232 patients with acute or chronic respiratory disorders characterized by increased secretion, were included in an open multicentre trial to evaluate the tolerability and the activity of a new molecule with secreto-dynamic action, nesosteine. The drug was administered orally at the dose of 900 mg/day for two consecutive weeks. The incidence of side effects (11.6%) was comparable to that observed in studies carried out on molecules with similar activity. Undesirable reactions were found mainly at the gastrointestinal level. Side effects were slight/moderate in most cases; only 3 patients abandoned treatment. Nesosteine therapeutic activity was highly valid; cough and expectorate were favourably affected by treatment. The drug, by restoring the natural characteristics of excreate viscoelasticity, favored a better mucociliary clearance and a more incisive cough expelling action. The activity/tolerability ratio was judged excellent/good by the investigator in 83% of the patients treated.

01 Jan 1989·International journal of clinical pharmacology research

Rheological profile of nesosteine: a new mucoactive agent.

Article

Author: Castelli, C ; Grasselli, G ; Beghi, G ; Allegra, L ; Braga, P C ; Zheng, Y ; Rampoldi, C ; Ornaghi, A

Nesosteine, a new agent shown to improve physical characteristics of bronchial mucus in animal models, has been studied in chronic bronchitic patients to confirm its effect on viscoelasticity of bronchial secretions. Sputum was collected from hypersecretory bronchitic patients in a stable condition before and after seven days of treatment with nesosteine (900 mg/day) or a placebo. At the end of treatment a significant (p less than 0.05) decrease was found in the viscosity in the nesosteine group: on the contrary, a slight, non-significant increase in viscosity was observed in the mucus samples of the placebo group. The improvement in rheological characteristics of the bronchial mucus in the patients treated with nesosteine was associated with an increase in mucus transport rate (mucociliary clearance) observed in the same samples. The findings indicate that nesosteine reduces mucus viscosity in chronic bronchitic patients and that this change induces also an improvement in mucociliary clearance.

01 Jan 1989·Journal of Chromatography B: Biomedical Sciences and Applications

High-performance liquid chromatographic assay of nesosteine in human plasma and urine

Article

Author: Loredana Loschi ; Maria Angela Girometta ; Paolo Ventura

A high-performance liquid chromatographic method for the quantitation of the mucoactive drug sodium 2-(3-thiazolidinylcarbonyl)benzoate in plasma and urine was developed, involving liquid-liquid extraction under acidic conditions and reversed-phase chromatography using ultraviolet detection at 210 or 235 nm. The extraction efficiency, linearity, limit of detection, precision and accuracy were determined. Products of the main biotransformation of the drug, involving hydrolysis of the amidic bond, do not interfere. The method is selective, precise, reproducible and applicable to studies of the pharmacokinetic behaviour of the drug in humans. Pharmacokinetic parameters derived from six healthy subjects following acute intravenous administration of the drug (150 mg) are presented.

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Indication	Highest Phase	Country/Location	Organization	Date
Asthma	NDA/BLA	-	Camillo Corvi	-
Bronchitis	NDA/BLA	-	Camillo Corvi	-

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