title: Efficacy and tolerability of a new nasal spray formulation containing hyaluronate and tobramycin in cystic fibrosis patients with bacterial rhinosinusitis.
abstract: BACKGROUND
  Chronic rhinosinusitis is common in cystic fibrosis (CF), as CFTR defects equally affect the airway and sinonasal mucosa. However, therapeutic strategies for CF-associated chronic rhinosinusitis lag behind current approaches for pulmonary disease.
  
  
  OBJECTIVE
  To assess the tolerability and efficacy of a nasal spray formulation containing 0.2% sodium hyaluronate and 3% tobramycin compared to a control formulation containing 0.2% sodium hyaluronate alone in the treatment of bacterial rhinosinusitis in patients with CF.
  
  
  METHODS
  In a double-blind controlled study, 27 patients with an established diagnosis of CF and a documented nasal infection with Pseudomonas aeruginosa and/or Staphylococcus aureus [22 males (81%), median age of 15 years (range 5-26 yrs)], were randomized to receive the nasal spray formulation containing hyaluronate and tobramycin (N=14) or hyaluronate alone (N=13) for 14 days. Efficacy and local tolerability of the treatments were assessed by ear, nose and throat (ENT) examination and related symptoms.
  
  
  RESULTS
  The formulation containing hyaluronate and tobramycin was more effective than hyaluronate alone in improving the status of the nasal mucosa, in reducing the mucopurulent secretion at the level of the osteomeatal complex and in improving ENT symptoms (hyposmia/anosmia and headache/facial pain). The treatment was well tolerated without relevant side effects.
  
  
  CONCLUSIONS
  The present study suggests that the combination therapy with hyaluronate plus tobramycin was more effective than hyaluronate alone in the treatment of bacterial rhinosinusitis in CF.
  
  
  BACKGROUND
  EudraCT 2007-003628-39.
authors.affiliation: ENT Department, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milano, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Di Cicco
authors.affiliation: Cystic Fibrosis Center, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milano, Italy.
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Alicandro
authors.affiliation: Cystic Fibrosis Center, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milano, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Claut
authors.affiliation: Cystic Fibrosis Microbiology Laboratory, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milano, Italy.
authors.forename: Lisa
authors.initials: L
authors.lastname: Cariani
authors.affiliation: ENT Department, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milano, Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Luca
authors.affiliation: Cystic Fibrosis Microbiology Laboratory, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milano, Italy.
authors.forename: Gloria
authors.initials: G
authors.lastname: Defilippi
authors.affiliation: Cystic Fibrosis Center, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milano, Italy.
authors.forename: Diana
authors.initials: D
authors.lastname: Costantini
authors.affiliation: Cystic Fibrosis Center, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milano, Italy. Electronic address: carla.colombo@unimi.it.
authors.forename: Carla
authors.initials: C
authors.lastname: Colombo
mesh_terms: D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D001419:Bacteria / Q000302:isolation & purification; D001424:Bacterial Infections / Q000150:complications / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D003550:Cystic Fibrosis / Q000150:complications* / Q000188:drug therapy; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage*; D008297:Male; D009297:Nasal Mucosa / Q000382:microbiology; D059085:Nasal Sprays; D010865:Pilot Projects; D012220:Rhinitis / Q000150:complications / Q000188:drug therapy* / Q000382:microbiology; D012852:Sinusitis / Q000150:complications / Q000188:drug therapy* / Q000382:microbiology; D014031:Tobramycin / Q000008:administration & dosage*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D004338:Drug Combinations; D059085:Nasal Sprays; D006820:Hyaluronic Acid; D014031:Tobramycin
keywords: Bacterial rhinosinusitis; Cystic fibrosis; Hyaluronic acid; Nasal spray formulation; Tobramycin