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At least 19 recordsLinked to original sources

PubMed1987

Ambroxol for the prevention of chronic bronchitis exacerbations: long-term multicenter trial. Protective effect of ambroxol against winter semester exacerbations: a double-blind study versus placebo.

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.

Adult↗

PubMed1988

[Modification of mucociliary clearance by a combination of theophylline with ambroxol and of ambroxol in monotherapy].

Influence on Mucociliary Clearance by a Theophylline-Ambroxol Combination and by Ambroxol in Monotherapy. In a controlled randomised double-blind study the influence of theophylline + ambroxol (TA) and ambroxol (A) on lung function and mucociliary clearance was investigated. 19 patients with chronic obstructive lung disease were treated after a 5-day wash-out period for 5 days with TA (700 mg theophylline, 60 mg ambroxol/d) or A (60 mg ambroxol/d), respectively. Measurements were done on the 5th and 10th day. Under the treatment with TA a marked improvement of lung function was observed. The mucociliary clearance improved under treatment with TA and A, with TA being significantly better compared with treatment group A.

Adult↗

PubMed1992

Inhibitory effect of theophylline, theophylline-7-acetic acid, ambroxol and ambroxol-theophylline-7-acetate on rat lung cAMP phosphodiesterase isoenzymes.

It is assumed that theophylline (THEO) and its xanthinic derivatives inhibit lung phosphodiesterase (PDE) and block adenosine receptors in the induction of bronchodilatation. Since the theophyllinic compound ambroxol-theophylline-7-acetic acid (ATA) has been shown in vivo to be a sound bronchodilator, this paper compares the action of ambroxol-theophylline-7-acetate (ATA), its two components, theophylline-7-acetic acid (TAA) and ambroxol (AMB), and theophylline (THEO) on the hydrolytic activity of three rat-lung cAMP PDE (types I, III and IV) and on striatal adenosine receptors. THEO inhibited all three isoenzymes with equal intensity, whereas ATA was as powerful but inhibited types III and IV only, on which AMB and TAA also showed lower effects. Lastly, unlike THEO, ATA and its two components were unable to antagonize adenosine receptors. Taken as a whole, these results suggest that the bronchodilating activity of ATA is the result of specific inhibition of particular forms of PDE and is thus more specific than that of THEO alone.

3',5'-Cyclic-AMP Phosphodiesterases↗

PubMed1992

A novel pharmacological approach for paraquat poisoning in rat and A549 cell line using ambroxol, a lung surfactant synthesis inducer.

Paraquat (PQ) is a widely used herbicide that causes acute adult respiratory distress syndrome (ARDS) and chronic lung damage (diffuse fibrosis). One of the earliest biochemical effects induced by PQ is damage to type II pneumocytes with consequent depletion of surfactant. With the aim of counteracting the toxic effects of PQ, a series of investigations were performed into the possible protective effect of the drug ambroxol, which induces the synthesis of surfactant in lung alveolar type II cells. The number of survivors and survival time of rats treated ip with 35 mg PQ/kg was significantly increased by 3 days of ambroxol pretreatment and by ambroxol treatment 30 min or 2 hr after PQ. Total phospholipid content in lung and bronchoalveolar lavage fluid (BALF) was significantly reduced 30 hr after treatment with PQ alone. The association of ambroxol with PQ significantly antagonized this reduction. In BALF the ratio between palmitic acid and stearic acid concentrations was significantly lower in animals treated with PQ alone but was returned to normal by the association with ambroxol. The cell line A549, exposed in vitro to PQ concentrations from 0.5 x 10(-4) to 2 x 10(-3) M, showed a significant dose-dependent loss of viability. Cells pretreated with ambroxol (10 mg/ml) were more resistant to PQ and their viability started to decrease significantly only from a PQ concentration of 0.8 x 10(-3) M. Membrane microviscosity was measured on the same cells. Cells treated with PQ alone showed a reduction of membrane microviscosity, which was significantly counteracted by ambroxol pretreatment. The curves of modification of membrane microviscosity of cells treated with PQ and with ambroxol plus PQ paralleled those of cell viability, indicating that the stimulation of surfactant synthesis in vitro may be a prerequisite for counteracting some of the early effects of PQ.

