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. 2019 Oct 23;2019(10):CD012979. doi: 10.1002/14651858.CD012979.pub2

NCT03145051.

Methods RCT
 Parallel assignment, cross‐over trial
Single blinded
Duration: 8 weeks
Participants 50 participants, aged between 11 and 65 years
Inclusion criteria
  • Cystic fibrosis with or without lung transplantion

  • Allergic chronic rhinosinusitis 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.

  • Treated on an outpatient basis

  • No sea baths for the duration of the study

  • Respect the procedures for conducting the study, in particular the washout period and follow‐up visits

  • Capable of understanding and self‐completing the questionnaires;

  • For juveniles, 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
  • 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

  • Signs of severity that may require hospitalization, such as: severe impairment of general health, dyspnoea with cyanosis, high fever (> 40 ° C)

  • Corticosteroid therapy required during the study, with the exception of those who received pulmonary transplant and were treated with oral corticosteroids at no more than 0.2 mg / kg / day

  • Known systemic immunodeficiency status with the exception of those receiving pulmonary transplantation and immunosuppressed

  • Pregnant (urine test) or without effective contraception (birth control pill, contraceptive patch, contraceptive implant, vaginal ring, intrauterine device or intrauterine device, male condom).

  • Nursing

  • Contraindication to nasal irrigations as defined in the product leaflet

Interventions Treatment arm
Nasal irrigation with Respimer Netiflow mineral salts solution, 4 times/day during 8 weeks using Respimer Netiflow class I medical device
Control arm
Nasal irrigation with saline solution, 4 times/day during 8 weeks using Respimer Netiflow class I medical device
Outcomes Primary outcome
  • Quality of life assessed over an 8 weeks period of nasal wash using SNOT‐20 questionnaire


Secondary outcome
  • Clinical status assessed after 4 and 8 weeks of nasal wash using Lund‐Kennedy Symptomatic Score (LKSS)

  • Endoscopic status assessed after 4 and 8 weeks of nasal wash using Lund‐Kennedy Endoscopic Score (LKES)

  • Mucociliary transport assessed after 4 and 8 weeks of nasal wash using saccharine test

  • Evolution of nasal bacterial pathogens assessed by bacteriologic swab within ethmoid nasal cavities after 4 and 8 weeks of nasal wash

  • Patient treatment acceptance assessed by Morisky score after 4 and 8 weeks of nasal wash

  • Adverse events assessed based on vigilance tracking during the whole study period ‐ taste impairment, epistaxis, nasal irritations, nasal burn

Notes This trial was undertaken by Laboratoire de la Mer between January 2015 and December 2017. The results of this trial are not retrievable. We are trying to contact the primary investigator for further information.

RCT: randomized controlled trial