A sequential therapy treatment with azelastine (Allergodil(R)) in seasonal
allergic rhinitis is introduced. In the critical early stage, treatment beg
ins with a combination of azelastine tablets (azelastine hydrochloride, CAS
79307-93-0) and azelastine nasal spray (azelastine, CAS 58581-89-8), and a
fter five days only the nasal spray is administered. This sequential therap
y model aims at achieving the quickest and most complete effect without red
ucing the tolerability. The investigation was carried out as a randomized,
controlled double-blind phase IV study of parallel group design with 300 pa
tients during 14 days. In the first five days, one group was given one puff
(0.14 mg) of azelastine nasal spray twice daily and one 2 mg tablet of aze
lastine at night. The other group received nasal spray and a placebo tablet
. Beginning on day six, both groups received nasal spray only. Both treatme
nts proved to be effective; The combination therapy, however, was significa
ntly more effective beginning as early as the first treatment. The superior
ity of the combination therapy increased until day five. Thereafter, the tw
o curves grew closer together; however, the superiority of the combination
treatment remained. The tolerability of both treatments was similar.