A new therapy (MP29-02) is effective for the long-term treatment of chronic rhinitis

Journal of Investigational Allergology and Clinical Immunology

Volumn 23, Issue 7, 2013, Pages 495-503

  Price, D ^a   Shah, S ^b   Bhatia, S ^c   Bachert, C ^d   Berger, W ^e   Bousquet, J ^f   Carr, W ^e   Hellings, P ^g   Munzel, U ^h   Scadding, G ⁱ   Lieberman, Phil ^j  

^a UNIVERSITY OF ABERDEEN   (United Kingdom)

^b Allergy and Asthma Consultants NJ/PA   (United States)

^c IRL Clinical Research Centre   (India)

^d GHENT UNIVERSITY HOSPITAL   (Belgium)

^e Allergy & Asthma Associates of Southern California   (United States)

^f HÔPITAL ARNAUD DE VILLENEUVE   (France)

^g UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^h MEDA Pharma GmbH and Co KG   (Germany)

ⁱ ROYAL NATIONAL THROAT NOSE AND EAR HOSPITAL   (United Kingdom)

^j UNIVERSITY OF TENNESSEE COLLEGE OF MEDICINE   (United States)

more..

Author keywords

Chronic rhinitis; Dymista; Efficacy; Fluticasone propionate; Long term; Perennial allergic rhinitis; Responder analysis; Symptom free days

Indexed keywords

AZELASTINE PLUS FLUTICASONE PROPIONATE; FLUTICASONE PROPIONATE;

ADOLESCENT; ADULT; AGED; ARTICLE; CHRONIC RHINITIS; CONTROLLED STUDY; DRUG SAFETY; DRUG TOLERANCE; FEMALE; FOLLOW UP; HUMAN; MAJOR CLINICAL STUDY; MALE; OPEN STUDY; PERENNIAL RHINITIS; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; TREATMENT RESPONSE; VASOMOTOR RHINITIS;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANDROSTADIENES; CHILD; CHRONIC DISEASE; DRUG COMBINATIONS; FEMALE; HUMANS; MALE; MIDDLE AGED; PHTHALAZINES; RHINITIS;

EID: 84884550605     PISSN: 10189068     EISSN: 16980808     Source Type: Journal    
DOI: None     Document Type: Article

References (37)

