Efficacy of Nasal Irrigation With Respimer® Netiflow® vs Saline Among Patients With Cystic Fibrosis and Chronic Rhinosinusitis (Respire)
Primary Purpose
Chronic Rhinosinusitis, Cystic Fibrosis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Saline solution
Respimer Netiflow
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Rhinosinusitis focused on measuring saline solution, minerals, cystic fibrosis, chronic rhinosinusitis, nasal irrigation
Eligibility 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.
Sites / Locations
- ORL et Chirurgie Cervico-faciale Centre Hospitalier Intercommunal (CHI) de Créteil
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Respimer Netiflow mineral salts solution
Saline solution
Arm Description
Nasal irrigation with Respimer Netiflow mineral salts solution, 4 times/day during 8 weeks using Respimer Netiflow class I medical device
Nasal irrigation with saline solution , 4 times/day during 8 weeks using Respimer Netiflow class I medical device
Outcomes
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.
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.
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.
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.
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.
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
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
Adverse events to be assessed based on vigilance tracking during the whole study period
Full Information
NCT ID
NCT03145051
First Posted
November 15, 2016
Last Updated
August 31, 2017
Sponsor
Laboratoire de la Mer
1. Study Identification
Unique Protocol Identification Number
NCT03145051
Brief Title
Efficacy of Nasal Irrigation With Respimer® Netiflow® vs Saline Among Patients With Cystic Fibrosis and Chronic Rhinosinusitis
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (Actual)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoire de la Mer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis, Cystic Fibrosis
Keywords
saline solution, minerals, cystic fibrosis, chronic rhinosinusitis, nasal irrigation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Respimer Netiflow mineral salts solution
Arm Type
Experimental
Arm Description
Nasal irrigation with Respimer Netiflow mineral salts solution, 4 times/day during 8 weeks using Respimer Netiflow class I medical device
Arm Title
Saline solution
Arm Type
Active Comparator
Arm Description
Nasal irrigation with saline solution , 4 times/day during 8 weeks using Respimer Netiflow class I medical device
Intervention Type
Other
Intervention Name(s)
Saline solution
Other Intervention Name(s)
nasal irrigation care
Intervention Description
a nasal irrigation care
Intervention Type
Other
Intervention Name(s)
Respimer Netiflow
Other Intervention Name(s)
nasal irrigation care
Intervention Description
a nasal irrigation care
Primary Outcome Measure Information:
Title
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.
Description
Quality of life to be assessed over an 8 weeks period of nasal wash using SNOT-20 questionnaire
Time Frame
over an 8 weeks period
Secondary Outcome Measure Information:
Title
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.
Description
Clinical status to be assessed after 4 and 8 weeks of nasal wash using Lund-Kennedy Symptomatic Score (LKSS)
Time Frame
over an 8 weeks period
Title
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.
Description
Endoscopic status to be assessed after 4 and 8 weeks of nasal wash using Lund-Kennedy Endoscopic Score (LKES)
Time Frame
over an 8 weeks period
Title
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.
Description
Mucociliary transport to be assessed after 4 and 8 weeks of nasal wash using saccharine test
Time Frame
over an 8 weeks period
Title
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.
Description
Evolution of nasal bacterial pathogens to be assessed by bacteriologic swab within ethmoid nasal cavities after 4 and 8 weeks of nasal wash
Time Frame
over an 8 weeks period
Title
Patient treatment acceptance of nasal irrigation with Respimer® Netiflow® medical device
Description
Patient treatment acceptance to be assessed by Morisky score after 4 and 8 weeks of nasal wash
Time Frame
over an 8 weeks period
Title
Occurrence of adverse events : taste impairment, epistaxis, nasal irritations, nasal burning
Description
Adverse events to be assessed based on vigilance tracking during the whole study period
Time Frame
over an 8 weeks period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
ORL et Chirurgie Cervico-faciale Centre Hospitalier Intercommunal (CHI) de Créteil
City
Creteil
ZIP/Postal Code
94010
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Nasal Irrigation With Respimer® Netiflow® vs Saline Among Patients With Cystic Fibrosis and Chronic Rhinosinusitis
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