• Immunotherapy · Nov 2017

    Randomized Controlled Trial Multicenter Study

    Dose-finding study of carbamylated monomeric allergoid tablets in grass-allergic rhinoconjunctivitis patients.

    • Ralph Mösges, Christina Rohdenburg, Andrea Eichel, Gregor Zadoyan, Elena-Manja Kasche, Kija Shah-Hosseini, Walter Lehmacher, Petra Schmalz, and Enrico Compalati.
    • Institute of Medical Statistics, Informatics and Epidemiology, Medical Faculty, University of Cologne, Cologne, Germany.
    • Immunotherapy. 2017 Nov 1; 9 (15): 1225-1238.

    AimTo determine the optimal effective and safe dose of sublingual immunotherapy tablets containing carbamylated monomeric allergoids in patients with grass pollen-induced allergic rhinoconjunctivitis.MethodsIn this prospective, randomized, double-blind, active-controlled, multicenter, Phase II study, four different daily doses were applied preseasonally for 12 weeks.ResultsOf 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.ConclusionThis study found 1000 UA/day to be the optimal effective and safe dose.

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