Abstract | BACKGROUND: OBJECTIVES: METHODS: In this double-blind, double-dummy trial, subjects (> or =12 years; N = 981) were randomized to MFNS 200 microg once daily or twice daily for 15 days, amoxicillin 500 mg 3 times daily for 10 days, or respective placebo. Follow-up was 14 days. The primary efficacy endpoint was mean am/pm major symptom score over the treatment phase. Secondary efficacy endpoints included total symptom score. Safety assessments included disease recurrence during follow-up and adverse event monitoring. RESULTS:
Mometasone furoate nasal spray 200 microg twice daily was significantly superior to placebo (P < .001) and amoxicillin (P = .002) at improving major symptom score. Starting on day 2, MFNS 200 microg twice daily improved total symptom score throughout treatment versus amoxicillin (P = .012) and placebo (P < .001). Global response to treatment was significantly greater with MFNS 200 microg twice daily versus amoxicillin (P = .013) and placebo (P = .001). Although significantly superior to placebo, MFNS 200 microg once daily was not superior to amoxicillin for the primary or secondary efficacy endpoints. All treatments were well tolerated with a similar incidence of adverse events. CONCLUSION: In patients with acute, uncomplicated rhinosinusitis, MFNS 200 microg twice daily produced significant symptom improvements versus amoxicillin and placebo, without predisposing the patient to disease recurrence or bacterial infection.
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Authors | Eli O Meltzer, Claus Bachert, Heribert Staudinger |
Journal | The Journal of allergy and clinical immunology
(J Allergy Clin Immunol)
Vol. 116
Issue 6
Pg. 1289-95
(Dec 2005)
ISSN: 0091-6749 [Print] United States |
PMID | 16337461
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Pregnadienediols
- Mometasone Furoate
- Amoxicillin
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Topics |
- Acute Disease
- Administration, Intranasal
- Adolescent
- Adult
- Aged
- Amoxicillin
(adverse effects, therapeutic use)
- Child
- Double-Blind Method
- Female
- Humans
- Male
- Middle Aged
- Mometasone Furoate
- Pregnadienediols
(administration & dosage, adverse effects)
- Rhinitis
(drug therapy)
- Sinusitis
(drug therapy)
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