Dose-finding study of carbamylated monomeric allergoid tablets in grass-allergic rhinoconjunctivitis patients
| Autor: | Andrea Eichel, Ralph Mösges, Christina Rohdenburg, Enrico Compalati, Petra Schmalz, Walter Lehmacher, Elena-Manja Kasche, G Zadoyan, Kija Shah-Hosseini |
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| Rok vydání: | 2017 |
| Předmět: |
Adult
Male Allergy medicine.medical_specialty Adolescent Immunology Population Phases of clinical research Poaceae Gastroenterology Young Adult 03 medical and health sciences Dose finding 0302 clinical medicine Double-Blind Method Internal medicine Humans Immunology and Allergy Medicine Drug Dosage Calculations Sublingual immunotherapy In patient 030212 general & internal medicine education Adverse effect Aged Conjunctivitis Allergic Sublingual Immunotherapy education.field_of_study business.industry Allergens Antigens Plant Middle Aged medicine.disease Rhinitis Allergic Allergoid 030228 respiratory system Oncology Pollen Female business Tablets |
| Zdroj: | Immunotherapy. 9:1225-1238 |
| ISSN: | 1750-7448 1750-743X |
| DOI: | 10.2217/imt-2017-0058 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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