Document Detail

Intranasal flunisolide spray as an adjunct to oral antibiotic therapy for sinusitis.
MedLine Citation:
PMID:  8258615     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: The diagnosis of sinusitis is difficult and there are few controlled studies of customary therapies. In particular, the possible role of topical intranasal steroid as an adjunct to antibiotic treatment has not been evaluated. METHODS: The study was a multicenter, double-blind, randomized, parallel trial in which patients aged 14 years or older were recruited from allergy practices. All patients had maxillary sinusitis documented by radiographs. Treatment consisted of amoxicillin/clavulanate potassium 500 mg combined with nasal spray of either 100 micrograms flunisolide or placebo to each nostril three times a day for 3 weeks (phase I) followed by administration of flunisolide or placebo nasal spray alone three times a day for 4 weeks (phase II). RESULTS: Clinical symptoms and signs decreased significantly in both treatment groups during phase I (p < 0.01). There was a trend to greater improvement in the patients treated with flunisolide, but only the decrease in turbinate swelling/obstruction was statistically significant at the end of phase I when compared with placebo (p = 0.041). Patients' global assessment of overall effectiveness of treatment was higher for flunisolide than placebo after phase I (p = 0.007) and after phase II (p = 0.08). Maxillary sinus radiographs showed improvement in both treatment groups during phase I (p < 0.004) with somewhat greater regression of abnormal findings in patients treated with flunisolide after phase II (p = 0.066). However, 80% of radiographs were still abnormal at the end of phase I. All types of inflammatory cells were significantly decreased in nasal cytograms in patients treated with flunisolide in comparison with those treated with placebo. Flare-up of sinusitis during phase II occurred in 26% of with those treated with placebo. Flare-up of sinusitis during phase II occurred in 26% of patients treated with flunisolide and 35% of those treated with placebo and tended to be more severe in the latter, although these differences were not statistically significant. Adverse events, mainly gastrointestinal symptoms and headache, were similar in both groups and more frequent in phase I than in phase II, (42 vs 15 patients); these side effects were probably due to the antibiotic. CONCLUSION: The addition of flunisolide topical nasal spray as an adjunct to antibiotic therapy was most effective in global evaluations, tended to improve symptoms, to decrease inflammatory cells in nasal cytograms, to normalize ultrasound scans, and to aid regression of radiographic abnormalities compared with placebo spray.
E O Meltzer; H A Orgel; J W Backhaus; W W Busse; H M Druce; W J Metzger; D Q Mitchell; J C Selner; G G Shapiro; J H Van Bavel
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The Journal of allergy and clinical immunology     Volume:  92     ISSN:  0091-6749     ISO Abbreviation:  J. Allergy Clin. Immunol.     Publication Date:  1993 Dec 
Date Detail:
Created Date:  1994-01-19     Completed Date:  1994-01-19     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  1275002     Medline TA:  J Allergy Clin Immunol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  812-23     Citation Subset:  AIM; IM    
Allergy & Asthma Medical Group & Research Center, A P.C., San Diego, CA 92123.
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MeSH Terms
Administration, Inhalation
Administration, Oral
Administration, Topical
Amoxicillin / administration & dosage*
Amoxicillin-Potassium Clavulanate Combination
Anti-Inflammatory Agents / administration & dosage*
Clavulanic Acids / administration & dosage*
Double-Blind Method
Drug Therapy, Combination / administration & dosage
Fluocinolone Acetonide / administration & dosage,  analogs & derivatives*
Sinusitis / drug therapy*,  radiography
Reg. No./Substance:
0/Anti-Inflammatory Agents; 0/Clavulanic Acids; 26787-78-0/Amoxicillin; 3385-03-3/flunisolide; 67-73-2/Fluocinolone Acetonide; 74469-00-4/Amoxicillin-Potassium Clavulanate Combination

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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