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1 The kinetic disposition of a novel xanthine bronchodilator, enprofylline, was determined in young healthy male volunteers in the presence and absence of amoxycillin or erythromycin. These data were compared to those derived from a similar study of theophylline disposition in the presence and absence of erythromycin. 2 Erythromycin inhibited theophylline disposition only in those subjects in whom the control kinetic study was done after antibiotic ingestion, but the effect was modest. Erythromycin had no effect on enprofylline disposition. 3 Amoxycillin reduced the renal clearance of enprofylline, but the change was not statistically significant.

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Terbutaline sulphate was administered to 40 adult asthmatic patients via an ordinary metered-dose inhaler (MDI) or one connected to a 750-ml spacer in an open, randomized, crossover study. Spirometry was obtained before the start of the study and again after four weeks of treatment with each inhaler. The patients recorded on a diary card the severity of their asthma symptoms and the peak expiratory flow rate (PEFR) in the morning before and after drug administration and in the evening. Preinhalation spirometric values were higher after four weeks with the 750-ml spacer than at the start of the study (P less than or equal to 0.05). Daily morning and evening PEFR values were higher after use of the 750-ml spacer than after use of the ordinary MDI (P less than 0.05). Daily symptom scores were generally low. A significantly better effect (P less than or equal to 0.05) with the 750-ml spacer was achieved only in daytime dyspnea. The investigators conclude that the attachment of a 750-ml spacer to an ordinary metered-dose inhaler can improve the efficacy of terbutaline sulphate in the long-term treatment of asthma.

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Twelve patients with bronchial asthma participated in a blind, randomized, crossover study comparing the effects of 500 micrograms terbutaline in one inhalation, 125 micrograms in four inhalations taken in rapid succession, and 125 micrograms in four inhalations taken with an intervening time interval of 30 min. There were no significant differences between the three modes of inhalation of 500 micrograms terbutaline in any of the spirometric variables, i.e., 1-second forced expiratory volume, forced vital capacity, and maximal airflows when 50 and 75% of the forced vital capacity was exhaled from the total lung capacity. However, there were neither any significant differences between the levels of bronchodilation reached after administration of 500 micrograms and 2 or 3 X 125 micrograms terbutaline with an intervening time interval of 30 min. The time interval between the divided doses was possibly too long to achieve maximum accumulated effect of the four divided doses.

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A bronchodilator aerosol, terbutaline sulphate, was administered to 18 asthmatic children, mean age 8.0 years (range 4.9-13.7 years) in a cross-over trial using either a common actuator or a 750-ml collapsible spacer. With the spacer, peak expiratory flow rate was significantly higher (p less than 0.05) at 5, 20, and 60 min after administration of 0.25 mg terbutaline sulphate. The mean maximum value during this period was 92% of the predicted normal value with the spacer compared to 86% with the common actuator. The difference was significant (p less than 0.01). This study confirms previous findings that a 750-ml spacer is beneficial in bronchodilator aerosol therapy in children with asthma.

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Twelve patients with severe chronic obstructive lung disease, participated in this double-blind, cross-over study. Either terbutaline sulphate aerosol or placebo was delivered via a pressurized aerosol with a 750 ml spacer interposed between the actuator and the mouth, or by an electric compressor nebulizer. Each treatment was given for 1 week. The patients recorded PEF and the use of extra terbutaline aerosol while treating themselves at home. All patients completed the treatment periods on terbutaline. Five patients failed to complete the placebo treatment periods because their condition deteriorated. There was no significant difference in bronchodilatation with 5 mg terbutaline using the nebulizer versus 1.5 mg terbutaline using the spacer. We conclude that in the treatment of severe asthma, a pressurized aerosol with a 750 ml spacer can be used either alone, or as a supplement to, treatment with an electric compressor nebulizer.

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The influence on lung function of small cumulative doses (31 + 31 + 63 + 125 + 250 micrograms) of terbutaline inhalations from a pressurized aerosol with a 750 ml spacer was evaluated in 12 stable asthmatics. The trial was double-blind and cross-over, using the double-dummy method. Lung functions was recorded 5, 30, and 60 min after each inhalation. No significant differences in FEV1, FVC and FMF25-75% were found between the two devices. A very marked response, which was not a placebo effect, was noted after the subjects had inhaled the first 31 micrograms dose. The results suggest that the number of inhalations is more important for the response in lung function than the dose administered. The addition of a 750 ml spacer to the pressurized aerosol is not likely to be beneficial for adults who are able to handle an ordinary aerosol properly.

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The clinical effect of 1.0 mg terbutaline given as a pressurized aerosol with a 750-ml spacer was compared with that of 4.0 mg terbutaline given as a nebulized solution (Pari Inhalier Boy). No differences were found in the parameters measured--forced vital capacity, 1 s forced expiratory volume, forced mid-expiratory flow, and oscillatory resistance. The results indicate that the same clinical response to a given dose of a pressurized aerosol supplied with a 750-ml spacer has the same effect as a fourfold dose via a nebulizer. It is concluded that the more practical 750-ml spacer should be tried when contemplating nebulization therapy.

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The addition of a tube extension or of a pear-shaped spacer to a conventional metered-dose aerosol for delivering a bronchodilator drug, caused a slightly improved bronchodilation in 12 trained, adult patients with stable, reversible airways obstruction of moderate severity. Although statistically significant, the increase in bronchodilation effect does not appear to be clinically relevant in these patients. Continuous measurement of pulmonary resistance using the airflow interruption method did not reveal differences in the time of onset of the bronchodilation.

