Jochen G Mainz1, Claudia Schien2, Isabella Schiller2, Katja Schädlich2, Assen Koitschev3, Christiane Koitschev4, Joachim Riethmüller5, Uta Graepler-Mainka5, Bärbel Wiedemann6, James F Beck2. 1. Department of Paediatrics, CF-Center, Jena University Hospital, Kochstraße 2, 07745 Jena, Germany. Electronic address: Jochen.Mainz@med.uni-jena.de. 2. Department of Paediatrics, CF-Center, Jena University Hospital, Kochstraße 2, 07745 Jena, Germany. 3. Department of Paediatric Otorhinolaryngology, Olgahospital, Stuttgart, Bismarckstraße 8, 70176 Stuttgart, Germany. 4. Department of Otorhinolaryngology, University Hospital, Tübingen, Elfriede-Aulhorn-Str. 5, 72076 Tübingen, Germany. 5. Department of Paediatrics, University Children's Hospital, Tübingen, Hoppe-Seyler-Str. 1, 72076 Tübingen, Germany. 6. Department of Medical Informatics and Biometrics, Technical University Dresden, Fetscherstr. 74, 01307 Dresden, Germany.
Abstract
BACKGROUND:Chronic rhinosinusitis significantly impairs CF patients' quality of life and overall health. The Pari-Sinus™ device delivers vibrating aerosol effectively to paranasal sinuses. After a small pilot study to assess sinonasal inhalation of dornase alfa and placebo (isotonic saline) on potential sinonasal outcome measures, we present the subsequent prospective double-blind placebo-controlled crossover-trial. METHODS:23 CF patients were randomised to inhale either dornase alfa or isotonic saline for 28 days with the Pari-Sinus™ and after 28 days (wash-out) crossed over to the alternative treatment. The primary outcome parameter was primary nasal symptom score in the disease-specific quality of life Sino-Nasal Outcome-Test-20 (SNOT-20: nasal obstruction/sneezing/runny nose/thick nasal discharge/reduced smelling). RESULTS:Primary nasal symptoms improved significantly with dornase alfa compared with no treatment, while small improvements with isotonic saline did not reach significance. SNOT-20overall scores improved significantly after dornase alfa compared with isotonic saline (p=0.017). Additionally, sinonasal dornase alfa but not isotonic saline significantly improved pulmonary function (FEF75-25: p=0.021). CONCLUSION: Vibrating sinonasal inhalation of dornase alfa reduces rhinosinusitis symptoms in CF.
RCT Entities:
BACKGROUND:Chronic rhinosinusitis significantly impairs CFpatients' quality of life and overall health. The Pari-Sinus™ device delivers vibrating aerosol effectively to paranasal sinuses. After a small pilot study to assess sinonasal inhalation of dornase alfa and placebo (isotonic saline) on potential sinonasal outcome measures, we present the subsequent prospective double-blind placebo-controlled crossover-trial. METHODS: 23 CF patients were randomised to inhale either dornase alfa or isotonic saline for 28 days with the Pari-Sinus™ and after 28 days (wash-out) crossed over to the alternative treatment. The primary outcome parameter was primary nasal symptom score in the disease-specific quality of life Sino-Nasal Outcome-Test-20 (SNOT-20: nasal obstruction/sneezing/runny nose/thick nasal discharge/reduced smelling). RESULTS: Primary nasal symptoms improved significantly with dornase alfa compared with no treatment, while small improvements with isotonic saline did not reach significance. SNOT-20 overall scores improved significantly after dornase alfa compared with isotonic saline (p=0.017). Additionally, sinonasal dornase alfa but not isotonic saline significantly improved pulmonary function (FEF75-25: p=0.021). CONCLUSION: Vibrating sinonasal inhalation of dornase alfa reduces rhinosinusitis symptoms in CF.
Authors: Do-Yeon Cho; Dong-Jin Lim; Calvin Mackey; Christopher G Weeks; Jaime A Peña Garcia; Daniel Skinner; Jessica W Grayson; Harrison S Hill; David K Alexander; Shaoyan Zhang; Bradford A Woodworth Journal: Int Forum Allergy Rhinol Date: 2018-02-07 Impact factor: 3.858