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Bronchodilator Response and Lung Mucociliary Clearance in Patients with Mild Stable Asthma J.R.M

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Bronchodilator Response and Lung Mucociliary Clearance in Patients with Mild Stable Asthma J.R.M Br. J. clin. Pharmac. (1983), 15, 695-700 EFFECTS OF TERBUTALINE SULPHATE AEROSOL ON BRONCHODILATOR RESPONSE AND LUNG MUCOCILIARY CLEARANCE IN PATIENTS WITH MILD STABLE ASTHMA J.R.M. BATEMAN*, D. PAVIA, N.F. SHEAHAN, S.P. NEWMAN & S.W. CLARKE Department ofThoracic Medicine, Royal Free Hospital, Pond Street, London NW3 2QG 1 Ventilatory function and whole lung mucociliary clearance have been assessed in 10 patients with mild stable asthma following inhalation of 1 mg of the ,8-adrenergic receptor agonist terbutaline sulphate (Bricanyl, Astra Pharmaceuticals) from a metered dose inhaler (MDI). 2 Compared to placebo inhalation, terbutaline produced marked bronchodilatation (mean percent- age increase in FEV1 14%, P < 0.01). 3 Mucociliary clearance (measured by the in vivo radioaerosol technique) was assessed on three occasions-control, followed by placebo or terbutaline studies in a double-blind, cross-over manner. 4 Particles were removed from the lung at a similar rate in all three studies. The mean (± s.e. mean) percentage of aerosol retained in the lungs after 6 h was 58 + 5%, 57 + 5% and 57 + 4% for control, placebo and drug studies respectively. 5 It is concluded that terbutaline sulphate, given as a 1 mg acute dose, does not enhance mucociliary clearance in mild stable asthmatics, although it produces marked bronchodilatation. Introduction Methods ,8-adrenergic receptor agonists are intended primarily Study design to relieve bronchospasm in patients with reversible airways obstruction. These substances may have Ten patients (six male, four female) clinically diag- valuable additional effects however, including in- nosed as having mild stable asthma were investigated. hibition of mediator release (Sorenby, 1975) and the All patients had demonstrated previously an increase enhancement of mucus transport. Terbutaline of ' 15% in the forced expiratory volume in 1 second sulphate is a typical /3-adrenoceptor agonist in that it (FEV1) following bronchodilator inhalation. All has a powerful bronchodilator action when given by a were taking bronchodilator aerosols on a regular variety of routes (Freedman, 1971; Koch, 1972; basis, but none was taking oral or inhaled corti- Michaelson et al., 1978). It selectively stimulates AR- costeroids. The mean age of the patients was 44 (s.e. adrenoceptors in the bronchial tree, whilst having mean 5) years; the mean weight 79 (s.e. mean 4) kg little or no effect upon cardiac A-adrenoceptors. and the mean height 1.69 (s.e. mean 0.03) metres. Terbutaline enhances tracheal mucus velocity when Mean (± s.e. mean) tobacco consumption was 19 + 6 given subcutaneously to patients with airways ob- pack-years. Two patients were non-smokers, five ex- struction (Mossberg et al., 1976a; 1976b) and to smokers and three current smokers. healthy subjects (Camner et al., 1976). However, the In all, each patient performed five studies on five effect of terbutaline on mucus transport when separate days at least 48 h but not more than 1 week administered via a pressurized metered dose inhaler apart. In the first two studies, bronchodilator response (MDI) is largely unknown. We have investigated the to either 1 mg terbutaline sulphate aerosol (Bricanyl, acute effects upon both bronchodilator response and Astra Pharmaceuticals) or placebo aerosol was lung mucociliary clearance of a 1 mg dose ofterbutaline assessed in a double-blind cross-over manner. Five of sulphate, given from an MDI to patients with mild the patients were given terbutaline and five patients stable asthma. given placebo during the first of these two studies. Mucociliary clearance was measured during the third, *Present address: Derby Chest Clinic, 93 Green Lane, fourth and fifth studies. In the third study, a control Derby DE1 1RX mucociliary clearance measurement was performed. 0306-5251 83 '0600-6950 $02.00 © 1983 Blackwell Scientific Publications 696 J.R.M. BATEMAN, D. PAVIA, N.F. SHEAHAN, S.P. NEWMAN & S.W. CLARKE In the fourth and fifth studies mucociliary clearance administration and radioaerosol inhalation was was assessed following administration of either 1 mg approximately 1 min. terbutaline sulphate aerosol (Bricanyl, Astra Phar- Immediately following radioaerosol inhalation, the maceuticals) or placebo aerosol in a double-blind initial topographical distribution of deposited particles cross-over manner. Patients refrained from taking in the right lung was measured using a rectilinear their prescribed bronchodilators for 12 h prior to gamma scanner (Dawson et al., 1971). The scanner commencement of all studies, for the duration of the recorded radioactivity in a series of vertical traverses bronchodilator response studies and during the initial of the right lung, each of width 2.5 cm. An aerosol 6 h recording period in mucociliary clearance studies. penetration index (API) was calculated as the All patients gave informed consent in writing, and quantity of radioactivity detected over the peripheral the