Zaditen® SRO® Permits Once-Daily Dosing with Superior Efficacy in the Prophylaxis of Asthma

This international, multicenter clinical trial was designed to compare the efficacy and safety of two different formulations of ketotifen: Zaditen® SRO® and Zaditen® Standard Form. In a randomized double-blind study over a 12-week treatment period, 3 parallel groups of asthmatic subjects received Zaditen® SRO® (2 mg once daily), Zaditen® SRO® (4 mg once daily), or Zaditen® Standard Form (1 mg twice daily). Asthmatic subjects (362 evaluable cases, aged 6-29 years) kept daily records of clinical symptoms, use of concomitant medication, and peak flow recordings and were examined at 2-week intervals up to the end of the study. Zaditen® SRO® 4 mg administered once a day at night showed a statistically significant faster onset of action and was more clinically effective than Zaditen® Standard Form. The Zaditen® SRO® 4-mg and 2-mg formulations were at least as well tolerated as the standard form, with somnolence occurring equally after both formulations. In conclusion, Zaditen® SRO® (4 mg once daily) was found t...