Therapeutic equivalence of a fenoterol/ipratropium bromide combination (Berodual) inhaled as a dry powder and by metered dose inhaler in chronic obstructive airway disease.

A randomized double-blind cross-over study was performed to compare the bronchodilator effects of a fenoterol/ipratropium bromide combination (Berodual) when inhaled as a dry powder and by metered dose inhaler (MDI) in an equal doses (fenoterol 100 micrograms + ipratropium bromide 40 micrograms). Thirty-eight patients (29 male, 9 female, mean age 53 years) with reversible chronic obstructive airway disease were studied on 2 separate days by employing the double-dummy technique. The effects of the two modes of administration of the fixed combination were followed by pulmonary function tests [forced expiratory volume (FEV1), forced vital capacity (FVC)] from 15 min up to 6 h after administration. In addition, the pulse rate was recorded just before each pulmonary function test. The FEV1 and FVC time-response curves showed that the dry powder had an overall efficacy profile similar to MDI. Both formulations produced clinically significant improvements in FEV1 in approximately 10 min. Peak effects occurred in 1 h while at 6 h after test drug inhalation there was still an increase in FEV1 of 14%. No safety problems were observed after the use of the test drugs and no clinically significant changes in pulse rate were found. It is concluded that the dry powder of the fenoterol/ipratropium bromide combination provided effective bronchodilation of similar degree and duration to that achieved with the MDI. It would appear, therefore, to be a valuable alternative to MDI.

A double-blind comparison of low-dose ofloxacin and amoxycillin/clavulanic acid in acute exacerbations of chronic bronchitis.

The efficacy and safety of ofloxacin 400 mg once daily and amoxycillin/clavulanic acid 500/125 mg three times daily were compared in a double-blind manner in patients with an acute exacerbation of chronic bronchitis. Of 102 patients enrolled, 95 (93%) could be assessed for effectiveness. Treatment success was achieved in 41 (84%) of 49 patients in the ofloxacin group compared with 41 (89%) of 46 patients in the amoxycillin/clavulanic acid group. One patient who received ofloxacin and four patients in the amoxycillin/clavulanic acid group stopped medication because of unacceptable side effects. Microbiological results were evaluable in 47% of the patients. Predominant initial pathogens were Haemophilus influenzae, Streptococcus pneumoniae, sometimes in combination, and less frequently Branhamella catarrhalis. In two patients with clinical failure, randomized to ofloxacin, the initial pneumococcal strains persisted in the sputum after treatment.

Cefixime versus amoxicillin/clavulanic acid in lower respiratory tract infections.

Sixty patients with lower respiratory tract infections, mainly acute bronchitis were treated for 14 days with either cefixime 200 mg twice daily (plus placebo once daily) or amoxicillin/clavulanic acid 500 mg/125 mg thrice daily in a double-blind manner. The sputum cultures indicated that all isolated pathogens (notably Hemophilus species, S. pneumoniae and B. catarrhalis, including the beta-lactamase producing species) were sensitive to cefixime, with the exception of Pseudomonas species. The bacteriological eradication rates were 54% and 52% for cefixime and amoxicillin/clavulanic acid, respectively. The positive clinical response (cured or improved) was 71% for the cefixime treated group and 74% in the amoxicillin/clavulanic acid group. There were no side effects and no significant adverse laboratory changes in both groups. The results indicate that cefixime twice daily is comparable in safety and efficacy with amoxicillin/clavulanic acid, thrice daily in acute bronchitis.

Clinical evaluation of cefotiam and cefamandole in respiratory tract infections.

Eighty-two adult hospitalized patients suffering from respiratory tract infections were treated with cefotiam or cefamandole in an open comparative study. The patients were allocated randomly to one of the two treatments. The recommended dosage regimens (i.m. or i.v.) were used for both groups (cefotiam 1 g b.i.d., cefamandole 1 g t.i.d.). The duration of treatment was 7 to 14 days according to the response of the disease condition. 80 patients were analyzed. The tolerability of both drugs was good and comparable. The clinical and bacteriological efficacy of both drugs was equivalent. The radiological examinations showed a better improvement of the patients treated with cefotiam.

Primary pulmonary amyloidosis.

A 51-year-old man with amyloidosis of the lungs, skin and testes, is described. For 7 years, there was an unusually slow progression of the disease and - compared to the literature - an uncommonly long survival.

Pleuropulmonary involvement in Waldenström's Macroglobulinaemia. Case report.

