title: The value of a feasibility study into long-term macrolide therapy in chronic rhinosinusitis.
abstract: OBJECTIVE
  There is currently conflicting level 1 evidence in the use of long-term antibiotics for chronic rhinosinusitis without nasal polyps. The primary aim of this feasibility study was to optimise future randomised trial design by assessing recruitment and retention of patients alongside providing preliminary data on symptomatic control.
  
  
  METHODS
  Prospective, multicentre feasibility (cohort) study with all patients receiving macrolide therapy for 12 weeks and a further subsequent 12-week follow-up. Participants received a 12-week course of clarithromycin 250 mg alongside twice daily topical mometasone and nasal douching. Primary outcomes focused on recruitment, retention and compliance. Clinical and quality-of-life outcomes measures were also recorded.
  
  
  METHODS
  Patients were prospectively recruited from six UK outpatient clinics.
  
  
  METHODS
  Adult patients with chronic rhinosinusitis without nasal polyps and no prior endoscopic sinus surgery underwent baseline assessment and then follow-up at 3 and 6 months.
  
  
  METHODS
  Six-month recruitment and retention data.
  
  
  RESULTS
  Over 13 months, 55 adults were recruited from five centres. Four patients declined participation. 75% of patients were retained within the study. Dropouts included one medication contraindication, three unable to tolerate medication and 10 not attending full follow-up. Sino Nasal Outcome Test-22 and endoscopic scores showed statistically significant improvement. No other clinical or quality-of-life assessment improvements were seen.
  
  
  CONCLUSIONS
  Retention and recruitment to a trial using long-term clarithromycin to treat chronic rhinosinusitis without nasal polyps is achievable and this data will support a future randomised controlled trial. The study provides vital insight into trial design, thus informing UK research networks and rhinology researchers internationally.
authors.affiliation: James Paget University Hospital, Great Yarmouth, UK.
authors.forename: J
authors.initials: J
authors.lastname: Bewick
authors.affiliation: Queen Elizabeth Hospital, Birmingham, UK.
authors.forename: S
authors.initials: S
authors.lastname: Ahmed
authors.affiliation: Freeman Hospital, Newcastle, UK.
authors.forename: S
authors.initials: S
authors.lastname: Carrie
authors.affiliation: Guys & St Thomas' Hospital, London, UK.
authors.forename: C
authors.initials: C
authors.lastname: Hopkins
authors.affiliation: Queens Medical Centre, Nottingham, UK.
authors.forename: A
authors.initials: A
authors.lastname: Sama
authors.affiliation: Royal Surrey County Hospital, Guildford, UK.
authors.forename: V
authors.initials: V
authors.lastname: Sunkaraneni
authors.affiliation: James Paget University Hospital, Great Yarmouth, UK.
authors.forename: J
authors.initials: J
authors.lastname: Woods
authors.affiliation: University College London, London, UK.
authors.forename: S
authors.initials: S
authors.lastname: Morris
authors.affiliation: Norwich Medical School, University of East Anglia, Norwich, UK.
authors.forename: S
authors.initials: S
authors.lastname: Erskine
authors.affiliation: James Paget University Hospital, Great Yarmouth, UK.|Norwich Medical School, University of East Anglia, Norwich, UK.
authors.forename: C M
authors.identifier: http://orcid.org/0000-0002-1125-3236
authors.initials: CM
authors.lastname: Philpott
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D002908:Chronic Disease; D017291:Clarithromycin / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D000068656:Mometasone Furoate / Q000627:therapeutic use; D018579:Patient Selection; D011446:Prospective Studies; D012220:Rhinitis / Q000188:drug therapy*; D012852:Sinusitis / Q000188:drug therapy*; D007507:Therapeutic Irrigation; D006113:United Kingdom; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D000893:Anti-Inflammatory Agents; D000068656:Mometasone Furoate; D017291:Clarithromycin