Sinonasal inhalation of dornase alfa administered by vibrating aerosol to cystic fibrosis patients: a double-blind placebo-controlled cross-over trial

J Cyst Fibros. 2014 Jul;13(4):461-70. doi: 10.1016/j.jcf.2014.02.005. Epub 2014 Mar 1.


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).

Conclusion: Vibrating sinonasal inhalation of dornase alfa reduces rhinosinusitis symptoms in CF.

Trial registration: NCT00534079.

Keywords: Chronic rhinosinusitis; Cystic fibrosis; Dornase alfa; Pari Sinus™; SNOT-20; Sinonasal inhalation.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Intranasal
  • Adolescent
  • Adult
  • Aerosols / administration & dosage
  • Aged
  • Child
  • Cross-Over Studies
  • Cystic Fibrosis / drug therapy*
  • Deoxyribonuclease I / administration & dosage*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Paranasal Sinuses
  • Pilot Projects
  • Prospective Studies
  • Recombinant Proteins / administration & dosage
  • Vibration
  • Young Adult


  • Aerosols
  • Recombinant Proteins
  • Deoxyribonuclease I
  • dornase alfa

Associated data

  • EudraCT/2007-001548-36