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This open, non-comparative, PMS study of fosinopril (Staril) involved 12,067 hypertensive patients assessed at baseline and after two and six months of treatment; 10,791 patients provided evaluable data with 5.2 months average treatment totalling 4667 patient-years. Adverse events were reported in 24% of patients, the most common being mild-to-moderate cough (6.05%). Events considered possibly related to fosinopril were reported in 15% of patients, the frequency being lower in younger patients, males and those receiving fosinopril monotherapy. Patient well-being improved during the study. At the end of the study, most patients were taking fosinopril 10 mg once daily. Mean reductions in systolic and diastolic blood pressures were -11.0% and -11.7%, respectively; 71.3% of patients were 'responders'. No important differences were observed between subgroups. This study found fosinopril to be effective, well tolerated in a broad range of hypertensive patients, and with no previously unrecognised adverse events reported.

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A randomized, double-blind, double-dummy crossover study on 42 asthmatics was carried out to compare the single dose effects of salbutamol administered from the widely used metered dose inhaler and a breath operated system (Diskhaler). The bronchodilator response (change in forced expiratory volume in the first second) was almost identical for the two systems. The Diskhaler system however, since it is breath operated, obviates the need for hand-breath coordination.

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An open parallel study lasting 24 weeks was performed in 39 asthmatics to evaluate patient compliance and the clinical effects of regular inhalations of beclomethasone dipropionate and salbutamol used simultaneously from a combination inhaler with regular inhalations of salbutamol and beclomethasone dipropionate used sequentially from separate inhalers. Total daily doses in the two groups were 800 micrograms salbutamol and 400 micrograms beclomethasone dipropionate. There were no differences between the two treatment groups with respect to clinic pulmonary function tests (FEV1, FVC), daily PEF measurements, symptom scores, use of symptomatic bronchodilator therapy, requirements for extra medication and patients' and physician's assessment of treatment. At 12 weeks, the physician assessed significantly more patients to have better symptom control on the combination inhaler than on separate inhalers. Patient compliance was high in both treatment groups which may have been due to the close supervision of the clinical study.

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The effect of the simultaneous administration of salbutamol and beclomethasone dipropionate, from a combination inhaler, was compared with the same doses given with an interval of 10 min, from separate inhalers, in a group of 40 asthmatic females. The double-blind parallel-group study was well balanced and lasted 4 weeks. Both groups showed a similar improvement in thrice-weekly lung function values and daily symptoms in week 4 compared to week 1. There were no other differences and no adverse reactions. The combination inhaler is a useful alternative for maintenance treatment in patients who require an inhaled steroid.

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Seventeen asthmatic patients were allocated at random to one of two treatment regimens: prophylactic (10 patients), in which salbutamol inhaler was used regularly in a dose of 200 micrograms 4-times daily; or symptomatic (7 patients), in which a placebo inhaler was used regularly as 2 actuations 4-times daily. In both regimens, an 'escape' salbutamol inhaler was given to be used for symptomatic relief if and when needed. The study lasted 12 months, after a run-in period of 1 month to accustom patients to the trial procedure. At the end of the year, 16 patients transferred to the alternative regimen for a further 3 months. Both groups were well matched except that the group starting with the prophylactic regimen had more severe airways obstruction than the symptomatic group. Patients were assessed by daily scores of their asthmatic symptoms, twice daily PEFR measurements and the amount of anti-asthmatic medication used. Acute reversibility tests were performed every month at the clinic visits. Patients treated prophylactically had less seasonal variation in PEFR and generally lower symptom scores despite a lower mean PEFR. There was no evidence to suggest tolerance was developing either by acute reversibility tests or by an escalating use of symptomatic salbutamol or other anti-asthma medication. The prophylactic use of salbutamol seemed to provide a more stable control of asthma, offering potential benefit to patients.

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A randomized study was carried out in 396 patients requiring inhalation therapy for chronic obstructive lung disease to assess whether a modified, breath-activated device for drug delivery ('Rotahaler') was more effective than the current standard model in opening the hard gelatin cartridge containing the drug in powder form ('Rotacaps'). 'Rotacaps' packaged in two different ways, one specially designed to protect them against environmental changes, were also compared. Patients were asked to open 5 cartridges of each type with each of the two devices. The modified 'Rotahaler' failed to open only 0.7% of both types of 'Rotacaps' whereas the standard model failed to open 13.6% of the foil-packed type and 16.9% of those from a special polypropylene container. There was a statistically significant difference between the two 'Rotahaler' devices and between the two types of 'Rotacaps' in the standard device. More patients preferred the modified 'Rotahaler' (160) than the standard (75). The results did not depend upon age, sex, nationality of the patients or previous 'Rotahaler' experience. It is concluded that the modifications substantially improve the performance of the 'Rotahaler' and should make it easier for patients to use.

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The prophylactic use of beclomethasone dipropionate (BDP) aqueous nasal spray was compared with sodium cromoglycate (SCG) nasal spray in the management of seasonal allergic rhinitis. Eighty-six patients with proven grass pollen sensitivity were given either a BDP or SCG nasal spray to use for six weeks during the hay fever season of 1982. Patients were seen prior to the start of treatment, once during and finally after six weeks therapy. Throughout they kept a daily record of symptoms and medication. Assessments of symptom control showed the BDP to be significantly better than SCG (p less than 0.05). Further analyses, in particular of patients with severe hay fever and days with high pollen counts confirmed the superiority of BDP over SCG in controlling symptoms. It was interesting to note that in study the symptom score correlated best with the pollen counts one day earlier. Additional medication requirements were similar in the two groups. Although the patients' assessments were similar for the two treatments, those of the physician indicated the BDP to be more effective than SCG in preventing or alleviating symptoms. The incidence of side effects was low and similar in both treatment groups. The study indicates that the new BDP aqueous nasal spray is effective and well tolerated by patients with seasonal rhinitis.

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Fifteen patients with chronic asthma completed a double-blind cross-over trial during which they were treated with the same daily doses of salbutamol and beclomethasone dipropionate (BDP) from either a combination inhaler or two separate inhalers. Lung function was measured at the end of each treatment period and each patient kept a diary card throughout. Daily assessments of patients' symptoms and additional medication requirements were similar during both treatment periods. Peak expiratory flow rate (PEFR) recordings taken four times a day showed little diurnal variation during both periods. Mean PEFRs for the groups during a period of 2 weeks were similar for both treatments at all times. Overall daily mean PEFRs showed a trend in favour of the combination inhaler. There was a suggestion of greater variability in airway obstruction during the period when the separate inhalers were used, as assessed by the number of occasions that the PEFR was outside the range (overall daily mean +/- 15%). Lung function measurements at the end of each period showed a trend in favour of the combination inhaler which was clinically significant in terms of the forced expiratory volume in the 1st second and forced vital capacity. The combination inhaler provides an alternative in the management of asthma which is at least as effective as treatment with salbutamol and BDP from two separate inhalers.

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