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Nocturnal Asthma: Effects of Slow-Release Terbutaline on Spirometry and Arterial Blood-Gases

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Nocturnal Asthma: Effects of Slow-Release Terbutaline on Spirometry and Arterial Blood-Gases Eur Aespir J 1988, 1, 302- 305 Nocturnal asthma: effects of slow-release terbutaline on spirometry and arterial blood-gases L. Eriksson •, B. Jonson•, G. Eklundh•*, G. Persson** Nocturnal asthma: effects of slow-release terbutaline on spiromelly and arterial • Departments of Clinical Physiology and blood-gases. L. Eriksson, B. Jonson, G. Eklundh, G. Persson. •• Intemal Medicine, Lund University Hospi­ ABST RACT: The effect of terbutaline, in a slow-release preparation, on tal, S-221 85 LUND, Sweden. spirometry• :lnd arterial blood-gases, was studied in fourteen pa tients with nocturnal asthma. The Jlatients were treated witJ1 either I 5 mg of slow-release Correspondence: L. Eriksson, Department of Clinical Physiology, Lasarettel, S-221 85 terbutaline or placebo ginm as a single dose at 10 pm for eight days in u double­ LUND, Sweden. blind c ros.'iO~·c r trial. The patients were studied in the hospital for one night at the end of cacb treatment period. During active treatment the patients had a Keywords: Arterial blood gases; nocturnal significantly higher FEV 1 and Pao 2 compared with placebo. Tolerance to the asthma; spirometry; tebutaline. high !lingle dose was good and none of the patients discontinued treatment because of s id e~ffccl<;. In patients with nocturnal asthma treatment with a high Received: September 23, 1987; accepted dose of slow-release terbutaline given as a single dose in the evening appears to December 8, 1987. be effective. Eur Respir J. 1988, 1, 302- 305. Early morning wheezing is a common symptom in c) an increase in peak expiratory flow > 15% after asthma [1). The patients can be relatively free of two doses of terbutaline spray. symptoms during the day and their pulmonary The study was designed as a double-blind, placebo­ function tests and chest auscultation may be normal controlled , cross-over study divided into three 8-day or close to normal. However, during the night they periods, a n m-in period followed by two study periods. may have severe airflow limitation leading to dis­ During the run-in period the patients recorded their turbed sleep. Large diurnal variations in bronchomo­ peak expiratory flow (PEF), measured with a mini­ tor tone also seem to be related to an increased risk of Wright peak-flow meter, in the evening and in the sudden death in asthma [2, 3). morning. During this period they were kept on their Treatment of these patients has proven difficult, ordinary medication, which did not include slow-release partly because of lack of drugs with sufficiently long terbutaline. All were on 'plain' oral beta-2-agonists duration to cover the early morning hours when the given three times daily and slow-release theophylline symptoms are often most severe. In recent years, (Theo-DurR, Draco, Sweden) given twice daily. Four of slow-release preparations of both theophylline [4) and the fourteen were on oral steroid.s and ten were on beta-2-receptor stimulants, such as salbutamol [5] and inhaled steroids. All were on inhaled beta-2-agonists terbutaline [6], have been introduced in the treatment and two were also on inhaled anticholinergics. of nocturnal asthma. During the two study periods their o rdinary oral The aims of the present investigation were to study beta-2-stimulants were substituted with either placebo the effect on spirometry and arterial blood-gases of a or active treatment with slow-release terbutaline. single dose of slow-release terbutaline (2 x 7.5 mg Active treatment was given as 1 x 7.5 mg terbutaline Bricanyi-DepotR, Draco, Sweden) given at night, and (Bricanyl DepotR, Draco, Sweden) for three days to study the plasma concentrations of terbutaline which was then increased to 2 x 7.5 mg terbutaline using this dose. for the rest of the period. The tablets were given at 22.00 h. All the patients tolerated the high single dose well. The patients were allowed to keep their broncho­ Patients and Methods dilating aerosols and use them when needed. They Fourteen patients, nine women and five men, with a were told, however, to avoid using them for 5 h before mean age of 50 (range 30- 63) yrs were investigated. each PEF or forced expiratory volume in one second The patients all had a history of nocturnal asthma (FEY 1) measurement. if possible. During the run-in that gave disturbed sleep and early awakening. with week the patients used their ordinary bronchodiJating wheezing which required treatment wirh bronchodi­ aerosols. During the nights in the hospital rimiterol lating aerosol. AparL from the history of nocturnal was given because it has a