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An open, multicenter non-comparative study was carried out in 8 centres in Italy to evaluate the efficacy, safety and tolerability of cefixime (Suprax - Lederle), a third generation oral cephalosporin administered once daily to patients affected by exacerbation of chronic bronchitis. All patients, 124 males and 21 females, aged between 50 and 85, were treated with Suprax at the dose of 400 mg/day for a mean period of 7.4 days. Clinical and laboratory examinations were performed at: T0 (beginning of treatment), T1 (3-4 days after the beginning of treatment), T2 (end of treatment). The following signs/symptoms were recorded in order to evaluate the therapeutic efficacy: sputum quality and quantity, cough, dyspnoea, fever, bronchospasm, chest clinical findings. All these signs and symptoms significantly improved (p between < 0.001 and < 0.05; mean improvement for sign, weighted for time of improvement). Bio-humoral parameters were also recorded in order to evaluate potential therapeutic influences. A significant decrease was observed (p < 0.01 Student t test for paired data) in the white blood cell count and the leukocyte formula. The datum regarding the white blood cell count and leukocyte formula is to be considered a primary effect of the treatment, proving its success. A microbiological search for the pathogen responsible for the infectious process was also performed: in 70/145 subjects the responsible pathogen was identified. The micro-organism was eradicate in 66/70 at T2 (94.3%), the difference T0 = T2 is significant. The X-Ray evidence suggesting a chronic bronchitis, was also evaluated in 81 patients. At T2, in 75/81 subjects the X-Ray evidence turned out to be negative, while in 6/81 it remained positive. This difference was statistically significant (p < 0.01 sign test). An overall clinical evaluation showed a therapeutic success in 133/145 treated patients (91.7%). No side effects were observed.

We conducted a multicentre, double-blind, parallel group study to compare the clinical efficacy of a new antitussive drug, moguisteine (100 mg t.i.d.), to that of a reference standard, codeine (15 and 30 mg, t.i.d.). Both drugs were given orally for a period of two days. A group of 119 patients (mean age 54 yrs; 61 females and 58 males) with chronic, dry or slightly productive cough, associated with various respiratory disorders (including chronic obstructive pulmonary disease, respiratory malignancies and pulmonary fibrosis) were enrolled at six participating centres. The percentage reduction in the number of morning coughs over a period of 6 h after the first administered dose compared to baseline assessment, was 21% with moguisteine (n = 39), 28% with codeine 15 mg (n = 38), and 29% with codeine 30 mg (n = 36). Differences between treatments were not significant. The percentage reduction in the number of nocturnal coughs per hour, after the last evening dose compared to baseline assessment, was 33, 46 and 52%, respectively. Subjective assessments (patients' visual analogue scale scores of cough frequency, cough intensity and sleep disturbance, and investigators' ranking of cough severity) indicated that there was a similar improvement in cough symptoms in all treatment groups. Adverse events were observed in two patients on moguisteine, three on codeine 15 mg, and five on codeine 30 mg. No event was serious, but discontinuation of treatment was required in two patients on codeine 30 mg. The results of our study suggest that moguisteine 100 mg t.i.d. is safe, and seems to have an antitussive activity similar to that of codeine 15-30 mg t.i.d.

This completely randomised, double-blind, placebo-controlled, multicentre trial was carried out to evaluate the antitussive activity and safety of a 200 mg t.i.d. regimen of moguisteine (20 mg/ml ready-to-use suspension) during four days in patients with cough associated to chronic respiratory disorders. A total of 87 patients were enrolled, 42 on moguisteine and 45 on placebo. All had persistent dry or slightly productive coughs associated with chronic respiratory disorders. Seventy three were submitted to per protocol efficacy analyses, and eighty-three to intention-to-treat efficacy analyses. All the patients who were administered the study drug were analysed for safety. The underlying disorders reported as being associated with the target symptom were chronic obstructive pulmonary disease, cough of unknown aetiology, respiratory tract malignant neoplasms and pulmonary fibrosis. The treatment groups appeared to have been homogeneous on admission. The number of coughs in the interval 8-10 a.m. on day four vs day one was reduced by 42% on moguisteine against 14% on placebo; the difference between treatments was statistically significant (p = 0.028). The mean percent reduction of ladder scale scores of cough frequency vs baseline was greater on moguisteine than on placebo both in the day-time (especially on days one and two), and at night. The antitussive activity of moguisteine did not show remarkable variations either by diagnosis or by type of cough (dry/slightly productive). No serious adverse events were reported. No changes/trends were identified in laboratory tests that might indicate functional or toxic effects of moguisteine on specific organs.

Forty-three patients treated with amiodarone hydrochloride with an average daily dose of 204.7 +/- 79.4 mg/day for a mean period of 37.1 +/- 25.3 months, were studied by clinical examination, chest roentgenograms, pulmonary function tests and blood gas analyses. The habits of cigarette smoking were also recorded and expressed as cigarette pack/years. Pulmonary function tests did not show any differences from control subjects and no correlation was found between exposure to drug and lung function. However, one patient developed abnormalities in the chest X-ray (interstitial type) and a reduction of carbon monoxide diffusion capacity as a possible manifestation of amiodarone lung toxicity. Nine patients (22%) had a 20% decrease from normal in carbon monoxide diffusion capacity and three (7%) had a 15% decrease in total lung capacity. More treated patients had interstitial abnormalities in the chest X-ray (14%) than controls (5.5%). Although pulmonary function test abnormalities could be detected in patients taking amiodarone, they were not usually severe enough to interfere with gas exchange. Our results confirm the rarity of amiodarone lung toxicity when a low dosage is used, and suggest the advisability of periodical monitoring, including clinical examination, chest X-ray and pulmonary function tests in order to detect the earliest signs of amiodarone lung toxicity.

The Authors consider the global evaluation of clinical and functional data in patients with the following radiological features: 1) X-ray thoracic aspects characterized by marked broncho-vascular bundles and diffusion of reticular nodulation as in diffuse interstitial pulmonary fibrosis; 2) lack of ECG and clinical signs of heart failure. Since a reversibility of radiological alterations was considered a favourable reply to bleeding and diuretic acute and long term therapy the Authors suggest that these patterns should be related to a different distribution of hydric and haematic masses with a decreasing of interstitial pulmonary oedema which contributes to a full interlobar septa like "D" lines shadows, according to Kreel, (1975). The Authors, moreover, relate these clinical, functional and radiological aspects to the patterns of "wet lung" distinguished from the cardiac lung caused by congestive heart failure and from interstitial lung fibrosis.