Comparison of cefuroxime with or without intranasal fluticasone for the treatment of rhinosinusitis. The CAFFS Trial: a randomized controlled trial.
BACKGROUND
It is not known whether intranasal corticosteroids are beneficial to treat acute rhinosinusitis in patients with a history of chronic or recurrent sinus symptoms.


OBJECTIVE
To assess whether the addition of an intranasal corticosteroid to antibiotic therapy affects the speed and rate of recovery of such patients with acute rhinosinusitis.


METHODS
A double-blind, randomized, placebo-controlled multicenter trial of 95 patients (median age, 39 years) with a history of recurrent sinusitis or chronic rhinitis and evidence of acute infection by sinus radiograph or nasal endoscopy, which was conducted from October 1998 through April 2000 at 22 sites (12 primary care and 10 otolaryngology).


METHODS
Two puffs (total dose, 200 microgram) of fluticasone propionate (n = 47) or placebo nasal spray (n = 48) in each nostril once daily for 21 days; all received 2 puffs of xylometazoline hydrochloride in each nostril twice daily for 3 days and 250 mg of cefuroxime axetil twice daily for 10 days.


METHODS
Time to clinical success (patient reported cured or much improved) during telephone follow-up at 10, 21, and 56 days.


RESULTS
A total of 88 patients (93%) completed follow-up. Patients recorded their symptoms, work assessment, and compliance during the 3-week treatment phase. Patients receiving fluticasone achieved a significantly higher rate of clinical success than patients receiving placebo (93.5% vs 73.9%; P =.009). Patients treated with fluticasone improved significantly more rapidly (median of 6.0 days to clinical success) vs patients in the placebo group (median of 9.5 days; P =.01).


CONCLUSIONS
The addition of fluticasone to xylometazoline and antimicrobial therapy with cefuroxime improves clinical success rates and accelerates recovery of patients with a history of chronic rhinitis or recurrent sinusitis who present for treatment of acute rhinosinusitis.
Dolor
R J
RJ
Duke Clinical Research Institute, 2400 Pratt St, Durham, NC 27705, USA. dolor001@mc.duke.edu
Witsell
D L
DL
Hellkamp
A S
AS
Williams
J W
JW
Califf
R M
RM
Simel
D L
DL
D000208:Acute Disease; D000281:Administration, Intranasal; D000328:Adult; D000730:Androstadienes / Q000008:administration & dosage / Q000627:therapeutic use*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002444:Cefuroxime / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D002511:Cephalosporins / Q000008:administration & dosage / Q000627:therapeutic use*; D002908:Chronic Disease; D017281:Cost of Illness; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D000068298:Fluticasone; D005938:Glucocorticoids / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D014663:Nasal Decongestants / Q000008:administration & dosage / Q000627:therapeutic use; D016016:Proportional Hazards Models; D011788:Quality of Life; D012220:Rhinitis / Q000188:drug therapy*; D012852:Sinusitis / Q000188:drug therapy*
D000730:Androstadienes; D000893:Anti-Inflammatory Agents; D002511:Cephalosporins; D005938:Glucocorticoids; D007093:Imidazoles; D014663:Nasal Decongestants; D000068298:Fluticasone; D002444:Cefuroxime; C009695:xylometazoline; C040738:cefuroxime axetil