investigations were approved both by the Ethical two-fifths of the lung compared to that recorded over Practices Committee of the Hospital and the the inner two-fifths (Thomson et al., 1975). Radioisotope Advisory Panel of the Department of Clearance of particles from the lungs was recorded Health and Social Security. using two diametrically opposed scintillation probes, one located anteriorly over the midsternum, and the Bronchodilator response studies other location posteriorly. Counts emanating from the chest were recorded immediately after radio- Patients inhaled either four puffs (1 mg) terbutaline aerosol inhalation and then at hourly intervals for 6 h. sulphate aerosol or four puffs of placebo aerosol These counts were corrected for background and which consisted of chlorofluorocarbons 11, 12 and radioactive decay. Patients returned after 24 h for a 114 with sorbitan trioleate surfactant (14mg ml-') but final measurement of chest radioactivity. The no active drug particles. Bronchodilator response was quantity of aerosol retained in the lungs after 24 h, assessed from simple spirometric tests. FEV, and corrected for background and radioactive decay, was forced vital capacity (FVC) were measured using a taken to be alveolar deposition, on the assumption dry bellows spirometer (Vitalograph) and peak that those particles deposited on the conducting expiratory flow rate (PEFR) was measured using a airways had been removed by mucociliary clearance Wright peak flow meter. These tests were performed and productive coughing by that time. The number of prior to drug or placebo inhalation, and then 15, 30, coughs and expectoration of sputum was recorded 60 and 120 min later. Changes in maximal forced during the 6 h following radioaerosol inhalation. expiratory flow rate at 50% vital capacity (Vmax 50) were measured at 15 and 120 min post inhalation from Statistical analysis maximal expiratory flow-volume curves using an The data were not assumed to be normally distributed, Ohio 840 spirometer coupled to a Byrans X-Y and statistical significance was assessed by non- plotter. The highest of three technically acceptable parametric methods. The tests used were the readings was recorded at each time for each lung Wilcoxon rank sum test for paired data and the function test. Friedman analysis ofvariance by ranks (Siegel, 1956). Mucociliary clearance studies Results Whole lung mucociliary clearance was assessed using the in vivo radioaerosol technique which has already Bronchodilator response studies been reported more fully elsewhere (Thomson & Short, 1969). Patients inhaled in a controlled manner Inhalation of 1 mg terbutaline sulphate aerosol particles of polystyrene, firmly labelled with the resulted in marked bronchodilatation in the 10 gamma-emitting isotope 99rc. Inhalation, limited to asthmatic subjects throughout the 2 h recording a volume of450 ml, commenced at functional residual period. After 30 min, the mean (+ s.e. mean percent- capacity (FRC) and was followed by 3 s breath-holding age change in FEV, was 14 + 3% for terbutaline, and to allow particles to settle onto the airways at their -1 + 2% for placebo (P < 0.01). Similar changes furthest point of penetration. Inhaled flow rate was were noted for PEFR (drug 17 + 4%, placebo 0 + monitored by a pneumotachygraph. 2%, P < 0.01), and the change in FVC was also Immediately prior to radioaerosol inhalation, significantly (P < 0.01) enhanced after terbutaline FEV1, FVC and maximum mid-expiratory flow rate inhalation. Changes in Vm., 50 after terbutaline (MMEF) were assessed using a Vitalograph inhalation were also greater than those after placebo spirometer, and PEFR using a Wright peak flow inhalation, but these differences did not attain meter. In the drug and placebo runs, four puffs of statistical significance. Baseline FEV, values were either terbutaline sulphate (Bricanyl, Astra Phar- similar on the 2 study days, being 2.70 1 (s.e. mean maceuticals) or placebo were then administered from 0.34 1) on the terbutaline day and 2.86 1 (s.e. mean an MDI. The time interval between drug or placebo 0.35 1) on the placebo day. EFFECTS OF TERBUTALINE SULPHATE AEROSOL 697 Mucociliary clearance studies The clearance of radioactive particles from the lungs is shown in Figure 1. The quantity of radioactive particles remaining in the lungs is plotted against time as a percentage of the amount initially present. There 60, were no significant differences between control, 50- placebo and drug studies in the amount of aerosol '40- retained in the lungs at any time up to 24 h after radioaerosol inhalation. After 6 h, the mean (± s.e. mean whole lung retention of radioaerosol was 58 + 5%, 57 ± 5% and 57 + 4% for control, placebo and 10. drug studies respectively. Mean (+ s.e. mean) 1 2 3 4 5 6 24 alveolar deposition, as indicated by the 24 h whole Time (h) lung retention, was 39 + 4%, 40 + 5% and 44 + 6% for the three studies. This indicated that mucociliary Figure 2 Acute effect of inhaled terbutaline sulphate (1 mg) on tracheobronchial clearance in 10 patients with clearance was unaltered by terbutaline compared mild stable asthma. Group mean retention of deposited either to placebo or to the control study.
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