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

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ClinicalTrials.gov Identifier: NCT03145051
Recruitment Status : Active, not recruiting
First Posted : May 9, 2017
Last Update Posted : September 1, 2017
Sponsor:
Information provided by (Responsible Party):
Laboratoire de la Mer

November 15, 2016
May 9, 2017
September 1, 2017
January 2015
October 2017   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT03145051 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Efficacy of Nasal Irrigation With Respimer® Netiflow® vs Saline Among Patients With Cystic Fibrosis and Chronic Rhinosinusitis
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
  • Chronic Rhinosinusitis
  • Cystic Fibrosis
  • Other: Saline solution
    a nasal irrigation care
    Other Name: nasal irrigation care
  • Other: Respimer Netiflow
    a nasal irrigation care
    Other Name: nasal irrigation care
  • 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
    Intervention: Other: Respimer Netiflow
  • Active Comparator: Saline solution
    Nasal irrigation with saline solution , 4 times/day during 8 weeks using Respimer Netiflow class I medical device
    Intervention: Other: Saline solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
95
December 2017
October 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
11 Years to 65 Years   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT03145051
Laboratoiredelamer
No
Not Provided
Plan to Share IPD: No
Laboratoire de la Mer
Laboratoire de la Mer
Not Provided
Not Provided
Laboratoire de la Mer
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP