Clinically relevant effect of a new intranasal therapy (MP29-02) in allergic rhinitis assessed by responder analysis

International Archives of Allergy and Immunology

Volumn 161, Issue 4, 2013, Pages 369-377

  Meltzer, Eli ^a   Ratner, Paul ^c   Bachert, Claus ^g   Carr, Warner ^b   Berger, William ^b   Canonica, G Walter ^h   Hadley, James ^e   Lieberman, Phil ^f   Hampel, Frank C ^d   Mullol, Joaquim ⁱ   Munzel, Ullrich ^j   Price, David ^m   Scadding, Glenis ⁿ   Virchow, J Christian ^k   Wahn, Ulrich ^l   Murray, Ruth ^o   Bousquet, Jean ^p  

^a ALLERGY AND ASTHMA MEDICAL GROUP AND RESEARCH CENTER   (United States)

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

^c Sylvana Research   (United States)

^d Central Texas Health Research   (United States)

^e UNIVERSITY OF ROCHESTER MEDICAL CENTER   (United States)

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

^g GHENT UNIVERSITY HOSPITAL   (Belgium)

^h UNIVERSITY OF GENOA   (Italy)

ⁱ INSTITUT D INVESTIGACIONS BIOMÈDIQUES AUGUST PI I SUNYER IDIBAPS   (Spain)

^j MEDA Pharma GmbH and Co KG   (United Kingdom)

^k ROSTOCK UNIVERSITY MEDICAL CENTER   (Germany)

^l CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^m UNIVERSITY OF ABERDEEN   (United Kingdom)

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

^o MedScript ^*  (Ireland)

^p HÔPITAL ARNAUD DE VILLENEUVE   (France)

more..

Author keywords

Allergic rhinitis; Azelastine; Fluticasone; MP29 02; Responder analysis; Severe chronic upper airway disease

Indexed keywords

AZELASTINE; AZELASTINE PLUS FLUTICASONE PROPIONATE; FLUTICASONE PROPIONATE; MP 29 02; PLACEBO; UNCLASSIFIED DRUG;

ALLERGIC RHINITIS; ARTICLE; DISEASE SEVERITY; DRUG EFFICACY; HUMAN; MAJOR CLINICAL STUDY; PHASE 3 CLINICAL TRIAL (TOPIC); POST HOC ANALYSIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); TREATMENT RESPONSE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFECT; INTENTION TO TREAT ANALYSIS; INTRANASAL DRUG ADMINISTRATION; OUTCOME ASSESSMENT; RANDOMIZED CONTROLLED TRIAL; TREATMENT DURATION;

ADULT; ANDROSTADIENES; ANTI-ALLERGIC AGENTS; CEDRUS; DISEASE PROGRESSION; DRUG COMBINATIONS; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MIDDLE AGED; NASAL OBSTRUCTION; PHTHALAZINES; RHINITIS, ALLERGIC, SEASONAL; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84877679580     PISSN: 10182438     EISSN: 14230097     Source Type: Journal    
DOI: 10.1159/000351404     Document Type: Article

References (33)

