title: Sinonasal inhalation of dornase alfa administered by vibrating aerosol to cystic fibrosis patients: a double-blind placebo-controlled cross-over trial.
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-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).
  
  
  CONCLUSIONS
  Vibrating sinonasal inhalation of dornase alfa reduces rhinosinusitis symptoms in CF.
authors.affiliation: Department of Paediatrics, CF-Center, Jena University Hospital, Kochstraße 2, 07745 Jena, Germany. Electronic address: Jochen.Mainz@med.uni-jena.de.
authors.forename: Jochen G
authors.initials: JG
authors.lastname: Mainz
authors.affiliation: Department of Paediatrics, CF-Center, Jena University Hospital, Kochstraße 2, 07745 Jena, Germany.
authors.forename: Claudia
authors.initials: C
authors.lastname: Schien
authors.affiliation: Department of Paediatrics, CF-Center, Jena University Hospital, Kochstraße 2, 07745 Jena, Germany.
authors.forename: Isabella
authors.initials: I
authors.lastname: Schiller
authors.affiliation: Department of Paediatrics, CF-Center, Jena University Hospital, Kochstraße 2, 07745 Jena, Germany.
authors.forename: Katja
authors.initials: K
authors.lastname: Schädlich
authors.affiliation: Department of Paediatric Otorhinolaryngology, Olgahospital, Stuttgart, Bismarckstraße 8, 70176 Stuttgart, Germany.
authors.forename: Assen
authors.initials: A
authors.lastname: Koitschev
authors.affiliation: Department of Otorhinolaryngology, University Hospital, Tübingen, Elfriede-Aulhorn-Str. 5, 72076 Tübingen, Germany.
authors.forename: Christiane
authors.initials: C
authors.lastname: Koitschev
authors.affiliation: Department of Paediatrics, University Children's Hospital, Tübingen, Hoppe-Seyler-Str. 1, 72076 Tübingen, Germany.
authors.forename: Joachim
authors.initials: J
authors.lastname: Riethmüller
authors.affiliation: Department of Paediatrics, University Children's Hospital, Tübingen, Hoppe-Seyler-Str. 1, 72076 Tübingen, Germany.
authors.forename: Uta
authors.initials: U
authors.lastname: Graepler-Mainka
authors.affiliation: Department of Medical Informatics and Biometrics, Technical University Dresden, Fetscherstr. 74, 01307 Dresden, Germany.
authors.forename: Bärbel
authors.initials: B
authors.lastname: Wiedemann
authors.affiliation: Department of Paediatrics, CF-Center, Jena University Hospital, Kochstraße 2, 07745 Jena, Germany.
authors.forename: James F
authors.initials: JF
authors.lastname: Beck
mesh_terms: D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000336:Aerosols / Q000008:administration & dosage; D000368:Aged; D002648:Child; D018592:Cross-Over Studies; D003550:Cystic Fibrosis / Q000188:drug therapy*; D003850:Deoxyribonuclease I / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010256:Paranasal Sinuses; D010865:Pilot Projects; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage; D014732:Vibration; D055815:Young Adult
chemical_list: D000336:Aerosols; D011994:Recombinant Proteins; D003850:Deoxyribonuclease I; C568813:dornase alfa
keywords: Chronic rhinosinusitis; Cystic fibrosis; Dornase alfa; Pari Sinus™; SNOT-20; Sinonasal inhalation