1. Bousquet J, Khaltaev N, Cruz AA, Denburg J, Fokkens WJ, Togias A, Zuberbier T, Baena-Cagnani CE, Canonica GW, van Weel C, Agache I, Ait-Khaled N, Bachert C, Blaiss MS, Bonini S, Boulet LP, Bousquet PJ, Camargos P, Carlsen KH, Chen Y, Custovic A, Dahl R, Demoly P, Douagui H, Durham SR, van Wijk RG, Kalayci O, Kaliner MA, Kim YY, Kowalski ML, Kuna P, Le LT, Lemiere C, Li J, Lockey RF, Mavale-Manuel S, Meltzer EO, Mohammad Y, Mullol J, Naclerio R, O'Hehir RE, Ohta K, Ouedraogo S, Palkonen S, Papadopoulos N, Passalacqua G, Pawankar R, Popov TA, Rabe KF, Rosado-Pinto J, Scadding GK, Simons FE, Toskala E, Valovirta E, van Cauwenberge P, Wang DY, Wickman M, Yawn BP, Yorgancioglu A, Yusuf OM, Zar H, Annesi-Maesano I, Bateman ED, Ben Kheder A, Boakye DA, Bouchard J, Burney P, Busse WW, Chan-Yeung M, Chavannes NH, Chuchalin A, Dolen WK, Emuzyte R, Grouse L, Humbert M, Jackson C, Johnston SL, Keith PK, Kemp JP, Klossek JM, Larenas-Linnemann D, Lipworth B, Malo JL, Marshall GD, Naspitz C, Nekam K, Niggemann B, Nizankowska-Mogilnicka E, Okamoto Y, Orru MP, Potter P, Price D, Stoloff SW, Vandenplas O, Viegi G, Williams D; World Health Organization; GA(2)LEN; AllerGen. 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.
2. Bousquet J, Fokkens W, Burney P, Durham SR, Bachert C, Akdis CA, Canonica GW, Dahlen SE, Zuberbier T, Bieber T, Bonini S, Bousquet PJ, Brozek JL, Cardell LO, Crameri R, Custovic A, Demoly P, van Wijk RG, Gjomarkaj M, Holland C, Howarth P, Humbert M, Johnston SL, Kauffmann F, Kowalski ML, Lambrecht B, Lehmann S, Leynaert B, Lodrup-Carlsen K, Mullol J, Niggemann B, Nizankowska-Mogilnicka E, Papadopoulos N, Passalacqua G, Schunemann HJ, Simon HU, Todo-Bom A, Toskala E, Valenta R, Wickman M, Zock JP. Important research questions in allergy and related diseases: nonallergic rhinitis: a GA2LEN paper. Allergy. 2008;63:842-53.
3. Meltzer EO. Allergic rhinitis: the impact of discordant perspectives of patient and physician on treatment decisions. Clin Ther 2007;29:1428-40.
4. Maurer M, Zuberbier T. Under treatment of rhinitis symptoms in Europe: findings from a cross-sectional questionnaire survey. Allergy. 2007;62:1057-63.
5. Settipane RA, Lieberman P. Update on nonallergic rhinitis. Ann Allergy Asthma Immunol. 2001;86:494-507.
6. Arbes SJ, Jr., Gergen PJ, Elliott L, Zeldin DC. Prevalences of positive skin test responses to 10 common allergens in the US population: results from the third National Health and Nutrition Examination Survey. J Allergy Clin Immunol. 2005;116:377-83.
7. Mosges R, Klimek L. Today's allergic rhinitis patients are different: new factors that may play a role. Allergy. 2007;62:969-75.
8. Kaliner MA. Nonallergic rhinopathy (formerly known as vasomotor rhinitis). Immunol Allergy Clin North Am. 2011;31:441-55.
9. Canonica GW, Bousquet J, Mullol J, Scadding GK, Virchow JC. A survey of the burden of allergic rhinitis in Europe. Allergy. 2007; 62(Suppl 85):17-25.
10. Bachert C, van Cauwenberge P, Olbrecht J, van Schoor J. Prevalence, classification and perception of allergic and nonallergic rhinitis in Belgium. Allergy. 2006;61:693-8.
11. Schatz M. A survey of the burden of allergic rhinitis in the USA. Allergy. 2007; 62 (Suppl 85):9-16.
12. Meltzer EO, Gross GN, Katial R, Storms WW. Allergic rhinitis substantially impacts patient quality of life: findings from the Nasal Allergy Survey Assessing Limitations. J Fam Pract. 2012;62(2 suppl):S5-10.
13. Nathan RA. The burden of allergic rhinitis. Allergy Asthma Proc. 2007; 28:3-9.
14. Hampel FC, Ratner PH, Van Bavel J, Amar NJ, Daftary P, Wheeler W, Sacks H. Double blind, placebo-controlled study of azelastine and fluticasone in a single nasal spray delivery device. Ann Allergy Asthma Immunol. 2010;105:168-73.
15. Carr W, Bernstein J, Lieberman P, Meltzer E, Bachert C, Price D, Munzel U, Bousquet J. A novel intranasal therapy of azelastine with fluticasone for the treatment of allergic rhinitis. J Allergy Clin Immunol. 2012;129:1282-9.
16. Meltzer EO, LaForce C, Ratner P, Price D, Ginsberg D, Carr W. MP29-02 (a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate) in the treatment of seasonal allergic rhinitis: a randomized, double-blind, placebocontrolled trial of efficacy and safety. Allergy Asthma Proc. 2012;33:324-32.
17. Price D, Bousquet J, Bachert C, Berger W, Bhatia S, Carr W, Munzel U, Lieberman P. MP29-02 a novel intranasal therapy for the treatment of chronic rhinitis: safety data from a 12-month trial. Abstract presented at the European Academy of Allergy & Clinical Immunology Congress, Geneva, Switzerland 2012; 16- 20 June.