slightly shorter duration asthma the patients met the following inclusion compared with other beta-2-agonists and because it criteria: a) no cardiopulmonary disease other than would not interfere with the terbutaline analysis. No asthma; b) no airway infection for at least one month; other change in medication was made. NOCTURNAL ASTHMA AND SLOW-RELEASE TERBUTALINE 303 At the end of each of the two study periods the P-Terbutaline, nmoljl patients came to the Department of Clinical Physiol­ 30 ogy at 16.00 h. Static lung volumes were measured with a body plethysmograph and spirometry was performed with a dry spirometer (Vitalograph). Normal values for lung volumes are from BERGLUND 20 et a/. [7] and from GRIMBY et a/. [8]. A radial artery catheter was inserted (Venflon, Viggo) and samples for arterial blood-gases, S­ theophylline and S-terbutaline were drawn. Arterial blood-gases were analysed in an automatic blood-gas 10 analyser (IL 413, Instrumentation Laboratories). The patients then went to one of the medical wards where they were ambulant until 22.00 h when they went to bed. They remained in bed until 07.00 h. Spirometry was performed and S-theophylline was analysed at 22.00, 01.00, 0.40 and 07.00 h. Arterial blood-gases and P-terbutaline were analysed once every hour from Fig. I. Serum-tcrbutaline (mean ±SEM) during active treatment 22.00 to 07.00 h. Heart rate and arterial blood (-x-) and during placebo (-o-). pressure were also measured hourly. P-terbutaUne was analysed with gas chromatography mass-spectro­ metry [9]. Figures in the text are mean ± 1 standard devia­ tion. Student's paired t-test was used for the statistical 80 analysis. 70 Results None of the patients was heavily overweight. They 60 had normal total lung capacity (TLC), 99±8.7% predicted and increased residual volume (RV), 50 133±28.7% predicted. Vital capacity (VC) and 10 8 10 forced expiratory volume in one second (FEV 1) were slightly reduced, 83 ± 12% and 72 ± 19% predicted 40 respectively. Despite being on ordinary medication during the 30 run-in period, eleven patients showed a fall in PEF of more than 20% overnight during three nights or Q400 more. Fig. 2. FEV 1 in % of predicted value (mean ±sF.M) during active Serum theophylline levels were maximal at 16.00 h treatment (-x-) and during placebo (-o-). The numbers above and during both study nights and were 43±20 J.liDOI// below the curves indicate the number of extra doses of bronchodi­ lating spray the patients were given. (7.8±3.6 mgf{) during active treatment and 45± 18 J.lmol/ I (8.2 ± 3.2 mg/{) during placebo. The lowest levels were seen at 07.00 hand were 34±24 J.lmolf/ 27 ± 30% during active treatment and a decrease of (6.2±4.4 mg/{) during treatment and 39±20 J.1molf/ 14± 19% during placebo. The largest decrease during (7 .1 ±3.6 mg/l) during placebo. active treatment in a single patient was 11 %. Eleven Plasma terbutaline measurements during active patients had a higher FEV 1 in the morning than at treatment, (fig. I), showed serum levels of about 10 bedtime. During placebo, five patients had reductions nmol// in the early evening as a result of the dose of more than 20% in FEV 1, the largest decrease being given the previous evening. After drug intake at 44%. On request the patients were given extra doses 22.00 h the plasma terbutaline rose to a peak of about of rimiterol aerosol. The numbers in the figure 26 nmol// at around 06.00 h. Four of the fourteen indicate the number of extra aerosol doses that were patients had low, but detectable, levels of terbutaline given. During the placebo night 28 extra doses were during the placebo night. administered and during the terbutaline night 10 There was no difference in FEV 1 between the {p<O.Ol). placebo and terbutaline periods at 16.00 and 22.00 h, Pao2 was higher throughout the terbutaline night (fig. 2). After tablet intake FEV 1 increased during the compared with placebo (fig. 3). The mean difference night after active drug, and decreased after placebo. was about 0.7 kPa. At any single time during the night The differences between drug and placebo are highly the difference was not significant. However, when significant. The mean overnight change in FEV 1 comparing the mean value calculated for each patient calculated from 22.00 tc 07.00 h was an increase of during the study nights, Pao2 was significantly higher 304 l. ER I KSSON ET AL. Pao2• kPa Low, but detectable, plasma levels of terbutaline were seen in only four patients at the beginning of the placebo night, probably because they had used their 12 terbutaline aerosols. The tolerance to the high once a day dose, 15 mg, was surprisingly good and none of the patients discontinued treatment because of un­ wanted side effects. Objective registration of side 11 effects was not performed.
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