Methods
The SQ tree SLIT-tablet is a fast-dissolving pharmaceutical formulation
(oral lyophilisate) for daily at-home self-administration apart from the
first tablet, that must be administered at the clinic. It contains
standardised allergen extract from white birch pollen (Betula
verrucosa ).
Trial
design
Safety data were pooled from two phase-II and one pivotal phase-III
double-blinded, randomized placebo-controlled, parallel-group trials
including adults and adolescents with moderate to severe allergic
rhinitis and/or conjunctivitis induced by pollen from the birch
homologous group. The data included subjects who received placebo or a
daily dose of 12 SQ-Bet. The trials were conducted at 124 sites in total
in Canada, Czech Republic, Denmark, France, Germany, Finland, Lithuania,
the Netherlands, Norway, Poland, Russia and Sweden.
The subjects were treated before and during one pollen season with
once-daily SQ tree SLIT-tablet or placebo administered at home. The
first dose was administered under medical supervision for 30 minutes
after tablet intake to assess tolerability and allow for possible
treatment of any immediate side effects. The design as well as efficacy
and safety results of the phase II trials and the pivotal phase-III
trial have been described separately elsewhere13-15.