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The CAFFS Trial: A Randomized Controlled Trial

Rowena J. Dolor, MD, MHS; David L. Witsell, MD, MHS; Anne S. Hellkamp, MS; John W. Williams, Jr, MD, MHS; Robert M. Califf, MD; David L. Simel, MD, MHS; for the Ceftin and Flonase for Sinusitis (CAFFS) Investigators

JAMA. 2001;286:3097-3105.

Context  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.

Design, Setting, and Patients  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).

Intervention  Two puffs (total dose, 200 µg) 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.

Main Outcome Measure  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.

Author Affiliations: Department of Medicine, Durham Veterans Affairs Medical Center and Division of Internal Medicine (Drs Dolor and Simel), Department of Surgery, Durham Veterans Affairs Medical Center and Division of Otolaryngology (Dr Witsell), and Duke Clinical Research Institute (Dr Califf and Ms Hellkamp), Duke University Medical Center, Durham, NC; South Texas Veterans Affairs Health Care System, Audie L. Murphy Division and Division of Internal Medicine, University of Texas Health Science Center, San Antonio (Dr Williams).

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