Jochen G Mainz1, Ulrike Schumacher2, Katja Schädlich3, Julia Hentschel4, Christiane Koitschev5, Assen Koitschev6, Joachim Riethmüller7, Freerk Prenzel8, Olaf Sommerburg9, Bärbel Wiedemann10, Doris Staab11, Wolfgang Gleiber12, Rainald Fischer13, James F Beck14, Christin Arnold15. 1. Jena University Hospital, CF Centre, Jena, Germany. Electronic address: Jochen.Mainz@med.uni-jena.de. 2. Jena University Hospital, Institute of Medical Statistics and Documentation, Jena, Germany. Electronic address: Ulrike.Schumacher@med.uni-jena.de. 3. Jena University Hospital, CF Centre, Jena, Germany. Electronic address: Katja.Schaedlich@med.uni-jena.de. 4. Jena 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. 5. Klinikum Stuttgart, Pediatric Otorhinolaryngology, Stuttgart, Germany. Electronic address: c.koitschev@klinikum-stuttgart.de. 6. Klinikum Stuttgart, Pediatric Otorhinolaryngology, Stuttgart, Germany. Electronic address: a.koitschev@klinikum-stuttgart.de. 7. Tübingen University Hospital, Pediatric CF Centre, Tübingen, Germany. Electronic address: Joachim.riethmueller@med.uni-tuebingen.de. 8. Leipzig University Hospital, Pediatric Pneumology/Allergy, Leipzig, Germany. Electronic address: freerk.prenzel@uniklinik-leipzig.de. 9. Heidelberg University Hospital, Pediatric CF Centre, Heidelberg, Germany. Electronic address: olaf.sommerburg@med.uni-heidelberg.de. 10. Institute for Medical Informatics and Biometry, Technical University of Dresden, Germany. Electronic address: Baerbel.Wiedemann@tu-dresden.de. 11. Charite' University Hospital Berlin, CF Centre, Berlin, Germany. Electronic address: doris.staab@charite.de. 12. Frankfurt University Hospital, Pneumology/Allergology, Frankfurt, Germany. Electronic address: Wolfgang.Gleiber@kgu.de. 13. München University Hospital, CF Centre, München, Germany. Electronic address: rainald.fischer@gmail.com. 14. Jena University Hospital, CF Centre, Jena, Germany. Electronic address: James.Beck@med.uni-jena.de. 15. Jena University Hospital, CF Centre, Jena, Germany. Electronic address: Christin.Arnold@med.uni-jena.de.
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%. Copyright Â
RCT Entities:
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%. Copyright Â
Authors: Do-Yeon Cho; Shaoyan Zhang; Ahmed Lazrak; Jessica W Grayson; Jaime A Peña Garcia; Daniel F Skinner; Dong Jin Lim; Calvin Mackey; Catherine Banks; Sadis Matalon; Bradford A Woodworth Journal: Int Forum Allergy Rhinol Date: 2018-08-27 Impact factor: 3.858
Authors: P Barski; M Surdacki; A Saj; A Wróblewska; M Ornat; A Pawelak; D Pompa; J Jurgiel; V Ermisch; A Hirnle; I Pirogowicz; I Stanisławska; M Łyp; M Pokorski Journal: Physiol Res Date: 2020-03-27 Impact factor: 1.881