Mometasone Furoate Nasal Spray for the Treatment of Nasal Polyposis
Mometasone Furoate Nasal Spray for the Treatment of Nasal Polyposis
Published: October 2008
Nasal polyposis is a chronic inflammatory disease of the nasal and paranasal sinus mucosa that occurs in up to 4% of the general population and a much higher proportion of patients with conditions such as aspirin intolerance, asthma or cystic fibrosis. The exact cause and underlying mechanisms of nasal polyposis are not well understood, but chronic inflammation is a major factor as indicated by the increased presence of inflammatory cells, such as eosinophils, in the nasal polyps.
The symptoms of nasal polyposis, especially congestion/obstruction and loss of sense of smell, can have a substantial impact on patients’ quality of life (QoL). Currently, intranasal corticosteroids, including mometasone furoate, are the recommended first-line treatment for mild to moderate nasal polyposis. The benefit of mometasone furoate nasal spray (MFNS) in polyposis has been verified by three large phase III studies, which included almost 1,000 patients. Improvements were seen in all parameters put in relation to the disease.
Aetiological Factors and Epidemiology
Nasal polyposis is often associated with chronic rhinosinusitis (CRS). In the recent European Position Paper on Rhinosinusitis and Nasal Polyps, nasal polyposis is considered to be a subgroup of CRS.1 The aetiology of nasal polyposis remains unclear; however, there is a clear association with systemic diseases such as asthma and cystic fibrosis as well as intolerance to aspirin. The reported prevalence of nasal polyposis ranges from 2.1% to 4.3% of the general population in European countries.2-4 Nasal polyposis usually develops in adulthood and its incidence increases with age; it also occurs more frequently in males than in females.5 Nasal polyposis is rare in children unless associated with cystic fibrosis, which is a disease dominated by neutrophil infiltration.5
Treatment of Nasal Polyposis
The objectives of the management of nasal polyposis are antiinflammatory – i.e., to reduce or eliminate polyps – open the nasal airway, improve or restore the sense of smell, prevent polyp recurrence and improve patient QoL.6,7 Regular treatment with intranasal corticosteroids is traditionally considered the medical therapy of choice in mild or moderate nasal polyposis, with surgery reserved for more severe cases.1,8 The cell infiltration with eosinohils, neutrophils and T cells indicates the necessity of anti-inflammatory treatment of changes in the adjacent nasal mucosa in combination with surgery.9
Guidelines on the management of nasal polyposis recommend that surgery to remove nasal polyps should be undertaken only in patients with very large polyps or in those who have failed to respond to corticosteroid therapy.1,10 However, the evidence for this is minute and studies with early surgical intervention are lacking. The addition of endoscopic nasal surgery to a combination of oral and nasal corticosteroid treatment has a clear-cut effect on nasal polyp size, but a limited effect on perceived nasal obstruction and other symptoms.11 Moreover, polyp recurrence rates after endoscopic sinus surgery can be as high as 60%, especially in asthmatic patients or those with aspirin intolerance.5,12,13 Therefore, it may be more appropriate to consider surgery as an anti-inflammatory treatment in those cases.
MFNS
Currently, no definite cure for nasal polyposis is available, but local corticosteriods are recommended as a basic symptomatic treatment. By reducing inflammation they may reduce polyp size, prevent new polyp formation and delay, or potentially prevent, the need for surgery, although most patients with nasal polyposis may eventually require surgery.7,14 MFNS (Nasonex®, Schering-Plough Corporation) is a potent intranasal synthetic corticosteroid that is approved for the treatment of nasal polyps in 15 European countries and in the US. It is indicated for the treatment in patients aged 18 years and older.15 The usual recommended starting dose of MFNS for nasal polyposis in many countries is a once-daily dose (QD) of 200μg that may be increased to twice-daily (BID) if symptoms are inadequately controlled after five to six weeks.
Other indications include prophylaxis and treatment of allergic rhinitis, treatment of non-allergic rhinitis and acute rhinosinusitis in adults.
Clinical Studies with MFNS
The efficacy and safety of MNFS for the treatment of nasal polyps in subjects aged 18 years and older have been demonstrated in phase III clinical studies of four months’ duration. A total of 962 patients with bilateral nasal polyps and clinically significant congestion/obstruction were included for treatment in three studies. Two of the studies were similar large-scale, multicentre, randomised, double-blind, placebocontrolled studies involving a total of 664 adults.16,17 Subjects were randomly assigned in a 1:1:1 ratio to treatment with MFNS 200μg QD, MFNS 200μg BID or placebo. The third trial, conducted at 12 centres in four Nordic countries (Denmark, Finland, Norway, Sweden), included 298 subjects randomly assigned to receive either MFNS 200μg or placebo.18
- Fokkens W, Lund V, Bachert C, et al., EACCI European Position Paper on Rhinosinusitis and Nasal Polyps, Rhinol Suppl, 2005;18:1–87.
