Efficacy and tolerability of glaucine as an antitussive agent

Summary

One hundred and thirty out-patients, affected by acute and chronic cough caused by upper respiratory tract inflammation, took part in two clinical studies aimed at evaluating the efficacy and tolerability of glaucine, a new antitussive agent. The first study involved 90 patients in a double-blind comparative trial of glaucine and codeine: both treatments were administered as a syrup at a dosage of 30 mg 3-times daily for 7 days. The cough suppressant effect of the two treatments was checked by the physician and the patient using a 4-point scale (from absent to severe), and by the patient using a visual analogue scale. Mean scores of the physician's evaluation decreased from 3.0 to 1.10 after codeine and from 3.0 to 0.47 after glaucine (p<0.001 between treatments). Mean values of the patients' visual analogue scales decreased from 83 mm to 17 mm after codeine, and from 85 mm to 7 mm after glaucine (p<0.001 between treatments). Constipation and nausea were reported by 9patients on codeine and by no patient on glaucine (p<0.01). One patient on codeine was withdrawn from the study after 3 days because of vomiting, constipation and nausea. The second study was an open trial in 40 patients who received glaucine capsules at a dosage of 30 mg 3-times daily for 28 days. The antitussive effect of the treatment was evaluated on the basis of the same criteria as in the first study. The mean score of the physician's evaluation decreased from 3.0 to 0.15 (p<0.001); the mean value of the patients' visual analogue scales decreased from 93 mm to 1 mm (p<0.001). Mild constipation was reported by 5 patients at the end of the 4-week treatment period. It is concluded that, under the conditions of these studies, glaucine is more effective and better tolerated than codeine.

Key Words::

• Glaucine
• codeine
• antitussive agents
• cough