1. A randomized DBPC trial to determine the optimal effective and safe dose of a SLIT-birch pollen extract for the treatment of allergic rhinitis
- Author
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J. D. Boot, R. van Ree, Dirk-Jan Opstelten, E van Twuijver, Oliver Pfaar, Zuzana Diamant, P. Panzner, Piotr Kuna, Ludger Klimek, AII - Amsterdam institute for Infection and Immunity, APH - Amsterdam Public Health, and Experimental Immunology
- Subjects
Male ,0301 basic medicine ,SYMPTOMS ,Phases of clinical research ,nasal provocation ,medicine.disease_cause ,Immunoglobulin E ,Gastroenterology ,DOUBLE-BLIND ,0302 clinical medicine ,Allergen ,Immunology and Allergy ,birch pollen ,Betula ,biology ,dose finding ,Middle Aged ,Slit ,Treatment Outcome ,Tolerability ,Pollen ,Female ,Original Article ,POSITION PAPER ,Adult ,Allergen immunotherapy ,medicine.medical_specialty ,Adolescent ,Airway Diseases ,Immunology ,DIAGNOSIS ,sublingual immunotherapy ,PARAMETERS ,Medication Adherence ,Young Adult ,03 medical and health sciences ,Internal medicine ,Immune Tolerance ,medicine ,Humans ,CLINICAL-EFFICACY ,Skin Tests ,Asthma ,Plant Extracts ,business.industry ,Rhinitis, Allergic, Seasonal ,Allergens ,medicine.disease ,RHINOCONJUNCTIVITIS ,030104 developmental biology ,030228 respiratory system ,Desensitization, Immunologic ,biology.protein ,allergen immunotherapy ,ASTHMA ,ORIGINAL ARTICLES ,business ,FOLLOW-UP - Abstract
Background: Sublingual immunotherapy (SLIT) is a potential efficacious and safe treatment option for patients with respiratory, IgE-mediated allergic diseases. A combined tolerability, dose-finding study with a sublingual liquid birch pollen preparation (SB) was conducted.Methods: Two hundred and sixty-nine adults with birch-pollen-induced AR were randomized to placebo, SB: 3333, 10 000, 20 000 or 40 000 AUN/ml. Differences in symptom scores following a titrated nasal provocation test (TNPT) at baseline and after 5 months of treatment were determined. Safety, tolerability, birch-pollen- specific immunoglobulin levels and peak nasal inspiratory flow (PNIF) were also measured (all measures determined outside the birch pollen season).Results: In all treatment groups, an improvement in symptom scores after treatment compared to baseline was observed, with an additional stepwise improvement in the active groups compared to placebo, which was significant in high-dose groups (P = 0.008 and P Conclusions: A multicentre trial evaluated the dose-response and tolerability of SB. All active treatment groups showed better responses than placebo for both primary and secondary parameters. The results indicate that, within the studied dose range, SB 40 000 AUN/ml is the most optimal effective and safe dose (ClinicalTrials.gov: NCT01639768).
- Published
- 2016