Background: Nasal congestion is the predominant symptom in perennial allerg
ic rhinitis (PAR), and it seems to be mainly related to the late-phase infl
ammatory events. The present pilot Study aimed to evaluate the therapeutic
effect exerted by fexofenadine in patients with PAR due to mite allergy.
Methods: This study was a parallel, double-blind, randomized. three-arm(1:1
:1), placebo-controlled study. Thirty-one subjects with PAR were enrolled a
nd received double-blind medication: fexofenadine 120 or 180 mg, or placebo
. once a day for 28 days.
Results: The total symptom score was reduced by fexofenadine (both dosages)
at V2 (P=0.007), whereas placebo did not modify it. Nasal congestion decre
ased after I week of treatment with fexofenadine 120 (P=0.027) and 180 (P=0
.01), but not with placebo (P=NS). At V3, fexofenadine (both dosages) signi
ficantly reduced nasal congestion (P=0.011 and P=0.007, respectively), by p
lacebo did not show any significant effect.
Conclusions: This pilot study represents the first evidence of the efficacy
of fexofenadine in PAR, and also the control of the nasal congestion. We s
uggest performing larger trials to confirm these preliminary findings.