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.

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.

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.

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.