18. International Committee on Harmonization Harmonized Tripartite Guidelines on Good Clinical Practice (1996). [cited 2011 June 17]. Available from http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/ Step4/E6_R1__Guideline.pdf).
19. FDA Guideline. Guidance for Industry. Allergic rhinitis: clinical development programs for drug programs. US Department of Health and Human Services, FDA Center for Drug Evaluation and Research, April 2000. [cited 2011 June 17]. Available from http://www.fda.gov/downloads/Drugs/.GuidanceComplianceRegulatoryInformation/Guidances/ucm071293.pdf).
20. EMA guideline. Guideline on the Clinical Development of Medicinal Products for the Treatment of Allergic Rhinoconjunctivitis. CHMP/EWP/2455/02, October 2004. [cited 2011 June 17]. Available from http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003554.pdf).
21. McPherson K, Leydon G. Quantitative and qualitative methods in UK health research: then, now and.? Eur J Cancer Care. 2002;11:225-31.
22. Costa DJ, Amouyal M, Lambert P. How representative are clinical study patients with allergic rhinitis in primary care? J Allergy Clin Immunol. 2011;127:920-6.
23. Bousquet J, Neukirch F, Bousquet PJ, Gehano P, Klossek JM, Le Gal M, Allaf B. Severity and impairment of allergic rhinitis in patients consulting in primary care. J Allergy Clin Immunol. 2006;117:158-62.
24. Rosenblut A, Bardin PG, Muller B, Faris MA, Wu WW, Caldwell MF, Fokkens WJ. Long-term safety of fluticasone furoate nasal spray in adults and adolescents with perennial allergic rhinitis. Allergy. 2007;62:1071-7.
25. Minshall E, Ghaffar O, Cameron L, O'Brien F, Quinn H, Rowe- Jones J, Davies RJ, Prior A, Lund VJ, Mackay IS, Nolop K, Lutsky B, Durham SR, Hamid Q. Assessment by nasal biopsy of long-term use of mometasone furoate aqueous nasal spray (Nasonex) in the treatment of perennial rhinitis. Otolaryngol Head Neck Surg. 1998;118:648-54.
26. Klossek JM, Laliberte F, Laliberte MF, Mounedji N, Bousquet J. Local safety of intranasal triamcinolone acetonide: clinical and histological aspects of nasal mucosa in the long-term treatment of perennial allergic rhinitis. Rhinology. 2001;39:17-22.
27. Vasar M, Houle PA, Douglass JA, Meltzer EO, Silvey M, Wu W, Caldwell M, Philpot E. Fluticasone furoate nasal spray: effective monotherapy for symptoms of perennial allergic rhinitis in adults/adolescents. Allergy Asthma Proc. 2008;29:313-21.
28. Nathan RA, Berger W, Yang W, Cheema A, Silvey M, Wu W, Philpot E. Effect of once-daily fluticasone furoate nasal spray on nasal symptoms in adults and adolescents with perennial allergic rhinitis. Ann Allergy Asthma Immunol. 2008;100:497-505.
29. Given JT, Cheema AS, Dreykluft T, Stillerman A, Silvey M, Wu W, Snowise NG, Philpot E. Fluticasone furoate nasal spray is effective and well tolerated for perennial allergic rhinitis in adolescents and adults. Am J Rhinol Allergy. 2010;24:444-50.
30. Yamada T, Yamamoto H, Kubo S, Sakashita M, Tokunaga T, Susuki D, Narita N, Ogi K, Kanno M, Yamashita S, Terasawa Y, Kayano Y, Masada M, Fujieda S. Efficacy of mometasone furoate nasal spray for nasal symptoms, quality of life, rhinitis-disturbed sleep and nasal nitric oxide in patients with perennial allergic rhinitis. Allergy Asthma Proc. 2012;33:e9-16.
31. Clement P, Gates D. Symptom suppression in subjects with perennial allergic rhinitis with mometasone furoate nasal spray. Int Arch Allergy Immunol. 2012;157:387-90.
32. Maspero JF, Rosenblut A, Finn A Jr, Lim J, Wu W, Philpot E. Safety and efficacy of fluticasone furoate in pediatric patients with perennial allergic rhinitis; Otolaryngol Head Neck Surg. 2008;138:30-7.
33. Ratner PH, Meltzer EO, Teper A. Mometasone furoate nasal spray is safe and effective for 1-year treatment of children with perennial allergic rhinitis. Int J Pediatr Otorhinolaryngol. 2009;73:651-7.
34. Hellgren J, Cervin A, Nordling S, Bergman A, Cardell LO. Allergic rhinitis and the common cold - high cost to society. Allergy. 2010;65:776-83.
35. Pitman R, Paracha N, Parker C, Acaster S, Bachert C, Bousquet J, Price D. Episode pattern and healthcare utilisation in patients with seasonal allergic rhinitis. Presented at EAACI, Geneva, 16-20 June 2012.
36. Marple BF, Fornadley JA, Patel AA, Fineman SM, Fromer L, Krouse JH, Lanier BQ, Penna P; American Academy of Otolaryngic Allergy Working Group on Allergic Rhinitis. Keys to successful management of patients with allergic rhinitis: focus on patient confidence, compliance, and satisfaction. Otolaryngol Head Neck Surg. 2007; 136(6 Suppl):S107-24.
37. Acaster S, Ali S, Breheny K, Bachert C, Bousquet J, Price D. Treatment preferences in patients with moderate/severe seasonal allergic rhinitis: findings of a discrete choice experiment. Presented at EAACI, Geneva, 16-20 June 2012.