Population
The study populations in the phase-II and phase-III trials comprised
adolescents and adults (12-65 years) with persistent moderate-to-severe
allergic rhinitis and/or conjunctivitis induced by birch pollen despite
having received symptom-relieving medication during the 2 previous tree
pollen seasons. Subjects had to have a positive skin prick test response
(wheal diameter, >3mm) to birch, a positive Bet v
1–specific IgE level (IgE class 2 or greater, >0.7 kU/L),
and affected quality-of-life items (sleep disturbance; impairment of
daily activities, leisure, and/or sport; impairment of school or work;
or troublesome symptoms) because of allergic rhinitis and/or
conjunctivitis during the previous birch pollen season. Subjects with
uncontrolled asthma or severe asthma exacerbations were excluded from
the trial.
The subjects in the pooled safety analysis data set (hereafter called
‘pooled population’) comprised
subjects from the mentioned phase-II and phase-III trials who were
randomized to a daily dose of 12 SQ-Bet or placebo and received at least
one dose of treatment.