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Expert Opinion on Drug Safety Volume 15, 2016 - Issue 1
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Drug Safety Evaluations

Safety evaluation of MP29-02 (a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate) for allergic rhinitis

Ludger KlimekDepartment of Otorhinolaryngology, Zentrum für Rhinologie und Allergologie, An den Quellen 10 D-65183, Wiesbaden, GermanyCorrespondence[email protected]
,
Jean BousquetDepartment of Pneumology, University of Montpellier – Hopital Arnaud de Villeneuve, Montpellier, France
&
David PriceGeneral Practice Airways Group Professor of Primary Care Respiratory Medicine, Department of General Practice and Primary Care, Foresterhill Health Centre, University of Aberdeen, Westburn Road, AberdeenAB25 2AY, UK
Pages 117-129 | Published online: 23 Dec 2015

Bibliography

  • Papers of special note have been highlighted as either of interest (•) or of considerable interest (••) to readers.
  • Bousquet J, Khaltaev N, Cruz AA, et al. Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA(2)LEN and AllerGen). Allergy. 2008;63(Suppl 86):8–160.
  • Kim JL, Brisman J, Aberg MA, et al. Trends in the prevalence of asthma, rhinitis, and eczema in 15 year old adolescents over an 8 year period. Respir Med. 2014;108:701–708.
  • Bjerg A, Ekerljung L, Middelveld R, et al. Increased prevalence of symptoms of rhinitis but not of asthma between 1990 and 2008 in Swedish adults: comparisons of the ECRHS and GA(2)LEN surveys. PLoS One. 2011;6:e16082.
  • Hakansson K, Thomsen SF, Ulrik CS, et al. Increase in the prevalence of rhinitis among Danish children from 1986 to 2001. Pediatr Allergy Immunol. 2007;18:154–159.
  • de MR, Cappa V, Accordini S, et al. Trends in the prevalence of asthma and allergic rhinitis in Italy between 1991 and 2010. Eur Respir J. 2012;39:883–892.
  • Duksal F, Akcay A, Becerir T, et al. Rising trend of allergic rhinitis prevalence among Turkish schoolchildren. Int J Pediatr Otorhinolaryngol. 2013;77:1434–1439.
  • Fuertes E, Butland BK, Ross AH, et al. Childhood intermittent and persistent rhinitis prevalence and climate and vegetation: a global ecologic analysis. Ann Allergy Asthma Immunol. 2014;113:386–392.
  • Pashley CH, Satchwell J, Edwards RE. Ragweed pollen: is climate change creating a new aeroallergen problem in the UK? Clin Exp Allergy. 2015;45:1262–1265.
  • Silverberg JI, Braunstein M, Lee-Wong M. Association between climate factors, pollen counts, and childhood hay fever prevalence in the United States. J Allergy Clin Immunol. 2015;135:463–469.
  • Maurer M, Zuberbier T. Undertreatment of rhinitis symptoms in Europe: findings from a cross-sectional questionnaire survey. Allergy. 2007;62:1057–1063.
  • Meltzer EO. Allergic rhinitis: the impact of discordant perspectives of patient and physician on treatment decisions. Clin Ther. 2007;29:1428–1440.
  • Small M, Piercy J, Demoly P, et al. Burden of illness and quality of life in patients being treated for seasonal allergic rhinitis: a cohort survey. Clin Transl Allergy. 2013;3:33.
  • Bousquet PJ, Demoly P, Devillier P, et al. Impact of allergic rhinitis symptoms on quality of life in primary care. Int Arch Allergy Immunol. 2013;160:393–400.
  • Mullol J. A survey of the burden of allergic rhinitis in Spain. J Investig Allergol Clin Immunol. 2009;19:27–34.
  • Valovirta E, Myrseth SE, Palkonen S. The voice of the patients: allergic rhinitis is not a trivial disease. Curr Opin Allergy Clin Immunol. 2008;8:1–9.
  • Accordini S, Corsico AG, Calciano L, et al. The impact of asthma, chronic bronchitis and allergic rhinitis on all-cause hospitalizations and limitations in daily activities: a population-based observational study. BMC Pulm Med. 2015;15:10.
  • Bhattacharyya N. Functional limitations and workdays lost associated with chronic rhinosinusitis and allergic rhinitis. Am J Rhinol Allergy. 2012;26:120–122.
  • Fang BJ, Tonelli LH, Soriano JJ, et al. Disturbed sleep: linking allergic rhinitis, mood and suicidal behavior. Front Biosci (Schol Ed). 2010;2:30–46.
  • Sansone RA, Sansone LA. Allergic rhinitis: relationships with anxiety and mood syndromes. Innov Clin Neurosci. 2011;8:12–17.
  • Braido F, Baiardini I, Scichilone N, et al. Illness perception, mood and coping strategies in allergic rhinitis: are there differences among ARIA classes of severity? Rhinology. 2014;52:66–71.
  • Benninger MS, Benninger RM. The impact of allergic rhinitis on sexual activity, sleep, and fatigue. Allergy Asthma Proc. 2009;30:358–365.
  • Colas C, Galera H, Anibarro B, et al. Disease severity impairs sleep quality in allergic rhinitis (The SOMNIAAR study). Clin Exp Allergy. 2012;42:1080–1087.
  • Leger D, Annesi-Maesano I, Carat F, et al. Allergic rhinitis and its consequences on quality of sleep: an unexplored area. Arch Intern Med. 2006;166:1744–1748.
  • Kremer B, den Hartog HM, Jolles J. Relationship between allergic rhinitis, disturbed cognitive functions and psychological well-being. Clin Exp Allergy. 2002;32:1310–1315.
  • Walker S, Khan-Wasti S, Fletcher M, et al. Seasonal allergic rhinitis is associated with a detrimental effect on examination performance in United Kingdom teenagers: case-control study. J Allergy Clin Immunol. 2007;120:381–387.
  • Vuurman EF, Vuurman LL, Lutgens I, et al. Allergic rhinitis is a risk factor for traffic safety. Allergy. 2014;69:906–912.
