G. Ciprandi et al., SEASONAL RHINITIS AND AZELASTINE - LONG-TERM OR SHORT-TERM TREATMENT, Journal of allergy and clinical immunology, 99(3), 1997, pp. 301-307
Background: Azelastine is a topical antihistamine, clinically demonstr
ated to be effective in allergic rhinitis. Objective: We evaluated the
clinical efficacy and the antiallergic activity of azelastine nasal s
pray, administered 0.56 mg per day, 0.28 mg per day, or on demand over
a 3-month period during natural allergen exposure, in a double-blind,
placebo-controlled fashion. Methods: Thirty patients, sensitized to g
rass or Parietaria pollen, were allocated to three treatment groups: t
hose receiving the standard dosage (0.14 mg/nostril two times a day),
half the dosage (0.07 mg/nostril two times a day), or placebo daily fo
r 3 months. All patients were allowed to take additional doses of azel
astine when needed. Evaluation parameters were as follows: clinical sy
mptoms recorded on a diary card, number of additional, on-demand azela
stine puffs, nasal inflammatory cell count, intercellular adhesion mol
ecule-1 expression on nasal epithelial cells, and pollen count. Result
s: This study showed the following: (1) the half dose (0.28 mg/day) an
d the standard dose (0.56 mg/day) were equally effective in reducing c
linical symptoms (p = NS), although the standard dosage required fewer
additional puffs during times of peak pollen counts (p < 0.05); (2) b
oth dosages were able to reduce the allergic inflammation (p < 0.05 vs
placebo); and (3) on-demand use achieved acceptable clinical control
but did not significantly reduce allergic inflammation. Conclusion: Co
ntinuous treatment was more effective than on-demand use as assessed b
y both clinical evaluation and antiinflammatory action.