A double-blind, placebo-controlled evaluation of (dl)-3,7-dihydro-1,8-dimethyl-3-(2-methylbutyl)-1H-purine-2,6-dione in exercise-induced bronchospasm.
The investigational drug, (dl)-3, 7-dihydro-1, 8-dimethyl-3-(2-methylbutyl)-1 H-purine-2, 6-dione, has been proven to be an active bronchodilator and antiallergic compound in animal and clinical studies. Adult asthmatic patients who demonstrated greater than or equal to 20% improvement in FEV1 after inhalation of aerosolized isoproterenol or its equivalent and greater than or equal to 20% reduction in FEV1 after a graded treadmill exercise received theophylline (3, 6 mg/Kg, every 6 h) for 4 days. Further selection of patients was made by demonstrating that theophylline effectively blocked exercise-induced reduction in FEV1 and was effective in increasing FEV1 by 20% when measured 2 h after oral administration. Thus, these adult asthmatics entered a double-blind, placebo-controlled, two-dose cross-over study with the investigational drug at dosage 0.075 mg/kg twice daily and 0.125 mg/kg twice daily. At both dosages studied the investigational drug was found to be an effective bronchodilator in blocking exercise-induced reduction in FEV1 by improving asthma disability scores and increasing FEV1 2 h after oral administration. The incidence and severity of the side effects observed were less than those observed with theophylline.
D000328:Adult; D001249:Asthma / Q000188:drug therapy*; D001250:Asthma, Exercise-Induced / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D008297:Male; D008875:Middle Aged; D013806:Theophylline / Q000031:analogs & derivatives* / Q000627:therapeutic use
D001993:Bronchodilator Agents; C030126:verofylline; D013806:Theophylline