Double-blind study of ipratropium bromide, a new anticholinergic bronchodilator.

The efficacy and acceptability of ipratropium given by metered-dose inhaler were evaluated in two double-blind crossover tests against placebo, one preceding and one following a 2-wk period of continual open-label ipratropium treatment. Ten patients with chronic bronchitis and 10 with bronchial asthma participated. Ipratropium produced increase in FEV 1 of more than 15% within 5 min of inhalation, and this effect was maintained for 4 to 5 hr. Statistically significant mean increases over the FEV 1 baseline values were recorded after ipratropium treatment in both the initial and the final crossover tests. There were no adverse reactions to any of the placebo or ipratropium test doses or to the ipratropium treatment. Serial electrocardiograms, laboratory tests, blood pressure, and pulse rate showed no change from lthe baseline. Sputum volume and dry-weight determinations in the patients with bronchitis before and after the 14-day treatment revealed no changes.