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 less than 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 less than 0.001 between treatments).
Constipation and
nausea were reported by 9 patients on
codeine and by no patient on
glaucine (p less than 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codeine was withdrawn from the study after 3 days because of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 less than 0.001); the mean value of the patients' visual analogue scales decreased from 93 mm to 1 mm (p less than 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)