Topical Antibiotic Use In Chronic Rhinosinusitis A Double-Blinded, Randomized, Placebo Controlled Study
Status:
Withdrawn
Trial end date:
2010-01-01
Target enrollment:
Participant gender:
Summary
Chronic rhinosinusitis is a pervasive and costly disease. Recent estimates describe over 20
million Americans suffering from this diagnosis at a cost of over $4.3 billion per year.
Primary intervention consists of oral antibiotics and nasal steroid sprays. A role for
antifungal irrigation has also been proposed. Topical antibiotics are used by some
physicians, but there are few reports in the published literature describing their use and
establishing or refuting their efficacy.
Sykes in 1986 performed a randomized, prospective, double-blinded study with 50 patients
using topical nasal sprays with dexamethasone, tramazoline, and neomycin; dexamethasone and
tramazoline without antimicrobial; and placebo. Both of the treatment groups showed
improvement over placebo, but in those groups there was no significant difference in response
rates between those patients receiving neomycin and those who did not. There were no adverse
events reported. In the same year, Cuenant et al. reported success with neomycin-tixocortol
irrigations in the treatment of chronic rhinosinusitis.
Scheinberg and Otsuji and Vaughn and Carvalho describe their use of various nebulized
antimicrobials (including aminoglycosides) in patients with recurrent sinusitis. Both are
uncontrolled, retrospective studies showing improvement in symptom scores. Neither study
reported any major side effects. Leonard and Bolger describe a case report and review their
success with the use of topical Ceftazidime in 50 patients. Only one patient reported
stinging sensation during administration. They reported no problems with antibiotic
resistance.
Studies by Davidson et al. , and Moss and King describe the use of topical antibiotics for
sinusitis in patients with cystic fibrosis. They report improvement in sinusitis symptoms and
reduction of need for revision sinus surgery in patients treated with surgery followed by
topical intranasal tobramycin. They report no significant side effects.
Dudley described the use of topical gentamicin in a case report of a patient with atrophic
rhinitis. The patient had resolution of her complaints without any adverse symptoms. He also
describes a study by Thornell showing success with streptomycin nasal sprays and reports work
by Rubinstein demonstrating safe administration of gentamicin into the nose without
absorption by the nasal mucosa.
On balance, the literature describes topical antibiotics as a safe, but variably efficacious
treatment for chronic rhinosinusitis. There is a paucity of prospective, randomized, blinded,
and controlled studies. The purpose of this protocol is to describe a scientifically rigorous
study of the use of broad spectrum antibiotic nasal sprays for chronic sinusitis.
The patient population for this study will consist of patients who have a history of multiple
sinus infections each year that require treatment with antibiotics. The patients in this
study will have had recurrent infections despite prior medical and surgical intervention.
They will fulfill the criteria for chronic rhinosinusitis without nasal polyposis.
Treatment will include conventional treatment with oral antibiotics and a topical nasal
steroid. In addition, patients will be randomized to receive either topical antibiotics or a
vehicle placebo. The study will follow patients for a three month period.
Patients will be monitored for improvement in radiographic findings and quality of life when
compared to a randomized and double-blinded placebo group. The patient population identified
for inclusion in this study will also be evaluated for allergy and humoral and innate
immunodeficiency. Nasal lavage will be obtained from the study population and pre and
post-treatment comparisons will be performed.