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Objective: To
measure the
reduction in nasal
obstruction using
acoustic rhinometry
in patients with
allergic rhinitis
treated with
rupatadine.
Methods: We
performed a
randomized,
double-blind,
cross-over,
placebo-controlled
clinical trial in
asymptomatic
patients with
allergic rhinitis.
Patients received
rupatadine 10 mg or
placebo once daily
for 3 days, in 2
subsequent periods
separated by a
washout interval of
14 days. We
performed a nasal
allergen challenge
during each period,
and measured nasal
volume using
acoustic rhinometry
and nasal nitric
oxide (nNO) at
baseline, and at 2
hours and 24 hours
after the challenge.
We also evaluated
nasal symptoms (rhinorrhea,
itching,
obstruction, and
sneezing), as well
as total symptom
score (T4SS) at the
same time points as
for the primary
objective.
Results: The
study population
comprised 30
outpatients with a
mean (SD) age of 28
(10) years. Nasal
airway blockage was
significantly lower
in the rupatadine
group than in the
placebo group (47%,
P<.05) at 2 hours
postchallenge. nNO
in the rupatadine-treated
patients remained
unaltered, unlike in
the placebo-treated
group, where levels
decreased at 2
hours. After
treatment with
rupatadine, patients
showed a lower
decrease in the mean
total symptoms score
at 2 hours (3.6
[2.6]) compared with
placebo (3.9 [2.9]),
although these
differences did not
achieve statistical
significance.
Overall, rupatadine
was well tolerated
and no serious or
unexpected adverse
events were
observed.
Conclusions:
Rupatadine 10 mg can
reduce nasal
obstruction assessed
by objective
measures and is well
tolerated in
patients with
allergic rhinitis.
Key words:
Acoustic rhinometry.
Nasal obstruction.
Nasal allergen
challenge.
Rupatadine.
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