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

NCT ID: NCT03145051

Last Updated: 2017-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-12-31

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.

Conditions

Chronic Rhinosinusitis; Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Respimer Netiflow

Intervention Type: OTHER

a nasal irrigation care

Saline solution

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

Group Type: ACTIVE_COMPARATOR

Saline solution

Intervention Type: OTHER

a nasal irrigation care

Interventions

Saline solution

a nasal irrigation care

Intervention Type: OTHER

Respimer Netiflow

a nasal irrigation care

Intervention Type: OTHER

Other Intervention Names

nasal irrigation care; 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.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratoire de la Mer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Créteil, , France

Countries

France

Other Identifiers

Laboratoiredelamer

Identifier Type: -

Identifier Source: org_study_id