Short-term safety and tolerability of double-dose salmeterol/fluticasone propionate in adult asthmatic patients

Clinical Drug Investigation

Volumn 25, Issue 4, 2005, Pages 231-241

  Adolfsson, Lars Erik ^a   Lundgren, Michael ^b   Tilling, Bjorn ^a   Jern, Sverker ^c   Tyren, Christina ^d   Godwood, Alex ^d   Gor, Dee ^d  

^a Bankeryds Vårdcentral ^*  (Sweden)

^b Kvartersakuten   (Sweden)

^c SAHLGRENSKA UNIVERSITY HOSPITAL   (Sweden)

^d GLAXOSMITHKLINE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CORTICOSTEROID; FLUTICASONE PROPIONATE; FLUTICASONE PROPIONATE PLUS SALMETEROL; GLUCOSE; PLACEBO; POTASSIUM; SALBUTAMOL; SALMETEROL;

ADULT; AGED; ARTICLE; ASTHMA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORTICOSTEROID THERAPY; DETERIORATION; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE REGIMEN; DRUG SAFETY; DRUG TOLERABILITY; ELECTROCARDIOGRAM; FEMALE; FORCED EXPIRATORY FLOW; GLUCOSE BLOOD LEVEL; HEADACHE; HEART PALPITATION; HEART RATE; HOARSENESS; HUMAN; HUMAN CELL; HUMAN TISSUE; INCIDENCE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MUSCLE CRAMP; PARALLEL DESIGN; PEAK EXPIRATORY FLOW; PHARYNGITIS; POTASSIUM BLOOD LEVEL; PREDICTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; SINUS TACHYCARDIA; ST SEGMENT DEPRESSION; STATISTICAL SIGNIFICANCE; THRUSH; TREMOR;

EID: 17844391010     PISSN: 11732563     EISSN: None     Source Type: Journal    
DOI: 10.2165/00044011-200525040-00002     Document Type: Article

References (30)

