Moesges, Ralph, Rohdenburg, Christina, Eichel, Andrea, Zadoyan, Gregor, Kasche, Elena-Manja, Shah-Hosseini, Kija ORCID: 0000-0001-9616-6942, Lehmacher, Walter, Schmalz, Petra and Compalati, Enrico (2017). Dose-finding study of carbamylated monomeric allergoid tablets in grass-allergic rhinoconjunctivitis patients. Immunotherapy, 9 (15). S. 1225 - 1239. LONDON: FUTURE MEDICINE LTD. ISSN 1750-7448

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Abstract

Aim: To determine the optimal effective and safe dose of sublingual immunotherapy tablets containing carbamylated monomeric allergoids in patients with grass pollen-induced allergic rhinoconjunctivitis. Methods: In this prospective, randomized, double-blind, active-controlled, multicenter, Phase II study, four different daily doses were applied preseasonally for 12 weeks. Results: Of 158 randomized adults, 155 subjects (safety population) received 300 units of allergy (UA)/day (n=36), 600 UA/day (n=43), 1000 UA/day (n=39), or 2000 UA/day (n=37). After treatment, 54.3, 47.6, 59.0 and 51.4% of patients, respectively, ceased to react to the highest allergen concentration in a conjunctival provocation test. Furthermore, the response threshold improved in 70.4, 62.9, 76.7 and 66.7% of patients, respectively. No serious adverse events occurred. Conclusion: This study found 1000 UA/day to be the optimal effective and safe dose.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Moesges, RalphUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rohdenburg, ChristinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eichel, AndreaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zadoyan, GregorUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kasche, Elena-ManjaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Shah-Hosseini, KijaUNSPECIFIEDorcid.org/0000-0001-9616-6942UNSPECIFIED
Lehmacher, WalterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmalz, PetraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Compalati, EnricoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-212556
DOI: 10.2217/imt-2017-0058
Journal or Publication Title: Immunotherapy
Volume: 9
Number: 15
Page Range: S. 1225 - 1239
Date: 2017
Publisher: FUTURE MEDICINE LTD
Place of Publication: LONDON
ISSN: 1750-7448
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
SUBLINGUAL IMMUNOTHERAPY; DOUBLE-BLIND; CLINICAL-EFFICACY; PROVOCATION TEST; POLLEN; SAFETY; RHINITIS; EXTRACT; CONJUNCTIVAL; TRIALSMultiple languages
ImmunologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/21255

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