- Hedman J, Kaprio J, Poussa T, Nieminen MM, Prevalence of asthma, aspirin intolerance, nasal polyposis and chronic obstructive pulmonary disease in a population-based study, Int J Epidemiol, 1999;28:717–22.
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- Dalziel K, Stein K, Round A, et al., Systematic review of endoscopic sinus surgery for nasal polyps, Health Technol Assess, 2003;7:1–159.
- Mygind N, Advances in the medical treatment of nasal polyps, Allergy, 1999;54(Suppl.53):12–16.
- Tuncer U, Soylu L, Aydogan B, et al., The effectiveness of steroid treatment in nasal polyposis, Auris Nasus Larynx, 2003;30:263–8.
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- Blomqvist EH, Lundblad L, Anggard A, et al., A randomized controlled study evaluating medical treatment versus surgical treatment in addition to medical treatment of nasal polyposis, J Allergy Clin Immunol, 2001;107:224–8.
- Albu S, Tomescu E, Mexca Z, et al., Recurrence rates in endonasal surgery for polyposis, Acta Otorhinolaryngol Belg, 2004;58:79–86.
- Wynn R, Har-El G, Recurrence rates after endoscopic sinus surgery for massive sinus polyposis, Laryngoscope, 2004;114:811–13.
- Burgel PR, Cardell LO, Ueki IF, Nadel JA, Intranasal steroids decrease eosinophils but not mucin expression in nasal polyps, Eur Respir J, 2004;24:594–600.
- NASONEX® (mometasone furoate monohydrate) Nasal Spray, 50 mcg, product information, Schering Corporation, Kenilworth, NJ, 07033, USA, 2005.
- Small CB, Hernandez J, Reyes A, et al., Efficacy and safety of mometasone furoate nasal spray in nasal polyposis, J Allergy Clin Immunol, 2005;116:1275–81.
- Stjärne P, Mosges R, Jorissen M, et al., A randomized controlled trial of mometasone furoate nasal spray for the treatment of nasal polyposis, Arch Otolaryngol Head Neck Surg, 2006;132:179–85.
- Stjärne P, Blomgren K, Caye-Thomasen P, et al., The efficacy and safety of once-daily mometasone furoate in patients with nasal polyposis, Acta Otolaryngol, 2006;126:606–12.
- Mygind N, Lildholt T, Nasal polyps: epidemiology, pathogenesis and treatment, in: Settipane GA, Lund V (eds), Medical Management, Providence (RI): Oceanside Publications Inc., 1997:147–55.
- Ruhno J, Andersson B, Denburg J, et al., A double-blind comparison of intranasal budesonide with placebo for nasal polyposis, J Allergy Clin Immunol, 1990;86:946–53.
- Jankowski R, Schrewelius C, Bonfils P, et al., Efficacy and tolerability of budesonide aqueous nasal spray treatment in patients with nasal polyps, Arch Otolaryngol Head Neck Surg, 2001;127:447–52.
- Penttila M, Poulsen P, Hollingworth K, Holmstrom M, Doserelated efficacy and tolerability of fluticasone propionate nasal drops 400μg once daily and twice daily in the treatment of bilateral nasal polyposis: a placebo-controlled randomized study in adult patients, Clin Exp Allergy, 2000;30:94–102.
- Keith P, Nieminen J, Hollingworth K, Dolovich J, Efficacy and tolerability of fluticasone propionate nasal drops 400 microgram once daily compared with placebo for the treatment of bilateral polyposis in adults, Clin Exp Allergy, 2000;30:1460–68.
- Radenne F, Lamblin C, Vandezande L-M, et al., Quality of life in nasal polyposis, J Allergy Clin Immunol, 1999;103:79–84.
- Deems DA, Doty RL, Settle RG, et al., Smell and taste disorders, a study of 750 patients from the University of Pennsylvania Smell and Taste Center, Arch Otolaryngol Head Neck Surg, 1991;117:519–28.
- Serrano E, Neukirch F, Pribil C, et al., Nasal polyposis in France: impact on sleep and quality of life, J Laryngol Otol, 2005;119:543–9.
- Boner AL, Effects of intranasal corticosteroids on the hypothalamic-pituatary-adrenal axis in children, J Allergy Clin Immunol, 2001;108:32–9.
- Derendorf H, Daley-Yates PT, Pierre LN, Efthimou J, Bioavailability and metabolism of mometasone furoate:pharmacology versus methodology, J Clin Pharmacol, 2002;42:383–7.
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- 26 March 2010
- 7 April 2010







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