Ambroxol for the Prevention of Chronic Bronchitis Exacerbations: Long-Term Multicenter Trial

Abstract

In a 6-month, double-blind multicenter trial conducted over the winter, the effects of daily administration of ambroxol retard (75 mg) were compared with those of placebo in preventing exacerbations and improving symptoms and clinical signs in chronic bronchitis patients. The trial was completed by 110 patients in the ambroxol group and by 104 in the placebo group. Initially, there were no significant differences between the groups. By the end of the 2nd month of treatment, 67.2% of the ambroxol group had had no exacerbations compared to 50.4% in the placebo group. At the end of the 6-month trial, 45.5% of the treatment group had had no exacerbations, compared to only 14.4% of the control group. These differences were statistically significant. Patients in the treatment group lost significantly fewer days through illness (442) and had fewer days when they needed antibiotic therapy (371) compared to the placebo group patients (837 and 781). Ambroxol also produced statistically significant symptomatic improvement, measured as difficulty in expectoration, coughing, presence of dyspnea and the auscultatory signs as compared to controls. Since ambroxol was well tolerated and compliance was good, it appears like a drug of choice for pharmacological prophylaxis of chronic bronchitis.

Characterization of differential patient profiles and therapeutic responses of pharmacy customers for four ambroxol formulations

“…While many of the clinical studies demonstrating the efficacy and tolerability of ambroxol have been generated prior to the introduction of Good Clinical Practice, a recent review has identified 92 clinical studies of acceptable quality [4]. Randomized, placebo-controlled short-term (up to 2 weeks of treatment) studies showed efficacy against endpoints such as ease of expectoration, phlegm loosening, sputum volume and sputum viscosity [11–13]. Moreover, more recent studies have demonstrated the efficacy of ambroxol lozenges in the treatment of sore throat [14].…”

Mucoactive therapy in COPD

“…BABOLINI [28] ALLEGRA [43] BORGIA [29] BOMAN [30] JACKSON [31] GRILLAGE [32] MCGAVIN [33] CREMONINI [35] CASTIGLIONI [36] OLIVIERI [37] RASMUSSEN [39] GRASSI [27] GRASSI [41] HANSEN [42] PELA [45] MEISTER [34] MEISTER [46] MALERBA [47] MORETTI [48] NOWAK [44] Total (95% CI) There is accumulating evidence that oxidative stress may play an important role in the pathogenesis of COPD. This is supported by enhanced exhalation of hydrogen peroxide [13], nitric oxide [16], ethane [17], carbon monoxide [16] and isoprostane [12,15], increased concentrations of 4-hydroxyl-2-nonenal in the lungs [19] or by increased urinary excretion of isoprostane [18].…”

Ambroxol for the prevention of acute upper respiratory disease

“…The risk of infection can be reduced by clearing the bronchial tree [1]. Ambroxol is thought to be useful for this purpose.…”

“…Ambroxol is thought to be useful for this purpose. Clinical studies of this drug have shown that it significantly improves the coughing and sputum production of patients with chronic bronchitis [1,2]. Mucoactive drugs such as ambroxol and carbocisteine have numerous pharmacological activities that inhibit bronchial secretion, including direct mucoregulatory effects on gland cells and mucociliary clearance, which are responsible for their clinical efficacy.…”