  • Hellgren J, Cervin A, Nordling S, et al. Allergic rhinitis and the common cold–high cost to society. Allergy. 2010;65:776–783.
  • Lamb CE, Ratner PH, Johnson CE, et al. Economic impact of workplace productivity losses due to allergic rhinitis compared with select medical conditions in the United States from an employer perspective. Curr Med Res Opin. 2006;22:1203–1210.
  • Zuberbier T, Lotvall J, Simoens S, et al. Economic burden of inadequate management of allergic diseases in the European Union: a GA(2) LEN review. Allergy. 2014;69:1275–1279.
  • Pitman R, Paracha N, Parker C, et al. Episode pattern and healthcare utilisation in patients with seasonal allergic rhinitis. Allergy. 2012;67:A885.
  • Bousquet PJ, Bachert C, Canonica GW, et al. Uncontrolled allergic rhinitis during treatment and its impact on quality of life: a cluster randomized trial. J Allergy Clin Immunol. 2010;126:666–668.
  • Brozek JL, Bousquet J, Baena-Cagnani CE, et al. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 revision. J Allergy Clin Immunol. 2010;126:466–476.
  • Scadding GK, Durham SR, Mirakian R, et al. BSACI guidelines for the management of allergic and non-allergic rhinitis. Clin Exp Allergy. 2008;38:19–42.
  • Wallace DV, Dykewicz MS, Bernstein DI, et al. The diagnosis and management of rhinitis: an updated practice parameter. J Allergy Clin Immunol. 2008;122:S1–S84.
  • Hellings PW, Dobbels F, Denhaerynck K, et al. Explorative study on patient’s perceived knowledge level, expectations, preferences and fear of side effects for treatment for allergic rhinitis. Clin Transl Allergy. 2012;2:9.
  • Ciprandi G, Incorvaia C, Scurati S, et al. Patient-related factors in rhinitis and asthma: the satisfaction with allergy treatment survey. Curr Med Res Opin. 2011;27:1005–1011.
  • Meltzer EO, Blaiss MS, Derebery MJ, et al. Burden of allergic rhinitis: results from the Pediatric Allergies in America survey. J Allergy Clin Immunol. 2009;124:S43–S70.
  • Nathan RA. The burden of allergic rhinitis. Allergy Asthma Proc. 2007;28:3–9.
  • Naclerio RM, Hadley JA, Stoloff S, et al. Patient and physician perspectives on the attributes of nasal allergy medications. Allergy Asthma Proc. 2007;28(Suppl 1):S11–S117.
  • Price D, Bousquet J, Pitman R, et al. Sub-optimal control of allergic rhinitis: the need for a new and more effective treatment option. Allergy. 2013;68:A405.
  • Mullol J, Bartra J, del CA, et al. Specialist-based treatment reduces the severity of allergic rhinitis. Clin Exp Allergy. 2013;43:723–729.
  • Anolik R, Mometasone Furoate Nasal Spray With Loratadine Study Group. Clinical benefits of combination treatment with mometasone furoate nasal spray and loratadine vs monotherapy with mometasone furoate in the treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2008;100:264–271.
  • Esteitie R, deTineo M, Naclerio RM, et al. Effect of the addition of montelukast to fluticasone propionate for the treatment of perennial allergic rhinitis. Ann Allergy Asthma Immunol. 2010;105:155–161.
  • Canonica GW, Mullol J, Pradalier A, et al. Patient perceptions of allergic rhinitis and quality of life: findings from a survey conducted in Europe and the United States. World Allergy Organ J. 2008;1:138–144.
  • Blaiss MS. Important aspects in management of allergic rhinitis: compliance, cost, and quality of life. Allergy Asthma Proc. 2003;24:231–238.
  • Bernstein JA. MP29-02: a breakthrough for the treatment of allergic rhinitis. Expert Opin Pharmacother. 2013;14:2101–2113.
  • Bousquet J, Bachert C, Bernstein J, et al. Advances in pharmacotherapy for the treatment of allergic rhinitis; MP29-02 (a novel formulation of azelastine hydrochloride and fluticasone propionate in an advanced delivery system) fills the gaps. Expert Opin Pharmacother. 2015;16:913–928.
  • Derendorf H, Meltzer EO, Hermann R, et al. Clinical development of an advanced intranasal delivery system of azelastine hydrochloride and fluticasone propionate. Drugs Today (Barc). 2014;50:15–31.
  • Ridolo E, Montagni M, Melli V, et al. A role for the intranasal formulation of azelastine hydrochloride/fluticasone propionate in the treatment of allergic rhinitis. Ther Deliv. 2015;6:653–659.
  • Berger WE. MP29-02 for the treatment of seasonal allergic rhinitis: a review of clinical pharmacology, efficacy and safety. Expert Rev Clin Immunol. 2013;9:803–811.
  • Devillier P, Dreyfus JF, Demoly P, et al. A meta-analysis of sublingual allergen immunotherapy and pharmacotherapy in pollen-induced seasonal allergic rhinoconjunctivitis. BMC Med. 2014;12:71.
  • Azelastine and fluticasone nasal spray: any advantage?. Drug Ther Bull. 2014;52:21–24.
  • Azelastine/fluticasone propionate (Dymista) for seasonal allergic rhinitis. Med Lett Drugs Ther. 2012;54:85–87.
  • Klimek L, Sperl A. [Evidence-based treatment options for allergic diseases in otolaryngology: an update]. HNO. 2013;61:525–538.
  • Kelso JM. Combination therapy with azelastine and fluticasone nasal sprays. Ann Allergy Asthma Immunol. 2008;101:111.
  • Hampel FC, Ratner PH, Van BJ, et al. Double-blind, placebo-controlled study of azelastine and fluticasone in a single nasal spray delivery device. Ann Allergy Asthma Immunol. 2010;105:168–173.
  • Derendorf H, Munzel U, Petzold U, et al. Bioavailability and disposition of azelastine and fluticasone propionate when delivered by MP29-02, a novel aqueous nasal spray. Br J Clin Pharmacol. 2012;74:125–133.

