Azelastine in the prophylactic treatment of bronchial asthma: an Italian multicentre comparison with ketotifen.

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 either 8 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.
AuthorsL Ambrosi, F Bariffi, M Carino, E Catena, G Ceccarelli, M Ciampini, M Condoluci, N Crimi, G Ferretti, G Gambaro
JournalThe Journal of international medical research (J Int Med Res) 1989 May-Jun Vol. 17 Issue 3 Pg. 218-25 ISSN: 0300-0605 [Print] England
PMID2569993 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • Histamine H1 Antagonists
  • Phthalazines
  • Pyridazines
  • Ketotifen
  • azelastine
  • Adult
  • Asthma (drug therapy, prevention & control)
  • Clinical Trials as Topic
  • Histamine H1 Antagonists (therapeutic use)
  • Humans
  • Italy
  • Ketotifen (adverse effects, therapeutic use)
  • Middle Aged
  • Multicenter Studies as Topic
  • Phthalazines (adverse effects, therapeutic use)
  • Pyridazines (therapeutic use)

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