Mucosolvan is a ‘mucus-modifier’ whose active compound is ambroxol. The aim of our research was to determine its clinical efficacy in the treatment of bronchial stasis by carrying out two successive double-blind studies in two parallel groups of patients and comparing ambroxol with placebo in a treatment lasting 10 days. The first trial involving 60 patients daily treated with 120 mg of ambroxol showed significant differences (p < 0.05) in sputum volume, sputum viscosity, difficulty of expectoration, and severity of cough when compared with the placebo group. The two groups of patients were initially well matched and the drug was well tolerated. In a second trial involving 60 new patients daily treated with 30 mg of ambroxol, the drug showed no clear clinical effects. We conclude that ambroxol is an effective ‘mucus modifier’ and is well tolerated at a dose of 120 mg/day.
Fluticasone propionate aqueous spray, a new intranasal corticosteroid preparation, and disodium cromoglycate 2% aqueous nasal spray, an established preventive treatment for seasonal allergic rhinitis, were compared in a double-blind, double-dummy, parallel-group, multicentric study in France. A total of 218 patients with seasonal allergic rhinitis caused by grass pollen (verified by positive skin prick test) were preventively treated before the onset of the grass pollen season with either fluticasone propionate 200 micrograms once daily or disodium cromoglycate 5.2 mg four times daily. Half of these doses was given in each nostril. Treatment started before the onset of the pollen season in most patients (178/218). Diary cards, including symptoms of rhinitis and usage of nasal sprays, were filled in twice daily for 6 weeks. Terfenadine in 60-mg tablets and eye-drops could be used as rescue medications. We treated 110 patients with fluticasone propionate and 108 patients with disodium cromoglycate. Patients treated with fluticasone propionate had significantly more days free of primary efficacy symptoms of sneezing (P < 0.001) and nasal discharge during the day (P = 0.002), as well as free of all the other nasal symptoms (P < 0.01), and significantly lower median scores (P < 0.05) for all nasal symptoms except nasal discharge than patients treated with disodium cromoglycate. There was no difference in eye symptoms or in rescue medication use between the two groups. Compliance with the treatment was assessed.(ABSTRACT TRUNCATED AT 250 WORDS)
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