•• This article is of considerable interest as it shows that fluticasone propionate contained within MP29-02 has a unique pharmacokinetic fingerprint which may confer efficacy advantages over commercially available fluticasone propionate but which has no safety implications

  • Meltzer EO, LaForce C, Ratner P, et al. MP29-02 (a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate) in the treatment of seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled trial of efficacy and safety. Allergy Asthma Proc. 2012;33:324–332.
  • Carr W, Bernstein J, Lieberman P, et al. A novel intranasal therapy of azelastine with fluticasone for the treatment of allergic rhinitis. J Allergy Clin Immunol. 2012;129:1282–1289.
  • Meltzer E, Ratner P, Bachert C, et al. Clinically relevant effect of a new intranasal therapy (MP29-02) in allergic rhinitis assessed by responder analysis. Int Arch Allergy Immunol. 2013;161:369–377.

•• This article is of considerable interest as it shows that although MP29-02 provides additive and over-additive efficacy advantages over commercially available fluticasone propionate or azelastine hydrochloride (assessed in a clinically relevant way), it does so without incurring a safety penalty

  • Price D, Shah S, Bhatia S, et al. A new therapy (MP29-02) is effective for the long-term treatment of chronic rhinitis. J Investig Allergol Clin Immunol. 2013;23:495–503.

• This article is of interest as it shows that MP29-02 provides significantly superior symptom relief to an intranasal corticosteroid long term

  • Berger WE, Shah S, Lieberman P, et al. Long-term, randomized safety study of MP29-02 (a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate in an advanced delivery system) in subjects with chronic rhinitis. J Allergy Clin Immunol Pract. 2014;2:179–185.

