Comparison of the bronchodilatory action and side-effects of ipratropium bromide and thiazinamium methyl sulphate: a long-term, double-blind, crossover trial in patients with chronic bronchitis.
A long-term, double-blind study was carried out in 12 male chronic bronchitics with partially reversible airways obstruction to compare the bronchodilatory effects of ipratropium bromide and thiazinamium methyl sulphate and their influence on micturition and visual accommodation. Patients received either ipratropium bromide (160 micrograms daily) by aerosol plus placebo tablets or thiazinamium methyl sulphate tablets (900 mg daily) plus placebo aerosol for 10 weeks. After a 1-week treatment-free period, patients were crossed over to the alternative medication for a further 10 weeks. Measurements were made before and 1 and 10 weeks after the beginning of each treatment period. The bronchodilatory responses were measured by spirometry (VC and FEV1) and maximal expiratory flow volume (MEFV) curves (FVC, PEF, MEF50 and MEF25). Micturition was estimated from a mictiogram, obtained with a system based on an ultrasonic principle. Subjective clinical findings, heart rate and blood pressure were also obtained. The variables from both the spirometric and MEFV measurements showed the bronchodilatory effect of ipratropium bromide to be superior to that of thiazinamium methyl sulphate. Because the largest differences were found in the variables from the effort-dependent, first part of the forced expiration (PEF and FEV1), the results suggest a difference in effect occurring mainly in central and higher airways. Only the MEF25 value after 10-weeks' treatment was lower in the ipratropium bromide period with respect to the thiazinamium methyl sulphate period, but not significantly so. Although 3 patients on thiazinamium had visual complaints no objective disturbances of micturition or accommodation were established.
D001286:Atropine Derivatives / Q000627:therapeutic use*; D001991:Bronchitis / Q000188:drug therapy*; D002908:Chronic Disease; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D006801:Humans; D009241:Ipratropium / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011398:Promethazine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*
D001286:Atropine Derivatives; D011398:Promethazine; D009241:Ipratropium