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

Laboratoire de la Mer

Status: Unknown

Conditions: Chronic Rhinosinusitis; Cystic Fibrosis

Treatments: Other: Respimer Netiflow; Other: Saline solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT03145051

Laboratoiredelamer

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 11 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Respimer Netiflow mineral salts solution

Experimental group

Description:

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

Treatment:

Other: Respimer Netiflow

Saline solution

Active Comparator group

Description:

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

Treatment:

Other: Saline solution