Pleuropulmonary involvement secondary to Waldenström's macroglobulinaemia is described from a 70-year-old male. The radiographic abnormalities were unilateral pleural effusion and infiltration of the left lower lobe. There were no respiratory symptoms. After removal of the pleural fluid no other therapy was applied.

Cefotaxime in the treatment of lower respiratory tract infections.

The effect of cefotaxime in treatment of lower respiratory tract infections was evaluated in 23 patients. Because of its high efficacy, low potential for adverse reactions, and convenient dosage, cefotaxime was found to be an effective antibacterial choice in the treatment of this troublesome condition.

Long-term treatment of bronchial asthma with pirbuterol aerosol.

In an open study in which 25 male outpatients with chronic obstructive pulmonary disease received pirbuterol aerosol for up to 14 months bronchodilator efficacy was maintained throughout. There were no serious side effects, and laboratory abnormalities were of little clinical relevance. Sinus bradycardia was the most frequently observed ECG change.

Pirbuterol versus orciprenaline aerosols in the treatment of bronchial asthma.

In a multiple-dose, double-blind parallel group study two groups of 19 male outpatients each with chronic pulmonary obstructive disease received either pirbuterol aerosol (0.4 mg) or orciprenaline aerosol (1.3 mg) 3--4 times daily for 12 weeks (after about 1 week of placebo administration). Bronchodilator efficacy persisted throughout the treatment period. However, the initial (week 0) response to pirbuterol, but not orciprenaline, tended to be greater than responses on subsequent test days. Side effects, changes in blood pressure or pulse rate, and clinical chemical abnormalities were of minor clinical importance, but post-inhalation dysrhythmias were seen in four patients receiving orciprenaline. In both treatment groups, some patients showed prolongation in bleeding and/or clotting times.

Oral cefaclor for treatment of bronchitis--a comparative double-blind study versus amoxycillin.

Either 500 mg cefaclor or amoxycillin was administered at random thrice daily to 50 adult outpatients with acute or acute-to-chronic bronchitis. A total of 31 pathogens were isolated from sputum, mostly Streptococcus pneumoniae [17] or Haemophilus influenzae [3], or both [2]. All pathogens but one were susceptible to cefaclor; all but six were susceptible to amoxycillin. Satisfactory clinical results were obtained in 62.5% of the patients treated with cefaclor and 66% of the patients treated with amoxycillin.

Oxytropium bromide in bronchial asthma: comparison of metered dose inhaler and powder inhalation of the anticholinergic bronchodilator oxytropium bromide in protection against acetylcholine and histamine provocation.

A marked protective effect of 0.2 mg oxytropium bromide (Ba 253), administered by inhalation, was observed against experimental provocation with a 3% acetylcholine solution. There is no difference between application by means of a metered dose inhaler or by means of powder inhalation. There is no marked protective effect of 0.2 mg oxytropium bromide administered by inhalation (aerosol or powder) against experimental provocation with a 0.3% histamine solution.

Comparative investigations on pirbuterol, salbutamol and placebo aerosols in bronchial asthma.

In a single blind crossover study 12 asthmatics received in randomised order single doses of pirbuterol (200 and 400 microgram), salbutamol (200 microgram) and placebo-aerosols, in order to determine the extent and duration of bronchodilator activity, the optimum dosage, the incidence, type and degree of side effects and the cardiovascular as well as hematologic, renal and hepatic functions after inhalative administration. All patients were checked by repeated pulmonary function studies, ECG and extensive laboratory tests. No significant differences were found between salbutamol 200 microgram and pirbuterol 400 microgram when lung functions were studied over 4 hr following inhalation. Pirbuterol 400 microgram and salbutamol 200 microgram were significantly better than pirbuterol 200 microgram. There were no side effects or changes of clinical relevance in pulse rate, blood pressure, ECG or laboratory test results. Pirbuterol is a well tolerated bronchodilator which appears to be of clinical importance in inhalative treatment of bronchospastic disease.

Bronchial reactivity in asthma to inhaled histamine during treatment with ketotifen.

A 12-week open trial using varying dosages of ketotifen, an oral drug with a prophylactic anti-asthmatic effect, was carried out in 20 patients with stable chronic bronchial asthma (age 20--50 years, no steroid treatment) to determine whether the frequency of asthma attacks and bronchodilator consumption could be reduced, and whether pulmonary function would improve. The protective action of ketoifen against a histamine inhalation test was measured at the beginning of the trial and at regular intervals during the trial. The patients experienced a significant improvement in their asthma and a significant decrease in the number of asthma attacks during the trial. Concomitantly, the need for other anti-asthma agents was reduced. Pulmonary function tests improved before and following histamine inhalation after 4, 8 and 12 weeks of treatment. In some patients cromoglycate was successfully replaced by ketotifen. Efficacy was rated as very good or good in 17 patients and moderate in 3 patients. Tolerance was good in all patients, no serious side-effects were observed. Summing up, it may be stated that ketotifen is a compound which by virtue of its activity profile and route of administration offers a new approach to the prophylactic treatment of bronchial asthma.

Pirbuterol in the treatment of bronchial asthma.

Pirbuterol, a new anti-asthmatic compound, was tested in 21 male outpatients with reversible bronchospastic disease during 12 months in different dosis regimens in order to determine the extent and duration of bronchodilator activity, the optimum multiple dose-schedule, the incidence, type and degree of side effects, and the cardiovascular as well as hematologic, renal and hepatic function after oral administration. All patients were checked by monthly pulmonary function studies, E.C.G. and extensive laboratory tests. Aso slit lamp examinations were performed. Pirbuterol is a well-tolerated bronchodilator which appears to be of clinical importance in the long-term treatment of bronchospastic disease.

Comparative investigation of the respiratory and cardiovascular effect of mepindolol, propranolol and pindolol in asthmatic patients.

In a controlled double-blind crossover trial of 5 mg mepindolol versus 80 mg propranolol, 15 mg pindolol or placebo given as single oral doses in 16 asthmatic patients, respiratory function and cardiovascular parameters were measured simultaneously. The doses chosen of the 3 active drugs were almost equipotent as shown by the similarity in the percentage fall in pulse rates at 2 hr after ingestion, although it was observed that propranolol had a different time course of effect from the 2 other beta blockers. The effect on respiratory function was marked for propranolol, with statistically significant falls in FEV1 and FEV3 at all times; mild for pindolol with lesser falls which were statistically significant only at nearly 3 hr post-ingestion; and intermediate for mepindolol. Mepindolol gave rise to a rapid and statistically significant fall in lying diastolic blood pressure compared to control values; the reductions in diastolic B. P. for propranolol or pindolol were not statistically significant compared to pretreatment control values.

Erythromycin succinate in the treatment of acute exacerbations of chronic bronchitis.

In 20 patients with an acute exacerbation of chronic respiratory tract infection the effectiveness of oral erythromicin succinate 3 X 500 mg daily has been tested. The duration of treatment was 10 days in all cases. The criteria of success, in addition to the clinical findings, were the results of bacteriological investigations and assessment of the appearance of the sputum. In all patients sputum and serum concentrations or erythromicin were determined. All pathogens isolated from the sputum of the patients were erythromicin-sensitive. One instance of development of resistance was observed. The drug was well tolerated.

Comparative study of carbuterol and salbutamol from metered aerosols in bronchial asthma.

In a double-blind crossover trial carbuterol and salbutamol were administered by aerosol for 7 days each to 20 patients with reversible obstructive airways disease. In addition to assessment of subjective response, objective measurements were made of response of the respiratory system (FEV1, FVC, MMEFR) and cardiovascular system (pulse rate, blood pressure, ECG) to each drug. Both carbuterol and salbutamol were found to be effective, well-tolerated bronchodilators when given over a 7 day period; there was no significant difference between the drugs in any of the parameters studied. Carbuterol is a safe and effective alternative to salbutamol.

Objective evaluation of antitussive agents under clinical conditions.

A new method for objective assessment of cough under normal or pathological conditions is described. Thoracic coughing can be discriminated from any other pressure wave because of its relatively high frequency. This method was applied in a double blind crossover trial in 18 patients with respiratory disease.

Antagonism of fenoterol against beta-blocking drugs bunitrolol and practolol in asthmatics.

In 4 X 10 young white male histamine-sensitive asthmatics without bronchitis or emphysema, the antagonism of fenoterol (40 mug) to bunitrolol (2.5 and 5 mg) or practolol (20 and 30 mg) was tested in an open comparative trial. Pulse frequency and several physiological parameters were determined before and after histamine challenge test, after injection of beta-blocking drug and after injection of fenotrolol. All groups were found to be equally sensitive to histamine. Bunitrolol and practolol were found to have no influence on histamine effect. It was also found that bunitrolol in the dosages tested is a much more potent beta-blocking drug in the bronchi compared to practolol in the dosages tested were equivalent. beta-Blockade of practolol (20 or 30 mg) could completely be antagonized by 40 mug fenoterol; this dosage was not sufficient to antagonize 2.5 or 5 mg bunitrolol.