Clinical study of a new orally active chromone in asthma-proxicromil (FPL 57787).
The efficacy and safety of a new orally-active chromone, proxicromil, has been assessed in a single-blind controlled study in perennial extrinsic asthma. Patients entered into the study were currently requiring treatment with sodium cromoglycate (Intal; Lomudal) which was confirmed by deterioration of their asthma when changed to a placebo preparation of identical appearance. Proxicromil was administered for two consecutive 3-week periods using a dosage regimen of 18 mg twice per day for the first period followed by 18 mg four times per day for the second period. Patients improved during the 6 weeks' treatment with proxicromil. This improvement could be detected by the majority of patients by the end of the first week. When patient treatment was changed to a corresponding placebo for a final period of three weeks their asthma deteriorated. No abnormal laboratory findings of significance were detected on haematological, liver function or urinalysis examination. The side effects noted relate mainly to gastro-intestinal disturbances and generally were of a mild nature.
D000293:Adolescent; D000328:Adult; D001249:Asthma / Q000188:drug therapy*; D002867:Chromones / Q000009:adverse effects / Q000627:therapeutic use*; D004205:Cromolyn Sodium / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D010366:Peak Expiratory Flow Rate; D010919:Placebos
D002867:Chromones; D010919:Placebos; C020486:proxicromil; D004205:Cromolyn Sodium