Azelastine in the prophylactic treatment of bronchial asthma: an Italian multicentre comparison with ketotifen
Ambrosi, L.; Bariffi, F.; Carino, M.; Catena, E.; Ceccarelli, G.; Ciampini, M.; Condoluci, M.; Crimi, N.; Ferretti, G.; Gambaro, G.
Journal of International Medical Research 17(3): 218-225
1989
ISSN/ISBN: 0300-0605 PMID: 2569993 Document Number: 327005
The prophylactic effectiveness of the phthalazinone derivative, azelastine was compared with ketotifen. A total of 111 patients, aged 18-65 years, from 10 centres was entered into this randomized, double-blind study. All patients had reversible asthma. After 1 week on placebo, patients were allocated to either8 mg/day azelastine once or twice daily, or to 1 mg ketotifen, twice daily, for a further 12 weeks. Azelastine was more effective in improving respiratory function (forced expiratory flow in 1 s and peak expiratory flow rate) when given in the once daily regimen, whereas clinical measures (number of weekly asthma attacks) were most improved by twice daily dosing. There was no significant difference between the effectiveness of azelastine and that of ketotifen. Treatments were equally well tolerated and a low incidence of side-effects was reported. In conclusion, 8 mg/day azelastine, in either a single or twice daily dosage regimen may be regarded as providing effective prophylaxis against bronchial asthma.