Rhinitis, sinusitis, and ocular diseases
Treating acute rhinosinusitis: Comparing efficacy and safety of mometasone furoate nasal spray, amoxicillin, and placebo

https://doi.org/10.1016/j.jaci.2005.08.044Get rights and content

Background

Intranasal corticosteroids used with antibiotics are known to improve rhinosinusitis symptoms compared with antibiotic therapy alone. However, the efficacy of intranasal corticosteroid monotherapy for acute, uncomplicated rhinosinusitis is not established.

Objectives

To evaluate efficacy and safety of mometasone furoate nasal spray (MFNS) versus amoxicillin and placebo in patients with acute, uncomplicated rhinosinusitis.

Methods

In this double-blind, double-dummy trial, subjects (≥12 years; N = 981) were randomized to MFNS 200 μg 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 μg twice daily was significantly superior to placebo (P < .001) and amoxicillin (P = .002) at improving major symptom score. Starting on day 2, MFNS 200 μg 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 μg twice daily versus amoxicillin (P = .013) and placebo (P = .001). Although significantly superior to placebo, MFNS 200 μg 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 μg twice daily produced significant symptom improvements versus amoxicillin and placebo, without predisposing the patient to disease recurrence or bacterial infection.

Section snippets

Study design

This randomized, double-blind, double-dummy, placebo-controlled study was conducted at 71 medical centers in 14 countries from January to September 2003. The study compared the efficacy and safety of MFNS 200 μg once daily with MFNS 200 μg twice daily to establish the minimally effective MFNS dose.

The study was conducted in accordance with the Declaration of Helsinki and guidelines on Good Clinical Practice. Subjects who were eligible at the screening visit (visit 1) and baseline visit (visit

Subject disposition and characteristics

A total of 981 subjects were randomized to treatment. Each subject received at least 1 dose of study drug and was included in the efficacy and safety analyses. There were no clinically relevant differences in demographic characteristics between the treatment groups, and baseline symptom data were comparable (Table I). Mean MSS at baseline was 8.17 to 8.53 across the 4 treatment groups, indicating that most subjects had mild-to-moderate disease. Less than 22% and 29% of subjects had a history of

Discussion

It has been shown that acute rhinosinusitis frequently resolves without medical intervention. This is most likely a result of the underlying viral and/or bacterial pathology of acute rhinosinusitis. Nevertheless, considering the host of symptoms associated with acute rhinosinusitis, recovery can take time and be of substantial discomfort to the affected patient. Although antibiotics have been the mainstay of therapy,20, 21 recent evidence has suggested that intranasal corticosteroids can

References (25)

  • S.D. de Ferranti et al.

    Are amoxycillin and folate inhibitors as effective as other antibiotics for acute sinusitis? a meta-analysis

    BMJ

    (1998)
  • W. Stalman et al.

    The end of antibiotic treatment in adults with acute sinusitis-like complaints in general practice? a placebo-controlled double-blind randomized doxycycline trial

    Br J Gen Pract

    (1997)
  • Cited by (188)

    • A Pragmatic Approach Towards Sinonasal Diseases

      2020, Journal of Allergy and Clinical Immunology: In Practice
    View all citing articles on Scopus

    Disclosure of potential conflict of interest: E. Meltzer received grant support from Schering-Plough for this study and is a consultant on the speakers' bureau and has received grants from numerous pharmaceutical companies. H. Staudinger and C. Bachert have disclosed no conflict of interest.

    Supported by a grant from the Schering-Plough Research Institute.

    View full text