1. Brozek JL, Bousquet J, Baena-Cagnani CE, Bonini S, Canonica GW, Casale TB, van Wijk RG, Ohta K, Zuberbier T, Schunemann HJ, Global Allergy and Asthma European Network, Grading of Recommendations Assessment, Development and Evaluation Working Group: Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 revision. J Allergy Clin Immunol 2010; 126: 466-476
2. Canonica GW, Bousquet J, Mullol J, Scadding GK, Virchow JC: A survey of the burden of allergic rhinitis in Europe. Allergy 2007; 62: 17-25
3. Schatz M: A survey of the burden of allergic rhinitis in the USA. Allergy 2007; 62: 9-16
4. Hellings PW, Fokkens WJ, Akdis C, Bachert C, Cingi C, Dietz de Loos D, Gevaert P, Hox V, Kalogjera L, Lund V, Mullol J, Papadopoulos NG, Passalacqua G, Rondon C, Scadding G, Timmermans M, Toskala E, Zhang N, Bousquet J: Uncontrolled allergic rhinitis and chronic rhinosinusitis: Where do we stand today? Allergy 2013; 68: 1-7
5. Bousquet J, Bachert C, Canonica GW, Casale TB, Cruz AA, Lockey RJ, Zuberbier T, Extended Global Allergy and Asthma European Network, World Allergy Organization and Allergic Rhinitis and its Impact on Asthma Study Group: Unmet needs in severe chronic upper airway disease (SCUAD). J Allergy Clin Immunol 2009; 124: 428-433
6. Meltzer EO, Gross GN, Katial R, Storms WW: Allergic rhinitis substantially impacts patient quality of life: Findings from the Nasal Allergy Survey Assessing Limitation. J Fam Pract 2012; 61:S5-S10
7. Walker S, Khan-Wasti S, Fletcher M, Cullinan P, Harris J, Sheikh A: 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
8. Vandenplas O, D'Alpaos V, Van Brussel P: Rhinitis and its impact on work. Curr Opin Allergy Clin Immunol 2008; 8: 145-149
9. Hellgren J, Crevin A, Nordling S, Bergman A, Cardell LO: Allergic rhinitis and the common cold - high cost to society. Allergy 2010; 65: 776-783
10. Bousquet J, Khaltaev N, Cruz AA, Denburg J, Fokkens WJ, Togias A, 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: 8-160
11. Wallace DV, Dykewicz MS, Bernstein DI, Blessing-Moore J, Cox L, Khan DA, et al: The diagnosis and management of rhinitis: An updated practice parameter. J Allergy Clin Immunol 2008; 122:S1-S84
12. 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
13. 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:S107-S124
14. Virchow JC, Kay S, Demoly P, Mullol J, Canonica W, Higgins V: Impact of ocular symptoms on quality of life (QoL), work productivity and resource utilisation in allergic rhinitis patients - an observational, cross sectional study in four countries in Europe. J Med Econ 2011; 14: 305-314
15. Stull DE, Schaefer M, Crespi S, Sandor DW: Relative strength of relationships of nasal congestion and ocular symptoms with sleep, mood and productivity. Curr Med Res Opin 2009; 25: 1785-1792
16. Demoly P, Allaert FA, Lecasble M, PRAGMA: ERASM, a pharmacoepidemiologic survey on management of intermittent allergic rhinitis in everyday general practice in France. Allergy 2002; 57: 546-554
17. Bousquet PJ, Demoly P, Devillier P, Mesbah K, Bousquet J: Impact of allergic rhinitis symptoms on quality of life in primary care. Int Arch Allergy Immunol 2013; 160: 393-400
18. 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, June 16-20, 2012
19. Snapinn SM, Jiang Q: Responder analyses and the assessment of a clinically relevant treatment effect. Trials 2007; 8: 31
20. EMA guideline: Guideline on the clinical development of medicinal products for the treatment of allergic rhinoconjunctivitis. October 2004. http://www.ema.europa.eu/docs/ en-GB/document-library/Scientific-guideline/ 2009/09/WC500003554.pdf (accessed June 17, 2011).
21. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health: Guidance for industry - patient-reported outcome measures: Use in medical product development to support labeling claims. December 2009. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/ Guidances/UCM193282.pdf (accessed November 28, 2012).
22. Hampel FC, Ratner PH, Van Bavel J, Amar JJ, Daftary P, Wheeler W, Sacks H: Doubleblind, placebo-controlled study of azelastine and fluticasone in a single nasal spray delivery device. Ann Allergy Asthma Immunol 2010; 105: 168-173
23. 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- 1289
24. Juniper EF, Guyatt GH: Development and testing of a new measure of health status for clinical trials in rhinoconjunctivitis. Clin Exp Allergy 1991; 21: 77-83
25. Klossek JM, Annesi-Maesano I, Pribil C, Didier A: The burden associated with ocular symptoms in allergic rhinitis. Int Arch Allergy Immunol 2012; 158: 411-417
26. Bousquet J, Lund VJ, Van Cauwenberg P, Bremard-Oury C, Mounedji N, Stevens MT, El-Akkad T: Implementation of guidelines for seasonal allergic rhinitis: A randomized controlled trial. Allergy 2003; 58: 733-741
27. Bousquet J, Bodez T, Gehano P, Klossek JM, Liard F, Neukirch F, Le Gal M, Janin N, Allaf B: Implementation of guidelines for allergic rhinitis in specialist practices: A randomized pragmatic controlled trial. Int Arch Allergy Immunol 2009; 150: 75-82
28. Rodrigo GJ, Neffen H: Efficacy of fluticasone furoate nasal spray vs. placebo for the treatment of ocular and nasal symptoms of allergic rhinitis: A systematic review. Clin Exp Allergy 2011; 41: 160-170
29. Bielory L, Chun Y, Bielory BP, Canonica GW: Impact of mometasone furoate nasal spray on individual ocular symptoms of allergic rhinitis: A meta-analysis. Allergy 2011; 66: 686-693
30. Costa DJ, Amouyal M, Lambert P, Ryan D, Schunemann HJ, Daures JP, Bousquet J, Bousquet PJ, Languedoc-Roussillon Teaching General Practitioners Group: How representative are clinical study patients with allergic rhinitis in primary care? J Allergy Clin Immunol 2011; 127: 920-926
31. Okubo K, Nakashima M, Miyake N, Komatsubara M, Okuda M: Comparison of fluticasone furoate and fluticasone propionate for the treatment of Japanese cedar pollinosis. Allergy Asthma Proc 2009; 30: 84-94
32. Mandl M, Molop K, Lutsky BN: Comparison of once daily mometasone furoate (Nasonex) and fluticasone propionate aqueous nasal sprays for the treatment of perennial rhinitis: 194-079 Study Group. Ann Allergy Asthma Immunol 1997; 79: 370-378
33. Price D, Bousquet J, Helling P, Scadding G, Fokkens W, Munzel U, Bachert C: Short and long-term safety of MP29-02 : A new therapy for the treatment of allergic rhinitis. Presented at SERIN congress, Leuven, Belgium, March 21-23, 2013