•• This article is of considerable interest as it shows that MP29-02 is well tolerated during 52 weeks of continuous use, with no evidence of an increase in the incidence of treatment-related adverse event, glaucoma or cataract, and with nonclinically relevant effects on serum cortisol concentrations or any vital sign assessed compared to an intranasal corticosteroid

  • Klimek L, Bachert C, Mosges R, et al. Effectiveness of MP29-02 for the treatment of allergic rhinitis in real-life: results from a noninterventional study. Allergy Asthma Proc. 2015;36:40–47.

•• This article is of considerable interest as it shows that MP29-02 is effective and well tolerated in real life

  • Ellis AK, Zhu Y, Steacy LM, et al. A four-way, double-blind, randomized, placebo controlled study to determine the efficacy and speed of azelastine nasal spray, versus loratadine, and cetirizine in adult subjects with allergen-induced seasonal allergic rhinitis. Allergy Asthma Clin Immunol. 2013;9:16.
  • Horak F, Zieglmayer UP. Azelastine nasal spray for the treatment of allergic and nonallergic rhinitis. Expert Rev Clin Immunol. 2009;5:659–669.
  • Roca-Ferrer J, Pujols L, Perez-Gonzalez M, et al. MP29-02 reduces both eosinophil survival and pro-inflammatory cytokines secretion from nasal epithelial cells in an in vitro model of human nasal eosinophilic inflammation. Allergy. 2015;70(Suppl. 101):4.
  • D’Addio A, Karafilidis J, Ruiz N, et al. Quantification of the distribution of MP29-02 in an anatomical model of the human nasal cavity. Allergy. 2015;70(Suppl. 101):501.
  • D’Addio A, Ruiz N, Mayer M, et al. Deposition characteristics of a new allergic rhinitis nasal spray (MP29-02) in an anatomical model of the human nasal cavity. Allergy. 2014;69:A842.
  • Dymista summary of product characteristics. 2014 [ cited 2015 Oct 30]. Available from: https://www medicines org uk/emc/medicine/27579.
  • van AA, Bronsky E, Grossman J, et al. Dose tolerance study of fluticasone propionate aqueous nasal spray in patients with seasonal allergic rhinitis. Ann Allergy. 1991;67:156–162.
  • Nathan RA, Bronsky EA, Fireman P, et al. Once daily fluticasone propionate aqueous nasal spray is an effective treatment for seasonal allergic rhinitis. Ann Allergy. 1991;67:332–338.
  • Meltzer EO, Orgel HA, Bronsky EA, et al. A dose-ranging study of fluticasone propionate aqueous nasal spray for seasonal allergic rhinitis assessed by symptoms, rhinomanometry, and nasal cytology. J Allergy Clin Immunol. 1990;86:221–230.
  • Stjarne P, Strand V, Theman K, et al. Real-life effectiveness of a new allergic rhinitis (MP29-02) in Sweden. Allergy. 2015;70(Suppl. 101):504.
  • Haahr P, Jacobsen C, Blegvad S, et al. Real life effectiveness of a new allergic rhinitis therapy (MP29-02) in Denmark. Allergy. 2015;70(Suppl. 101):500.
  • Dollner R, Lorentz Larsen P, Sheyauldeen S, et al. Real-life effectiveness of a new allergic rhinitis therapy (MP29-02) in Norway. Allergy. 2015;70(Suppl. 101):502.
  • European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). Guideline on Clinical Development of Fixed Combination Medicinal Products. CHMP/EWP/240/95 Rev. 1. 2009 February 19. [ cited 2015 Aug 5].
  • Baumann D, Bachert C, Hogger P. Dissolution in nasal fluid, retention and anti-inflammatory activity of fluticasone furoate in human nasal tissue ex vivo. Clin Exp Allergy. 2009;39:1540–1550.
  • Srinivasan M, Rahmathullah R, Blair CR, et al. Cataract progression in India. Br J Ophthalmol. 1997;81:896–900.
  • Lueng D, Szefler S. Associated Editors of the JACI. MP29-02: a major advancement in the treatment of allergic rhinitis. J Allergy Clin Immunol. 2012;129:1216.
  • Muley P, Shah M, Muley A. Safety of inhaled fluticasone propionate therapy for pediatric asthma - a systematic review. Curr Drug Saf. 2013;8:186–194.
  • Klimek L, Sperl A, Spielhaupter M, et al. Olfactory function is improved by MP29-02 in patients with persistent allergic rhinitis. Allergy. 2015;70(Suppl. 101):502.
  • Macchi A, Gelardi M, Landi M, et al. Cellular rhinitis. Clin Transl Allergy. 2015;5(Suppl. 4):P43.
  • Harrow B, Sedaghat A, Munzel U, et al. Health-care costs of asthma are lower using MP29-02 versus sequential sprays for allergic rhinitis. Allergy. 2015;70(Suppl. 101):501.

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