Summary
The recommendations, according to international guidelines, for moderate asthma poorly controlled by inhaled corticosteroid therapy (800 to 1000 μg/day) — Step Three asthma — is a combination treatment strategy consisting of a longacting bronchodilator plus an inhaled corticosteroid. This comparative multicentre, randomised, open, parallel-group study was designed to compare salmeterol (50μg twice daily) + beclomethasone dipropionate (BDP) [500μg twice daily] (both administered via metered dose inhaler) with slow-release (SR) terbutaline (5mg twice daily) + budesonide (BUD) [400μg twice daily] (administered via tablet and dry powder inhaler, respectively) for the treatment of Step Three asthma. The effects of the two combination regimens were assessed using lung function measurements, asthma symptoms, frequency of use of rescue β2-agonist, overall efficacy, quality of life and tolerability. After a 2-week run-in period, 98 patients were randomised to receive salmeterol/BDP and 96 to receive SR-terbutaline/BUD for 8 weeks. Both treatment arms significantly improved all of the above parameters. However, the improvements observed in the salmeterol/BDP group were significantly better than those in the SR-terbutaline/BUD group for the following parameters: increase in spirometric and homemonitored peak expiratory flow (PEF), reduction in diurnal variation of PEF, reduction in use of daytime salbutamol as rescue medication, patients’ and investigators’ assessment of efficacy, and improvement in quality-of-life score using the Qualité de Vie Subjective de l’Asthmatique questionnaire. Both drug combinations were well tolerated, with slightly fewer patients experiencing treatmentrelated adverse events in the salmeterol/BDP group (9 vs 14%). In conclusion, whilst both combination regimens achieved the goals set out in the management of asthma guidelines for Step Three asthma, greater control of asthma was observed using the salmeterol/BDP combination in this asthmatic patient population.
Similar content being viewed by others
References
Cochrane GM. Bronchial asthma and the role of β2-agonists. Lung 1990; 168 (Suppl.): 66–70
Barnes PJ. A new approach to the treatment of asthma. N Engl JMed 1989; 321: 1517–27
National Heart, Lung and Blood Institute, National Institutes of Health. International consensus report on diagnosis and treatment of asthma. Eur Respir J 1992; 5: 601–41
British Thoracic Society. Guidelines on the management of asthma. Thorax 1993; 48 Suppl. 2: S1–24
Hargreave FE, Dolovich J, Newhouse NT. The assessment and treatment of asthma: a conference report. J Allergy Clin Immunol 1990; 85: 1098–111
Quanjer PH. Standardized lung function testing. Clin Respir Physiol 1983; 19 Suppl. 5: 1–95
Hyland ME, Finnis S, Irvine SH. A scale for assessing quality of life in adult asthma sufferers. J Psychosom Res 1991; 35: 99–110
MacHorney CA, Ware JE, Raczek AE. The MOS 36-item shortform health survey (SF36) — II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care 1993; 31: 247–63
MacHorney CA, Ware JE, Lu JF, et al. The MOS 36-item shortform health survey (SF36) — III. Test of data quality, scaling assumptions, and reliability across diverse patients groups. Med Care 1994; 32: 40–66
Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF36) — I. Conceptual framework and item selection. Med Care 1992; 36: 473–83
Wilcoxon F. Individual comparisons by ranking methods. Biometrics 1945; 1: 80–3
Fisher RA, Yates F, editors. Statistical tables for biological, agricultural and medical research. 5th ed. Edinburgh: Oliver & Boyd, 1957
Löfdahl CG, Chung KF. Long-acting β2-adrenoreceptor agonists: a new perspective in the treatment of asthma. Eur Respir J 1991; 4: 218–26
Boyd G. Salmeterol xinofoate in asthmatic patients under consideration for maintenance oral corticosteroid therapy. Eur Respir J 1995; 8: 1494–8
Faurschou P, Jacques L, European Respiratory Group. The effect of addition of salmeterol to the treatment of moderate to severe asthmatic uncontrolled on high dose inhaled steroids [abstract]. Am J Respir Crit Care Med 1994; 149: 209
Greening AP, Ind PW, Northfield M, et al. Added salmeterol versus higher-dose corticosteroid in asthma patients with symptoms on existing inhaled corticosteroid. Lancet 1994; 344: 219–24
Woolcock A, Lundback B, Ringdal N, et al. Comparison of addition of salmeterol to inhaled steroids with doubling the dose of inhaled steroids. Am J Respir Crit Care Med 1996; 153: 1481–8
Dahl R, Pedersen B, Hägglöf B. Nocturnal asthma: effect of treatment with oral sustained-release terbutaline, inhaled budesonide, and the two in combination. J Allergy Clin Immunol 1989; 83: 811–5
Fugleholm AM, Ibsen TB, Laxmyr L, et al. Therapeutic equivalence between bambuterol, 10 mg once daily, and terbutaline controlled release, 5 mg twice daily, in mild to moderate asthma. Eur Respir J 1993; 6: 1474–8
Pauwels R, Elinck W, Lamont H, et al. A comparison of the clinical and bronchodilating effects of plain and slow-release tablets of terbutaline at steady state. Br J Clin Pharmacol 1986; 21: 217–22
Selroos O, Backman R, Forsaaen K-O, et al. Clinical efficacy of budenoside Turbuhaler® compared with that of beclomethasone dipropionate pMDI with volumatic space: a 2-year randomized study in 102 asthma patients. Allergy 1994; 49: 833–6
Brambilla C, Chastang C, Georges D, et al. Salmeterol versus SR terbutaline in nocturnal asthma: a multicentre, randomised, double-blind, double-dummy, sequential clinical trial. Allergy 1994; 49: 421–6
Faurschou P, Engel A-M, Haanaes OC. Salmeterol in two different doses in the treatment of nocturnal bronchial asthma poorly controlled by other therapies. Allergy 1994; 49: 827–32
Pearlman DS, Chervinsky P, La Force C, et al. Acomparison of salmeterol with albuterol in the treatment of mild-to-moderate asthma. N Engl J Med 1992; 327: 1420–5
Justicia JL, Segurado E, Muatnoz MA, et al. Salmeterol versus bambuterol in noctural asthma [abstract]. Allergy 1995; 50 Suppl. 26: 315–6 (P0696)
Palmer JBD, Hyland ME. Salmeterol in clinical practice: comparator and safety studies, quality of life studies. Eur Respir Rev 1991; 1: 301–3
Castle W, Fuller R, Hall J. Serevent nationwide surveillance study: comparison of salmeterol with salbutamol in asthmatic patients who require regular bronchodilator treatment. BMJ 1993; 306: 1034–7
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Didier, A., Campos Oriola, R. A Two-Month Comparison of Salmeterol/Beclomethasone and Slow-Release Terbutaline/Budesonice in Moderate Asthma Management. Clin. Drug Investig. 14, 1–11 (1997). https://doi.org/10.2165/00044011-199714010-00001
Published:
Issue Date:
DOI: https://doi.org/10.2165/00044011-199714010-00001