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Sustained-Release Terbutaline vs Sustained-Release Theophylline in Young Patients With Asthma

Sustained-Release Terbutaline vs Sustained-Release Theophylline in Young Patients With Asthma Abstract • Twenty patients with asthma (mean age, 10.9 ±2 years) entered a six-week, randomized, double-blind, crossover comparison of sustained-release (S-R) terbutaline sulfate (Bricanyl Durules) vs S-R theophylline (Theo-Dur). In each two-week study period each patient received S-R theophylline twice daily in doses previously adjusted to give serum theophylline concentrations in the range of 10 to 20 mg/L (56 to 111 μmol/L); or S-R terbutaline sulfate, 5 mg twice daily; or S-R terbutaline sulfate, 7.5 mg twice daily. All treatment regimens produced significant improvement in one or more pulmonary function test values compared with prestudy values. The incidence of acute asthma episodes were similar during each treatment regimen. No clinically significant differences occurred between the regimens for daily symptom scores, peak expiratory flow rates, or use of a terbutaline metereddose inhaler. At the end of the theophylline treatment period, the mean (±SD) theophylline level 12 to 14 hours after the last dose was 10.1± 3.3 mg/L (56±18 μmol/L); at the end of the terbutaline treatment periods, the mean trough terbutaline levels were 2.22 μg/L (9.9±4.4 nmol/L) (S-R terbutaline sulfate, 5 mg twice daily) and 3.07 μg/L (13.7± 5.4 nmol/L) (S-R terbutaline sulfate, 7.5 mg twice daily). Adverse effects, including tremor, occurred with similar frequency during all three drug regimens. Sustained-release formulations of theophylline and terbutaline, in the dosages studied, provided comparable control of asthma symptoms. (AJDC 1986;140:650-654) References 1. Leegaard J, Fjulsrud S: Terbutaline in children with asthma . Arch Dis Child 1973;48: 229-232.Crossref 2. Blumberg MZ, Tinkelman DG, Ginchansky EJ, et al: Terbutaline and ephedrine in asthmatic children . Pediatrics 1977;60:14-19. 3. Michaelson ED, Silva GT, Forrest TR, et al: Effects of oral terbutaline in children with bronchial asthma . J Allergy Clin Immunol 1978;61: 365-369.Crossref 4. Ardal B, Beaudry P, Eisen AH: Terbutaline in asthmatic children: A dose-response study . J Pediatr 1978;93:305-308.Crossref 5. Simons FER, Pizey DM, Archer JW, et al: Terbutaline elixir in preschool children with chronic asthma . Ann Allergy 1979;43:275-278. 6. Manaligod LM, Gavani UD, Hyde JS, et al: Safety and effectiveness of terbutaline in children with chronic asthma . Chest 1979;76:532-535.Crossref 7. Haddad ZH, Stumbaugh S, Davis WR: A comparison of the bronchodilator and other responses of children to oral treatment with terbutaline tablet and solution: A bioequivalence study . Ann Allergy 1980;44:86-90. 8. Lonnerholm G, Foucard T, Lindstrom B: Dose, plasma concentration, and effect of oral terbutaline in long-term treatment of childhood asthma . J Allergy Clin Immunol 1984;73: 508-515.Crossref 9. Taudorf E, Bundgaard A, Fagerstrom PO, et al: Terbutaline depot tablets in asthma . Allergy 1981;36:495-500.Crossref 10. Eriksson NE, Haglind K, Ljungholm K: A comparison of sustained-release terbutaline and ordinary terbutaline in bronchial asthma . Br J Dis Chest 1982;76:202-204.Crossref 11. Wettrel G, in discussion, Nyberg L, Kennedy BM: Pharmacokinetics of terbutaline given in slow-release tablets . Eur J Respir Dis 1984; 65( (suppl 134) ):137-139. 12. Foged N, Host A, Ljungholm K: Terbutaline depot tablets in childhood asthma . Allergy 1985;40:497-500.Crossref 13. Bell T, Bigley J: Sustained-release theophylline therapy for chronic childhood asthma . Pediatrics 1978;62:352-358. 14. Kelly HW, Murphy S: Efficacy of a 12-hour sustained-release preparation in maintaining therapeutic serum theophylline levels in asthmatic children . Pediatrics 1980;66:97-102. 15. Scott PH, Tabachnik E, MacLeod S, et al: Sustained-release theophylline for childhood asthma: Evidence for circadian variation of theophylline pharmacokinetics . J Pediatr 1981;99: 476-479.Crossref 16. Simons FER, Luciuk GH, Simons KJ: Sustained-release theophylline for treatment of asthma in preschool children . AJDC 1982;136: 790-793. 17. Dickman ML, Schmidt CD, Gardner RM: Spirometric standards for normal children and adolescents (ages 5 years through 18 years) . Am Rev Respir Dis 1971;104:680-687. 18. Cherniack RM: Ventilatory function in normal children . Can Med Assoc J 1962;87:80-81. 19. Jacobsson S-E, Jonsson S, Lindberg C, et al: Determination of terbutaline in plasma by gas chromatography chemical ionization mass spectrometry . Biomed Mass Spectrometry 1980;7:265-268.Crossref 20. Simons KJ, Frith EM, Simons FER: Dissolution and bioavailability studies of whole and halved sustained-release theophylline tablets . J Pharm Sci 1982;71:505-511.Crossref 21. Feinstein AR: Clinical Biostatistics . St Louis, CV Mosby Co, 1977. 22. Bengtsson B, Fagerstrom PO: Extrapulmonary effects of terbutaline during prolonged administration . Clin Pharmacol Ther 1982;31: 726-732.Crossref 23. Hultquist C, Lindberg C, Nyberg L, et al: Kinetics of terbutaline in asthmatic children . Eur J Respir Dis 1984;65( (suppl 134) ):195-203. 24. Nyberg L, Kennedy BM: Pharmacokinetics of terbutaline given in slow-release tablets . Eur J Respir Dis 1984;65( (suppl 134) ):119-137. 25. Billing B, Dahlqvist R, Garle M, et al: Separate and combined use of terbutaline and theophylline in asthmatics . Eur J Respir Dis 1982;63:399-409. 26. Wolfe JD, Tashkin DP, Calvarese B, et al: Bronchodilator effects of terbutaline and aminophylline alone and in combination in asthmatic patients . N Engl J Med 1978;298:363-367.Crossref http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png American Journal of Diseases of Children American Medical Association

