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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2017 by Laboratoire de la Mer
Sponsor:
Information provided by (Responsible Party):
Laboratoire de la Mer
ClinicalTrials.gov Identifier:
NCT03145051
First received: November 15, 2016
Last updated: May 4, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention
Chronic Rhinosinusitis
Cystic Fibrosis
Other: Saline solution
Other: Respimer Netiflow

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Investigator
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Laboratoire de la Mer:

Primary Outcome Measures:
  • 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. [ Time Frame: 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:
  • 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. [ Time Frame: over an 8 weeks period ]
    Clinical status to be assessed after 4 and 8 weeks of nasal wash using Lund-Kennedy Symptomatic Score (LKSS)

  • 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. [ Time Frame: over an 8 weeks period ]
    Endoscopic status to be assessed after 4 and 8 weeks of nasal wash using Lund-Kennedy Endoscopic Score (LKES)

  • 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. [ Time Frame: over an 8 weeks period ]
    Mucociliary transport to be assessed after 4 and 8 weeks of nasal wash using saccharine test

  • 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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: over an 8 weeks period ]
    Adverse events to be assessed based on vigilance tracking during the whole study period


Estimated Enrollment: 95
Study Start Date: January 2015
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: nasal irrigation care

  Eligibility

Ages Eligible for Study:   11 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03145051

Contacts
Contact: Virginie ESCABASSE, MD 01 49 81 22 250 Virginie.Escabasse@chicreteil.fr

Locations
France
ORL et Chirurgie Cervico-faciale Centre Hospitalier Intercommunal (CHI) de Créteil Recruiting
Creteil, France, 94010
Contact: Virginie ESCABASSE    01 49 81 22 250    Virginie.Escabasse@chicreteil.fr   
Sponsors and Collaborators
Laboratoire de la Mer
  More Information

Responsible Party: Laboratoire de la Mer
ClinicalTrials.gov Identifier: NCT03145051     History of Changes
Other Study ID Numbers: Laboratoiredelamer
Study First Received: November 15, 2016
Last Updated: May 4, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Laboratoire de la Mer:
saline solution
minerals
cystic fibrosis
chronic rhinosinusitis
nasal irrigation

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Sinusitis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on May 25, 2017