1. Aubier M, Pieters W, Schlosser N, et al. Salmeterol/fluticasone propionate (50/500μg) in combination on a DISKUS inhaler (SERETIDE) is effective and safe in the treatment of steroid dependent asthma. Respir Med 1999; 93 (12): 876-84
2. Shapiro G, Lumry W, Wolfe J, et al. Combined salmeterol 50μg and fluticasone propionate 25μg in the DISKUS device for the treatment of asthma. Am J Respir Crit Care Med 2000; 161: 527-34
3. Kavuru M, Melamed J, Gross G, et al. Salmeterol and fluticasone propionate combined in a new powder inhalation device for the treatment of asthma: a randomised, double blind placebo controlled trial. J Allergy Clin Immunol 2000; 105: 1108-16
4. Global initiiative for asthma. GINA 2003. Available from URL: http//www.ginasthma.com
5. Chapman KR, Ringdal, N, et al. Salmeterol and fluticasone propionate (50/250μg) administered via a combination DISKUS inhaler: as effective as when given via separate DISKUS inhalers. Can Respir J 1999; 6: 45-51
6. Palmer JB, Stuart AM, Shepherd GL, et al. Inhaled salmeterol in the treatment of patients with moderate to severe reversible obstructive airways disease: a 3 month comparison of the efficacy and safety of twice daily salmeterol (100μg) with salmeterol (50μg). Respir Med 1992; 86: 409-17
7. Dahl R, Earnshaw JS, Palmer JBD. Salmeterol: a four week study of a long-acting beta-adrenoceptor agonist for the treatment of reversible airways disease. Eur Respir J 1991; 4: 1178-84
8. Shrewsbury S, Hallett C. Salmeterol 100 μg: an analysis of its tolerability in single and chronic dose studies. Ann Allergy Asthma Immunol 2001; 87: 465-73
9. British Thoracic Society, Scottish Intercollegiate Guidelines network. British guideline on the management of asthma. Thorax 2003; 58 Suppl. 1: 1-94
10. Harrison TW, Oborne J, Newton S, et al. Doubling the dose of inhaled corticosteroid to prevent asthma exacerbations: randomised controlled trial. Lancet 2004; 363: 271-5
11. Foresi A, Morelli MC, Catena E, Low-dose budesonide with the addition of an increased dose during exacerbations is effective in long-term asthma control. Chest 2000; 117: 440-6
12. Crane J, Burgess C, Beasley R. Cardiovascular and hypokalaemic effects of inhaled salbutamol, fenoterol and isoprenaline. Thorax 1989; 44: 136-40
13. Flatt A, Crane J, Purdic G, et al. The cardiovascular effects of beta adrenergic agonist drugs administered by nebulization. Postgrad Med J 1990; 66: 98-101
14. Brogden RN, Faulds, D. Salmeterol xinafoate: a review of its pharmacological properties and therapeutic potential in reversible obstructive airways disease. Drugs 1991; 42 (5): 895-912
15. Pearlman DS, Chervinsky P, LaForce C, et al. Comparison of salmeterol with albuterol in the treatment of mild to moderate asthma. N Engl J Med 1992; 327: 1420-5
16. D'Lonzo GE, Nathan RA, Henochowicz S, et al. Salmeterol xinafoate as maintenance therapy with albuterol in patients with asthma. JAMA 1994; 271: 1412-6
17. Britton MG, Earnshaw JS, Palmer JB. A 12-month comparison of salmeterol with salbutamol in asthmatic patients. Eur Respir J 1992; 5: 1062-7
18. Kemp JP, Bierman CW, Cocchetto DM. Dose-response study of inhaled salmeterol in asthmatic patients with 24-hour spirometry and Holter monitoring. Ann Allergy 1993; 70: 316-22
19. Sandström T, Frederiksen B, Rosenhall L, et al. Salmeterol: a dose response study with a long acting inhaled β2-agonist [abstract]. Am Rev Respir Dis 1989; 139: A64
20. 2 adrenoceptor agonist: a comparison with salbutamol in adult asthmatic patients. Thorax 1988; 43 (9): 674-8
21. Maconochie JG, Forster JK. Dose-response study with high-dose inhaled salmeterol in healthy subjects. Br J Clin Pharmacol 1992; 33 (3): 342-5
22. Boyd G, Morice AH, Pounsford JC, et al. An evaluation of salmeterol in the treatment of chronic obstructive pulmonary disease (COPD). Eur Respir J 1997; 10: 815-21
23. Maconchie JG, Minton NA, Chilton JE, et al. Does tachyphylaxis occur to the non-pulmonary effects of salmeterol? Br J Clin Pharmacol 1994; 37 (2): 199-204
24. Bennett JA, Smyth ET, Pavord ID, et al. Systemic effects of salbutamol and salmeterol in patients with asthma. Thorax 1994; 49: 771-4
25. Barnes PJ, Pedersen S. Efficacy and safety of inhaled corticosteroids in asthma. Am Rev Respir Dis 1993; 148 Suppl. 1: S1-26
26. Ayres JG, Bateman ED, Lundback B, et al. High dose fluticasone propionate 1mg daily vs. fluticasone propionate 2mg daily, or budesonide 1.6mg daily, in patients with chronic severe asthma. Eur Respir J 1995; 8: 579-86
27. Leblanc P, Mink P, Keistinen T, et al. A comparison of fluticasone propionate 200μg/day with beclomethasone dipropionate 400μg/day in adult asthma. Allergy 1994; 49: 380-5
28. Lündback B, Alexander M, Day J, et al. Evaluation of fluticasone propionate (500μg day) administered either as a dry powder via a Diskhaler® inhaler or pressurized inhaler and compared with beclomethasone dipropionate (1000μg day) administered by pressurized inhaler. Respir Med 1993; 87: 609-20
29. Lorentzen KA, van Helmond JLM, Bauer K, et al. Fluticasone propionate 1mg daily and beclomethasone dipropionate 2mg daily: a comparison over 1 year. Respir Med 1996; 90: 609-17
30. Pedersen S, Byrne PA. A comparison of the efficacy and safety of inhaled corticosteroids in asthma. Allergy 1997; 52 Suppl. 39: 1-34