Sustained-Release Terbutaline vs Sustained-Release Theophylline in Young Patients With Asthma

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Publisher
American Medical Association
Copyright
Copyright © 1986 American Medical Association. All Rights Reserved.
ISSN
0002-922X
DOI
10.1001/archpedi.1986.02140210048023
Publisher site
See Article on Publisher Site

Abstract

Abstract • Twenty patients with asthma (mean age, 10.9 ±2 years) entered a six-week, randomized, double-blind, crossover comparison of sustained-release (S-R) terbutaline sulfate (Bricanyl Durules) vs S-R theophylline (Theo-Dur). In each two-week study period each patient received S-R theophylline twice daily in doses previously adjusted to give serum theophylline concentrations in the range of 10 to 20 mg/L (56 to 111 μmol/L); or S-R terbutaline sulfate, 5 mg twice daily; or S-R terbutaline sulfate, 7.5 mg twice daily. All treatment regimens produced significant improvement in one or more pulmonary function test values compared with prestudy values. The incidence of acute asthma episodes were similar during each treatment regimen. No clinically significant differences occurred between the regimens for daily symptom scores, peak expiratory flow rates, or use of a terbutaline metereddose inhaler. At the end of the theophylline treatment period, the mean (±SD) theophylline level 12 to 14 hours after the last dose was 10.1± 3.3 mg/L (56±18 μmol/L); at the end of the terbutaline treatment periods, the mean trough terbutaline levels were 2.22 μg/L (9.9±4.4 nmol/L) (S-R terbutaline sulfate, 5 mg twice daily) and 3.07 μg/L (13.7± 5.4 nmol/L) (S-R terbutaline sulfate, 7.5 mg twice daily). Adverse effects, including tremor, occurred with similar frequency during all three drug regimens. Sustained-release formulations of theophylline and terbutaline, in the dosages studied, provided comparable control of asthma symptoms. (AJDC 1986;140:650-654) References 1. Leegaard J, Fjulsrud S: Terbutaline in children with asthma . Arch Dis Child 1973;48: 229-232.Crossref 2. Blumberg MZ, Tinkelman DG, Ginchansky EJ, et al: Terbutaline and ephedrine in asthmatic children . Pediatrics 1977;60:14-19. 3. Michaelson ED, Silva GT, Forrest TR, et al: Effects of oral terbutaline in children with bronchial asthma . J Allergy Clin Immunol 1978;61: 365-369.Crossref 4. Ardal B, Beaudry P, Eisen AH: Terbutaline in asthmatic children: A dose-response study . J Pediatr 1978;93:305-308.Crossref 5. Simons FER, Pizey DM, Archer JW, et al: Terbutaline elixir in preschool children with chronic asthma . Ann Allergy 1979;43:275-278. 6. Manaligod LM, Gavani UD, Hyde JS, et al: Safety and effectiveness of terbutaline in children with chronic asthma . Chest 1979;76:532-535.Crossref 7. Haddad ZH, Stumbaugh S, Davis WR: A comparison of the bronchodilator and other responses of children to oral treatment with terbutaline tablet and solution: A bioequivalence study . Ann Allergy 1980;44:86-90. 