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J Cyst Fibros. 2016 Nov;15(6):e57-e66. doi: 10.1016/j.jcf.2016.05.003. Epub 2016 Jun 5.

Sino nasal inhalation of isotonic versus hypertonic saline (6.0%) in CF patients with chronic rhinosinusitis - Results of a multicenter, prospective, randomized, double-blind, controlled trial.

Author information

  • 1Jena University Hospital, CF Centre, Jena, Germany. Electronic address: Jochen.Mainz@med.uni-jena.de.
  • 2Jena University Hospital, Institute of Medical Statistics and Documentation, Jena, Germany. Electronic address: Ulrike.Schumacher@med.uni-jena.de.
  • 3Jena University Hospital, CF Centre, Jena, Germany. Electronic address: Katja.Schaedlich@med.uni-jena.de.
  • 4Jena University Hospital, CF Centre, Jena, Germany; Institute of Human Genetics, University of Leipzig Hospitals and Clinics, Leipzig, Germany. Electronic address: Julia.Hentschel@medizin.uniklinikum-leipzig.de.
  • 5Klinikum Stuttgart, Pediatric Otorhinolaryngology, Stuttgart, Germany. Electronic address: c.koitschev@klinikum-stuttgart.de.
  • 6Klinikum Stuttgart, Pediatric Otorhinolaryngology, Stuttgart, Germany. Electronic address: a.koitschev@klinikum-stuttgart.de.
  • 7Tübingen University Hospital, Pediatric CF Centre, Tübingen, Germany. Electronic address: Joachim.riethmueller@med.uni-tuebingen.de.
  • 8Leipzig University Hospital, Pediatric Pneumology/Allergy, Leipzig, Germany. Electronic address: freerk.prenzel@uniklinik-leipzig.de.
  • 9Heidelberg University Hospital, Pediatric CF Centre, Heidelberg, Germany. Electronic address: olaf.sommerburg@med.uni-heidelberg.de.
  • 10Institute for Medical Informatics and Biometry, Technical University of Dresden, Germany. Electronic address: Baerbel.Wiedemann@tu-dresden.de.
  • 11Charite' University Hospital Berlin, CF Centre, Berlin, Germany. Electronic address: doris.staab@charite.de.
  • 12Frankfurt University Hospital, Pneumology/Allergology, Frankfurt, Germany. Electronic address: Wolfgang.Gleiber@kgu.de.
  • 13München University Hospital, CF Centre, München, Germany. Electronic address: rainald.fischer@gmail.com.
  • 14Jena University Hospital, CF Centre, Jena, Germany. Electronic address: James.Beck@med.uni-jena.de.
  • 15Jena University Hospital, CF Centre, Jena, Germany. Electronic address: Christin.Arnold@med.uni-jena.de.
  • 16Jena University Hospital, CF Centre, Jena, Germany.
  • 17Leipzig University Hospital, Pediatric Pneumology/Allergy, Leipzig, Germany.
  • 18Frankfurt University Hospital, Pneumology/Allergology, Frankfurt, Germany.
  • 19Münster University Hospital, Pediatric Pneumology, Münster, Germany.
  • 20Würzburg University Hospital, Pediatric Pneumology, Würzburg, Germany.
  • 21CF Center Hamburg, Hamburg, Germany.
  • 22Greifswald University Hospital, Pneumology/Allergology, Greifswald, Germany.
  • 23Jena University Hospital, Centre for Clinical Studies, Jena, Germany.
  • 24Heidelberg University Hospital, Ear-Nose-Throat Department, Heidelberg, Germany.

Abstract

BACKGROUND:

Chronic rhinosinusitis is a hallmark of Cystic fibrosis (CF) impairing the patients' quality of life and overall health. However, therapeutic options have not been sufficiently evaluated. Bronchial inhalation of mucolytic substances is a gold standard in CF therapy. Previously, we found that sinonasal inhalation of dornase alfa as vibrating aerosol reduces symptoms of chronic rhinosinusitis more effectively than NaCl 0.9% (net treatment benefit: -5.87±2.3 points, p=0.017; SNOT-20 total score). This multicenter study compares the effect of NaCl 6.0% vs. NaCl 0.9% following the protocol from our preceding study with dornase alfa.

METHODS:

Sixty nine CF patients with chronic rhinosinusitis in eleven German CF centers were randomized to receive sinonasal vibrating inhalation of either NaCl 6.0% or NaCl 0.9% for 28days. After 28days of wash-out, patients crossed over to the alternative treatment. The primary outcome parameter was symptom score in the disease-specific quality of life Sino-Nasal Outcome Test-20 (SNOT-20). Additionally, pulmonary function was assessed, as well as rhinomanometry and inflammatory markers in nasal lavage (neutrophil elastase, interleukin (IL)-1β, IL-6, and IL-8) in a subgroup.

RESULTS:

Both therapeutic arms were well tolerated and showed slight improvements in SNOT-20 total scores (NaCl 6.0%: -3.1±6.5 points, NaCl 0.9%: -5.1±8.3 points, ns). In both treatment groups, changes of inflammatory parameters in nasal lavage from day 1 to day 29 were not significant. We suppose that the irritating properties of NaCl 6.0% reduced the suitability of the SNOT-20 scores as an outcome parameter. Alternative primary outcome parameters such as MR-imaging or the quantity of sinonasal secretions mobilized with both saline concentrations were, however, not feasible.

CONCLUSION:

Sinonasal inhalation with NaCl 6.0% did not lead to superior results vs. NaCl 0.9%, whereas dornase alfa had been significantly more effective than NaCl 0.9%.

KEYWORDS:

Hypertonic saline; Inflammation; Nasal lavage; Rhinomanometry; Sino-Nasal Outcome Test-20; Sodium chloride

PMID:
27267518
DOI:
10.1016/j.jcf.2016.05.003
[PubMed - in process]
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