Open study to establish the efficacy and tolerance of detotifen in the prophylactic treatment of bronchial asthma - abstract

ABSTRACT

Seventeen hospital outpatients with extrinsic bronchial asthma were treated with 1 mg ketotifen for sixteen weeks. The evaluation of overall efficacy was based on five clinical examinations on each patient, including lung function studies, frequency of symptoms and decrease in concomitant drug utilization. The tolerance of the drug and periodic assessment of adverse reactions were also evaluated. Both peak flow and FEV1 showed a progressive increase over four months of treatment with ketotifen. Peak flow increased from an initial value of 225ñ89 1/min. (mean ñ SD) to 303 ñ 122 1/min. Only the values at the fourth month were statistically significant (p<0.01). FEV1 increased progressively from 1.25 ñ 0.45 litres. Again only the values at the fourth month were significant (p<0.025). There was no increase in FVC or FEV1/FVC, even at the fourth month. A number of subjects appeared to have great difficulty grasping the techniques required to perform pulmonary function tests. There were four subjects whose performance was consistently unsatisfactory (wider inter test variation) and well below the others even when clinically asymptomatic; these subjects' values were consistently less than 200 1/min. (peak flow) and 1 l/sec FEV1). The results of re-analysis excluding these subjects were as follow Both peak flow and FEV1 showed higher values and the differences at the fourth month were greater, reaching a level of p<0.005 for peak flow and p<0.01 for FEV1. Ketotifen was beneficial in reducing the frequency of attacks in 14 out of 17 patients. It was very effective in two patients (not a single attack after starting the trial); nine patients did not have any attacks after 12 weeks. No concomitant medication was used by two patients, while seven have considerably reduced the doses of concomitant medication. One patient showed no response. Tolerance was good in all patients, the only side effect being mild daytime sedation in twelve patients. Cessation of therapy was not warranted in any patient because of this side effect. These results suggest that improvement with ketotifen is most marked after three months of therapy (AU)