8. Lonnerholm G, Foucard T, Lindstrom B: Dose, plasma concentration, and effect of oral terbutaline in long-term treatment of childhood asthma . J Allergy Clin Immunol 1984;73: 508-515.Crossref 9. Taudorf E, Bundgaard A, Fagerstrom PO, et al: Terbutaline depot tablets in asthma . Allergy 1981;36:495-500.Crossref 10. Eriksson NE, Haglind K, Ljungholm K: A comparison of sustained-release terbutaline and ordinary terbutaline in bronchial asthma . Br J Dis Chest 1982;76:202-204.Crossref 11. Wettrel G, in discussion, Nyberg L, Kennedy BM: Pharmacokinetics of terbutaline given in slow-release tablets . Eur J Respir Dis 1984; 65( (suppl 134) ):137-139. 12. Foged N, Host A, Ljungholm K: Terbutaline depot tablets in childhood asthma . Allergy 1985;40:497-500.Crossref 13. Bell T, Bigley J: Sustained-release theophylline therapy for chronic childhood asthma . Pediatrics 1978;62:352-358. 14. Kelly HW, Murphy S: Efficacy of a 12-hour sustained-release preparation in maintaining therapeutic serum theophylline levels in asthmatic children . Pediatrics 1980;66:97-102. 15. Scott PH, Tabachnik E, MacLeod S, et al: Sustained-release theophylline for childhood asthma: Evidence for circadian variation of theophylline pharmacokinetics . J Pediatr 1981;99: 476-479.Crossref 16. Simons FER, Luciuk GH, Simons KJ: Sustained-release theophylline for treatment of asthma in preschool children . AJDC 1982;136: 790-793. 17. Dickman ML, Schmidt CD, Gardner RM: Spirometric standards for normal children and adolescents (ages 5 years through 18 years) . Am Rev Respir Dis 1971;104:680-687. 18. Cherniack RM: Ventilatory function in normal children . Can Med Assoc J 1962;87:80-81. 19. Jacobsson S-E, Jonsson S, Lindberg C, et al: Determination of terbutaline in plasma by gas chromatography chemical ionization mass spectrometry . Biomed Mass Spectrometry 1980;7:265-268.Crossref 20. Simons KJ, Frith EM, Simons FER: Dissolution and bioavailability studies of whole and halved sustained-release theophylline tablets . J Pharm Sci 1982;71:505-511.Crossref 21. Feinstein AR: Clinical Biostatistics . St Louis, CV Mosby Co, 1977. 22. Bengtsson B, Fagerstrom PO: Extrapulmonary effects of terbutaline during prolonged administration . Clin Pharmacol Ther 1982;31: 726-732.Crossref 23. Hultquist C, Lindberg C, Nyberg L, et al: Kinetics of terbutaline in asthmatic children . Eur J Respir Dis 1984;65( (suppl 134) ):195-203. 24. Nyberg L, Kennedy BM: Pharmacokinetics of terbutaline given in slow-release tablets . Eur J Respir Dis 1984;65( (suppl 134) ):119-137. 25. Billing B, Dahlqvist R, Garle M, et al: Separate and combined use of terbutaline and theophylline in asthmatics . Eur J Respir Dis 1982;63:399-409. 26. Wolfe JD, Tashkin DP, Calvarese B, et al: Bronchodilator effects of terbutaline and aminophylline alone and in combination in asthmatic patients . N Engl J Med 1978;298:363-367.Crossref

Journal

American Journal of Diseases of ChildrenAmerican Medical Association

Published: Jul 1, 1986

References