• Intervention / Treatment: Other: Respimer Netiflow; Other: Saline solution

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Creteil, France, 94010
    • ORL et Chirurgie Cervico-faciale Centre Hospitalier Intercommunal (CHI) de Créteil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 63 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Respimer Netiflow mineral salts solution; Nasal irrigation with Respimer Netiflow mineral salts solution, 4 times/day during 8 weeks using Respimer Netiflow class I medical device	Other: Respimer Netiflow; a nasal irrigation care; Other Names: nasal irrigation care
Active Comparator: Saline solution; Nasal irrigation with saline solution , 4 times/day during 8 weeks using Respimer Netiflow class I medical device	Other: Saline solution; a nasal irrigation care; Other Names: nasal irrigation care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Laboratoire de la Mer

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: November 15, 2016
• First Submitted That Met QC Criteria: May 4, 2017
• First Posted (Actual): May 9, 2017

Study Record Updates

• Last Update Posted (Actual): September 1, 2017
• Last Update Submitted That Met QC Criteria: August 31, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: cystic fibrosis; chronic rhinosinusitis; nasal irrigation; minerals; saline solution
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Pancreatic Diseases; Fibrosis; Sinusitis; Cystic Fibrosis
• Other Study ID Numbers: Laboratoiredelamer

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No