Adenocarcinoma↗

PubMed1991

Characterization of bromhexine and ambroxol in equine urine: effect of furosemide on identification and confirmation.

The purpose of this study was two-fold: (1) to develop a simple and sensitive screening procedure for identifying and confirming bromhexine and ambroxol and, (2) to determine the effect of furosemide on the detection of bromhexine, ambroxol, or their metabolites in urine. Female horses (450-550 kg) treated with bromhexine or ambroxol (1 g, p.o.) were used. Urine samples were collected up to 48 h post-drug administration and analysed. Blind samples were used in evaluating the sensitivity of these methods and reproducibility of the results. Bromhexine and ambroxol were extensively metabolized in the horse. These agents and their respective metabolites were identified and confirmed using thin-layer chromatography (TLC) and gas chromatography-mass spectrometry (GC-MS), respectively. Hydroxy-bromhexine and desmethyl-bromhexine were major metabolites found to be unique to bromhexine-treated horses. These metabolites selectively absent from ambroxol-treated horse urine provide a chemical means to distinguish bromhexine from ambroxol administration in horses. These specific metabolites were similarly identified and confirmed in "blind" horse urine samples. The concomitant presence of furosemide (300 mg, i.v.) with bromhexine or ambroxol did not mask the presence of these agents or alter their metabolite profile. By application of the methods described in this study, bromhexine and ambroxol metabolites in horse urine can be easily identified and confirmed.

Ambroxol↗

PubMed1982

The antenatal use of ambroxol (bromhexine metabolite VIII) to prevent hyaline membrane disease: a controlled double-blind study.

A prospective double-blind clinical trial was carried out to determine whether ambroxol (bromhexine metabolite VIII) treatment (1000 mg/day for a period of 5 days) reduces the risk of hyaline membrane disease (HMD) in potentially premature infants. Amniocentesis was performed before the first and 24 h after the last application of ambroxol or placebo to assess the development of the total phospholipid phosphorus content, the L/S ratio, the P/S ratio, and the properties of the surface tension of the amniotic fluid after ambroxol or placebo. There were 246 infants born to 224 mothers. Of the 116 infants with less than or equal to 36 completed weeks' gestation, 56 were in the ambroxol and 60 in the placebo group. No differences between groups occurred in risk factors for HMD (diabetes, asphyxia, male sex, cesarean section). Statistically significant differences in favor of the infants in the ambroxol group were found in the HMD incidence: 23.2% in the ambroxol group compared with 41.7% in the placebo group (p less than 0.05). There was no reduction of the HMD incidence in the less than or equal to 32-week gestational age category in the ambroxol group compared with the placebo group inspite of the fact that all the examined parameters for determining lung maturity reflected a stimulatory effect of ambroxol compared with the results of the placebo group, particularly before the 33rd week of gestation. Prolonged rupture of the membranes played no protective role against HMD.

Ambroxol↗

PubMed1992

Antenatal ambroxol effects on surfactant pool size and postnatal lung function in preterm ventilated rabbits.

Following maternal treatments with 50 mg/kg/day ambroxol for 2 or 3 days before delivery at 28 days gestation, preterm rabbits were ventilated to evaluate lung function. Subsequently, surfactant saturated phosphatidylcholine (SatPC) pool sizes were measured. One half of the ambroxol treated and control rabbits were given surfactant at delivery. Although surfactant improved lung function comparably for control and ambroxol treated rabbits, ambroxol treatments did not change ventilatory pressure requirements, compliances, or the recovery of intravascular labeled albumin in the lungs. Ambroxol treatments tended to increase lung volumes as evaluated by pressure-volume curves. The ambroxol treatments significantly increased lung tissue SatPC by 22%, but there were no changes in alveolar SatPC pool values. These results do not indicate a large effect of ambroxol on lung function in preterm rabbits.

Ambroxol↗

PubMed1992

[Effects of ambroxol HCl on the guinea pig tracheal mucous secretion and the rat pulmonary surfactant secretion].

