A single topical agent is clinically equivalent to the combination of topical and oral antibiotic treatment for otitis externa

Roland, Peter S.; Belcher, Barbara P.; Bettis, Robert; Makabale, Reynaldo L.; Conroy, Peter J.; Wall, G. Michael; Dupre, Sheryl; Potts, Susan; Hogg, Gail; Weber, Kaye; The Cipro HC Study Group,

doi:10.1016/j.amjoto.2007.09.002

« Previous Next »American Journal of Otolaryngology - Head and Neck Medicine and Surgery
Volume 29, Issue 4 , Pages 255-261, July 2008

A single topical agent is clinically equivalent to the combination of topical and oral antibiotic treatment for otitis externa☆

Peter S. Roland, MD
- Department of Otolaryngology Head-Neck Surgery, University of Texas, Southwestern Medical School, Dallas TX, USA.
- Corresponding author. Department of Otolaryngology Head-Neck Surgery, University of Texas, Southwestern Medical School, Dallas TX 75235-9035, USA.
Barbara P. Belcher, MD
- Protocare Trials, San Antonio Center for Clinical Research and Child Care Associates, San Antonio TX, USA
Robert Bettis, MD
- Family Medicine, University of Washington, Edmonds WA, USA
Reynaldo L. Makabale, MD
- General Pediatrics, Los Angeles CA, USA
Peter J. Conroy, PhD JD
- Otic/Nasal Products Development, Alcon Research, Ltd, Fort Worth TX, USA
G. Michael Wall, PhD
- Otic/Nasal Products Development, Alcon Research, Ltd, Fort Worth TX, USA
Sheryl Dupre, BS
- Otic/Nasal Products Development, Alcon Research, Ltd, Fort Worth TX, USA
Susan Potts, MS
- Otic/Nasal Products Development, Alcon Research, Ltd, Fort Worth TX, USA
Gail Hogg, BS
- Otic/Nasal Products Development, Alcon Research, Ltd, Fort Worth TX, USA
Kaye Weber, MS
- Department of Otolaryngology Head-Neck Surgery, University of Texas, Southwestern Medical School, Dallas TX, USA.
The Cipro HC Study Group

Received 9 May 2007 published online 20 March 2008.

Abstract

Objective

To demonstrate clinical equivalence (statistical noninferiority) of topical ciprofloxacin and hydrocortisone (CHC, Cipro HC) and topical neomycin/polymyxin b/hydrocortisone (NPH, Cortisporin) with systemic amoxicillin (AMX, Amoxil), for treatment of acute otitis externa (AOE).

Design

Randomized, active-control, observer-blind, multicenter trial.

Patients

Altogether, 206 patients were enrolled (CHC, 106; NPH + AMX, 100). Patients were ≥1 year of age, had AOE >2 days with at least mild symptoms, and gave informed consent. All were evaluable for safety, and 151 were evaluable for efficacy.

Interventions

Ciprofloxacin and hydrocortisone 3 drops twice daily for 7 days (adults and children) or NPH 4 drops (adults) or 2 drops (children) with AMX 250 mg (adults and children) 3 times daily for 10 days, as directed in approved product labeling.

Main Outcome Measures

The primary efficacy variable was response to therapy 7 days after treatment ended (test of cure). Secondary variables included time to end of pain, symptom scores (otalgia and tenderness) and microbiological eradication. Noninferiority was declared if the lower confidence limit around the measurement difference was above −10 (nearer zero).

Results

Response to therapy was higher for CHC (95.71% vs 89.83%) but was statistically noninferior (lower confidence limit, −4.98) to NPH + AMX. Median time to end of pain was 6 days for both groups. Noninferiority was declared for symptom scores at all measurement periods and for microbiological eradication. No serious adverse events related to treatment were reported.

Conclusions

Ciprofloxacin and hydrocortisone is clinically equivalent to NPH + AMX for the treatment of AOE in adults and children. However, low systemic exposure, absence of ototoxicity, and less frequent dosing clearly favor Cipro HC.