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

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

Sponsors

Lead sponsor: Laboratoire de la Mer

Source Laboratoire de la Mer
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.

Overall Status Unknown status
Start Date January 2015
Completion Date December 2017
Primary Completion Date October 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure 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. over an 8 weeks period
Secondary Outcome
Measure 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. 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
Occurrence of adverse events : taste impairment, epistaxis, nasal irritations, nasal burning over an 8 weeks period
Enrollment 50
Condition
Intervention

Intervention type: Other

Intervention name: Saline solution

Description: a nasal irrigation care

Arm group label: Saline solution

Other name: nasal irrigation care

Intervention type: Other

Intervention name: Respimer Netiflow

Description: a nasal irrigation care

Arm group label: Respimer Netiflow mineral salts solution

Other name: nasal irrigation care

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.

Gender: All

Minimum age: 11 Years

Maximum age: 65 Years

Healthy volunteers: No

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

France

Verification Date

August 2017

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Respimer Netiflow mineral salts solution

Arm group type: Experimental

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

Arm group label: Saline solution

Arm group type: Active Comparator

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

Acronym Respire
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Treatment

Masking: Single (Investigator)

Source: ClinicalTrials.gov