The effects of orally administered ambroxol HCl (ambroxol) on guinea pig tracheal mucous secretion and rat pulmonary surfactant secretion were investigated histologically and biochemically. Ambroxol significantly increased the number of active goblet cells in guinea pig tracheal epithelium and total mucopolysaccharide level. Moreover, ambroxol significantly increased the neutral mucopolysaccharide level and PAS-positive substance in the guinea pig tracheal submucosal glands. Ambroxol did not show a significant effect on the content of the total phosphatidylcholine in rat lung lavage fluid, while ambroxol significantly increased the ratio of disaturated phosphatidylcholine to total phosphatidylcholine. From these results, it is suggested that ambroxol increases both the tracheal mucous secretion, especially the neutral mucopolysaccharide, and pulmonary surfactant secretion and these effects reflect part of the expectorant mechanism of the drug.

Ambroxol↗

PubMed1989

Failure of ambroxol to influence the allergen induced bronchial constriction in sensitized guinea pigs.

The action of ambroxol was tested in an in vivo guinea pig asthma model. Ambroxol, a compound with antiallergic properties effects the mediator releasing cells in vitro and surfactant secretion from alveolar type II cells. This paper deals with the action of ambroxol in an in vivo asthma model in guinea pigs. Ovalbumin sensitized guinea pigs were artificially ventilated by negative chest wall pressure, using a tank respirator. Breathing parameters were measured pneumotachographically. The experimental animals were treated with 50 mg/kg ambroxol i.p. for 5 days; control animals received saline only. The results indicate that pretreatment with ambroxol had no significant effect on the allergic bronchial constriction, while in vitro ambroxol effects on mediator releasing cells and surfactant production point to antiallergic properties. An explanation of the failure of allergenic preventing effects of ambroxol in vivo may be its insufficient concentration in the tissue.

Allergens↗

PubMed1989

Ambroxol for prevention and treatment of hyaline membrane disease.

To estimate the efficacy of ambroxol for clinical use in prenatal prevention and postnatal therapy of hyaline membrane disease (HMD) all available experimental and clinical data were reviewed. The administration of ambroxol in animals has a certain promoting influence on lung maturation, a high specificity to lung tissue and a favourable relationship between intended action and negative adverse effects. In clinical studies concerning the prevention of HMD, ambroxol increases the values of amniotic fluid parameters used for estimation of lung maturity and reduces the incidence of HMD at least as effectively as corticosteroids. The number of infants at less than 33 gestational weeks in these reports is small, and further studies will have to confirm the results. Ambroxol applied postnatally has beneficial effects on the course of severe HMD by increasing survival rate, by decreasing duration of oxygen need and artificial ventilation and by improving compliance. Pharmacological studies in preterm HMD-infants showed no influence of ambroxol on blood pressure and heart rate. In 3 of 8 newborns a transient increase of transcutaneous oxygen tension was seen during infusion of ambroxol. Ambroxol is quickly bound to tissue receptors which release it continuously indicating that repeated applications are as effective as continuous infusion.

Adrenal Cortex Hormones↗

PubMed1992

Randomized double blind trial of Ambroxol for the treatment of respiratory distress syndrome.

In order to test the ability of Ambroxol to improve the clinical course of respiratory distress syndrome and to reduce the incidence of complications a multicentre, randomized, placebo-controlled double-blind trial was conducted. Entry was limited to infants with a birth weight below 1500 g. A total of 179 neonates were enrolled, but 31 were later excluded because they had other diseases. Of the remaining 148 babies, 74 received Ambroxol (birth weight 1190 +/- 216 g; gestational age 29.1 +/- 1.9 weeks) and 74 placebo (birth weight 1168 +/- 216 g; gestational age 28.9 +/- 1.9 weeks). In the Ambroxol group 23 (31%) and in the placebo group 27 (37%) infants died during the first 5 months of life. In 28 day-survivors Ambroxol was able to significantly improve the PaO2/FiO2 ratio, mean airway pressure, phospholipid profile of tracheal effluent and pulmonary mechanics of spontaneously breathing infants. In addition, the incidences of bronchopulmonary dysplasia (29% vs 54%), intraventricular haemorrhage (25% vs 44%) and postnatally acquired pneumonia (15% vs 36%) were significantly reduced in the Ambroxol group as compared to the control group. No adverse events attributed to the Ambroxol treatment were reported.

Ambroxol↗

PubMed1991

Prevention by ambroxol of bronchopulmonary complications after upper abdominal surgery: double-blind Italian multicenter clinical study versus placebo.

