Ketotifen in the prophylaxis of extrinsic bronchial asthma. A multicenter controlled double-blind study with a modified-release formulation.

In a placebo controlled double-blind multicenter trial, 245 patients with bronchial asthma (131 male and 124 female patients) between 6 and 51 years of age were treated in two parallel groups. A slow-release oral formulation containing 2 mg of ketotifen or placebo was administered daily for a duration of 12 weeks. Over a period of four weeks before the study, 94 percent of the patients had asthmatic attacks. 78 percent had cough, and 62 percent had nasal symptoms. In the group treated with slow-release oral ketotifen, there were 3.9 asthmatic attacks (range, 0 to 20) per week, and in the placebo group, there were 2.9 (range, 0 to 12) (mean values during four weeks prior to start of treatment). At the end of treatment, asthmatic attacks were significantly reduced in the group treated with slow-release oral ketotifen compared with placebo. Significant reduction was also evident for cough and sputum production, as well as nasal discharge and obstruction; however, slow-release oral ketotifen did not significantly improve pulmonary function indices when compared to placebo. The use of concomitant medication (beta-sympathomimetic drugs) was also significantly reduced in the group receiving slow-release oral ketotifen. The overall efficacy assessed by the investigators was "very good" and "good" in 76 percent of the group receiving slow-release oral ketotifen and 30 percent in the group receiving placebo (p less than 0.001). Tolerability rated by the investigators was "very good" and "good" in 90 percent of the group with slow-release oral ketotifen and in 96 percent of the group with placebo (p less than 0.10). The most frequent side effects were "mild" and "moderate" sedation, sleepiness and drowsiness reported in 44 percent of the patients receiving slow-release oral ketotifen and in 26 percent of the patients receiving placebo. This difference was statistically significant (p less than 0.01).

RCT Entities:   Population Interventions Outcomes