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A randomized, blind cross-over study was carried out in 12 patients with bronchial asthma to determine whether the bronchodilating effect of a metered dose inhaler was influenced by increasing the metering volume from 25 microliters to 50 microliters, or by increasing the vapour pressure from 374 kPa to 502 kPa. Spirometry, heart rate and tremor were recorded 15 min after terbutaline sulphate 31 micrograms, 63 micrograms, 125 micrograms, 250 micrograms, 2 X 250 micrograms and 5 X 250 micrograms. There was no significant difference in any of the variables recorded i.e. in forced expiratory volume in one second, forced vital capacity or in airflows when 50% and 25% of the FVC remained to be exhaled from the total lung capacity. It is concluded that the bronchodilating effect of a beta 2-agonist from a metered dose inhaler is not substantially affected by changes in metering volume or vapor pressure within the limits studied.

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The long-term effects of a tube extension to the terbutaline sulphate aerosol were studied in 23 patients. The trial was of open, randomised, cross-over design, and compared the ordinary actuator with the tube extension over two 3-week periods. Lung function before and after bronchodilator was measured at the start of the trial, at the treatment cross-over and at the end of the trial. The mean baseline FEV1 value obtained following 3 weeks of treatment with the tube extension was significantly greater (P less than 0.05) than that following treatment with the ordinary actuator. Treatment with the latter, however, produced significantly greater FEV1 values than at the start of the trial (P less than 0.05). At home, the patients recorded symptoms daily, as well as PEF each morning and evening. With the tube extension, the increase in PEF was significantly larger (P less than 0.05) than with the ordinary actuator. There were no differences with regard to symptom score.

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The bronchodilator effects of cumulative doses of terbutaline 0.125 mg, 0.125 mg and 0.250 mg administered as a pressurized aerosol via a pear shaped spacer were compared with those of terbutaline 1.25 mg, 1.25 mg and 2.50 mg administered as a nebulized solution via a PARI-inhaler Boy. FEV1.0 and flow-volume curves in 13 patients were measured. Initial placebo treatment of both groups resulted in a significant increase in FEV1.0, especially when it was given in nebulized form. The increase after active drug was significant after 15 min, with only minor changes during the rest of the trial. The log-dose/increase in FEV1.0 showed that equipotent doses of pressurized and nebulized terbutaline were in the ratio 1 to 4. Administration by nebulization offered no clear advantage over use of a pressurized aerosol with a pearshaped spacer.

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The effect on large and small airways of a pressurized terbutaline aerosol delivered via a 750 ml spacer, or via an ordinary actuator, was investigated in a double-blind study of 15 patients with reversible obstructive airflow disease. There was significant bronchodilatation with both devices as measured by Raw, FEV1.0, PEFR, MEF75, MEF50, and MEF25. Raw showed, a significant difference in favour of the 750 ml spacer. Measurement of Closing Volume (CV) revealed a significant decrease with the spacer, but with the ordinary actuator there was a slight increase in CV; the difference between the devices was significant. The quotient Closing Volume/Vital Capacity (CV/VC%) was significantly decreased with the 750 ml spacer but not with the ordinary actuator. The decrease in volume of isoflow (VisoV) was more pronounced with the spacer but not significantly so. The results suggest that use of a 750 ml spacer may promote more extensive peripheral deposition of the drug in the bronchial tract.

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Using spirometry, the effects on lung function of interposing a tube extension between a bronchodilator aerosol (terbutaline sulphate 0.25 mg) and the mouth and an ordinary aerosol have been compared. Both devices were administered with a delay of 2 s from actuating the aerosol to inhalation, thus simulating inability to coordinate properly. In 12 stable asthmatics it was found that attachment of the tube extension to the aerosol gave significantly better results for one-second forced vital capacity (FEV1.0) and forced vital capacity (FVC). The tube extension seems to be beneficial in patients with hand-lung dyscoordination.

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In a double-blind, cross-over, 2-day study 32 adult asthmatic patients compared the bronchodilating effect of 0.5 mg terbutaline sulphate aerosol, administered via a 10 cm tube extension attached to the actuator of a pressurized aerosol, with that of 0.2 mg salbutamol sulphate, administered by a conventional pressurized aerosol. New instructions for the inhalation technique were given for the terbutaline aerosol, dividing the actuation of the aerosol and the slow inhalation into two steps. The salbutamol aerosol was to be taken according to the instructions enclosed, i.e. coordinating the actuation of the aerosol and the inhalation. The improvement in peak expiratory flow rate (PEFR) values was similar for the two treatments. Subjective assessments by the patients showed no differences between the two regimens. As the effect seems to be equal, an aerosol actuator furnished with a tube extension, with no strict demands of synchronizing the actuation of the aerosol and the inhalation, could be a suitable alternative treatment in patients who find self-administration with conventional asthma aerosols difficult.

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The clinical effects of a bronchodilator, terbutaline sulphate, were compared after administration in the beginning of the inhalation by means of a standard inhaler and administration by actuating 2 seconds before starting the inhalation by means of an inhaler furnished with a 32 X 100 mm tube. No differences could be seen in the parameters measured-forced vital capacity (FVC), 1-second forced expiratory volume (FEV1), forced mid-expiratory flow (FMF), and oscillatory resistance (Ros). The results indicate that when attaching a tube to the standard inhaler co-ordination of inhalation and actuation of the aerosol is not of vital importance.

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