A double-blind multicenter study was carried out to evaluate the effectiveness of ambroxol, a drug able to promote surfactant synthesis, in the prevention of postoperative bronchopulmonary complications. A total of 252 patients with chronic obstructive lung disease (COLD) undergoing upper abdominal surgery were randomly allocated to receive either 1 g/day of ambroxol intravenously for 6 consecutive days in the perioperative period or placebo. Pulmonary complications were evaluated by clinical studies, radiographic, and blood gas analysis. There was a significant difference in atelectasis between the 2 groups (10.6% ambroxol vs 23.9% placebo). In addition, analysis of variance showed that the PaO2 values of the ambroxol-treated group after surgery decreased less than those of the placebo-treated group (p less than 0.05) from the preoperative values. The treatment was well tolerated, although nausea was significantly more frequent in the ambroxol-treated group. We think that ambroxol should be considered as an alternative and new pharmacologic approach for the prevention of postoperative pulmonary complications.

Adult↗

PubMed1987

[Induction of fetal lung maturation using ambroxol and betamethasone. Results of an open multicenter study].

In a randomized open multicenter study the results of antenatal prophylaxis against neonatal RDS by administration of betamethasone were compared with those obtained with the bromhexine VIII metabolite Ambroxol. Ambroxol was administered for a maximum of 5 days - 1000 mg in an infusion solution; betamethasone was injected intramuscularly in 2 daily doses of 8 mg. One of these two substances was given to 123 pregnant women for pulmonary maturation in the fetus, in accordance with a randomization plan. The patients were either being treated for premature labor or pregnancy was terminated on the basis of indication between the 28th and 36th week. Therapy had to be discontinued in 4 cases in each group, because of continued labor and birth, and in one case because of an amniotic infection syndrome. A full analysis of the treatment records of 57 pregnancies in the Ambroxol group was carried out; the corresponding figure for the betamethasone group was 58. In 39 patients the duration of pregnancy was 37 weeks or more, so that no assessment on the basis of neonatal pulmonary maturity was possible. In the remaining pregnancies, RDS morbidity was estimated on the basis of clinical and radiological findings and blood gas analysis. Related to a maximum duration of pregnancy of 34 weeks, RDS morbidity after Ambroxol therapy was 18.2% (2 out of 11), as opposed to 35.7% (5 out of 14) after betamethasone treatment. The results confirm that antenatal administration of Ambroxol can bring about a reduction in neonatal RDS corresponding to that achieved with betamethasone therapy. However, with Ambroxol the occurrence of side-effects is potentially lower; it therefore has advantages over betamethasone while being equally efficacious.

Ambroxol↗

PubMed1987

An alternative to steroids for prevention of respiratory distress syndrome (RDS): multicenter controlled study to compare ambroxol and betamethasone.

The results are reported of a multicenter randomized study of the effectiveness of maternal administration of betamethasone versus ambroxol, a substance of the group of the benzylamines, for prevention of RDS in preterm infants. Women of 27 to 34 weeks gestation with threatened premature delivery or planned premature delivery were admitted to the trial. Between September 1981 and November 1984 a total of 288 randomized patients delivered 315 neonates. The incidence of RDS was assessed in 169 viable neonates born before the 37th week. Of these 86 were born of 76 mothers treated with beta-methasone and 83 of 76 mothers treated with ambroxol. The overall incidence of RDS was significantly (P less than 0.05) higher in the betamethasone group (31%) than the ambroxol group (13%). Ambroxol was significantly more effective than betamethasone in twin births, in infants born before the 31st week, when ROM to delivery time was more than 48 hours, when treatment to delivery time was between 2 and 7 days and in female infants. The neonatal infection rate was significantly higher (P less than 0.05) in the group of betamethasone treated infants (18% with four fatalities) than in the group of ambroxol treated infants (9% with one fatality). These results suggest that ambroxol may be a valid alternative to steroids for prevention of RDS.

Ambroxol↗

PubMed1990

[Ambroxol versus betamethasone for the promotion of antepartum lung maturity in pathological pregnancies].

Although glucocorticoids have been universally implemented to stimulate fetal lung maturity, their effectiveness and side effects are still widely contested. In search of alternative drugs a double-blind study was conducted between June 1981 and June 1984 comparing betamethasone, a conventional corticoid, and ambroxol, a bromhexine metabolite for efficacy and tolerance in prenatal prevention of the respiratory distress syndrome (RDS) in premature infants and full-term neonates. The therapeutic efficacies of betamethasone and ambroxol for this indication proved to be comparable. Since the possible risks of corticoid therapy in abnormal pregnancies are repeatedly discussed in the literature and in daily clinical practice. 137 patients with EPH gestosis, placental insufficiency, diabetes mellitus, and premature rupture of the membranes were selected from the original group of 308 patients. Only minor side effects (e.g. nausea) were present in a few of the 137 cases undergoing treatment with the 2 test substances. No side effects were observed in the neonates. The incidence of fetal RDS was comparable in both groups (2.9% with ambroxol, 2.2% with betamethasone). Transient and mild RDS cases were slightly more frequent in the ambroxol group than in the betamethasone group. To date, contraindications to ambroxol treatment in abnormal pregnancies are unknown and since generally the rate of potential side effects is considered to be lower in comparison with corticoid treatment, the use of ambroxol especially in abnormal pregnancies corresponding indication can be recommended.

Ambroxol↗

PubMed1989

Steady-state bioavailability and pharmacokinetics of ambroxol and clenbuterol administered alone and combined in a new oral formulation.

Ambroxol and clenbuterol are two drugs with potential pharmacological synergy. The objective of this study was to compare the apparent bioavailabilities at steady-state of these two compounds administered alone or in combination (CHF-023). Nine healthy male volunteers participated in the study. They received 30 mg of ambroxol alone (one Fluibron tablet), or 20 micrograms of clenbuterol alone (one Spiropent tablet), or 30 mg of ambroxol plus 20 micrograms of clenbuterol in combination (one CHF-023 tablet), every 12 hours for 7 days on three separate occasions. Ambroxol and clenbuterol concentrations were measured in plasma by appropriate GC/MS methods. Pharmacokinetic parameters were calculated by non-compartmental methods and submitted to statistical comparisons. Compartmental analysis was also performed on data provided by CHF-023 treatment. It was concluded that apparent bioavailabilities of ambroxol and clenbuterol are almost identical in Fluibron and CHF-023 tablets, and in Spiropent and CHF-023 tablets, respectively, with no statistically significant differences between pharmacokinetic parameters calculated for these two drugs during different treatments, except for peak concentration of ambroxol.

Administration, Oral↗

PubMed1986

Ambroxol decreases bronchial hyperreactivity.

Ambroxol is a new compound which increases secretion of phosphatidylcholine by type II pneumocytes. The secretion of phosphatidylcholine could affect bronchial hyperreactivity in two ways: by increasing lysophosphatidylcholine turnover and/or by modifying the layer of bronchial secretion that covers airway receptors. To see whether ambroxol affects bronchial hyperreactivity, we carried out a double-blind cross-over study, evaluating the efficacy of this drug vs placebo in modifying methacholine PD20 in 11 asthmatic patients, 4 atopics and 7 non-atopics. 90 mg of ambroxol or placebo were randomly administered orally for one of two 14-day periods. Methacholine PD20 was evaluated before and after each treatment. A highly significant difference was demonstrated in the direct comparison between ambroxol and placebo as to their ability to modify mean metacholine PD20, which with ambroxol was more than double that with placebo. It was also seen that ambroxol induced a significant increase in baseline values of PD20, i.e. a significant decrease in bronchial hyperreactivity. Placebo did not do this.

Adult↗

PubMed1995

Use of ambroxol and bromhexine as mucolytics for enhanced diffusion of furaltadone into tracheobronchial secretions in broilers.

1. Ambroxol and bromhexine were evaluated as mucolytics and to enhance the passage of furaltadone into tracheobronchial secretions (TBS) in chronic complicated respiratory disease-affected broilers. 2. Viscosity of TBS was noticeably increased in the ambroxol-treated birds and only slightly increased in the bromhexine groups; however, the physical (nature) of TBS was superior in the ambroxol-treated broilers. 3. There was a clear increase in the passage of furaltadone into tracheobronchial secretions only in the ambroxol-treated birds. 4. Everyday use of ambroxol in broilers is discussed.

Ambroxol↗