|
|
||||||||
Clinical Trial |
The objectives of this study were to compare the efficacy and safety of salmeterol xinafoate (50 and 100 microg b.i.d.) with that of placebo, when added to existing therapy, in the treatment of patients with chronic obstructive pulmonary disease (COPD). Six hundred and seventy four patients were randomized to receive either salmeterol 50 microg b.i.d., salmeterol 100 microg b.i.d., or placebo treatment for a period of 16 weeks. The results showed a significant improvement in daily symptom scores noted for patients taking either 50 microg (p=0.043) or 100 microg b.i.d. salmeterol (p=0.01) compared with placebo, with a corresponding decrease in additional daytime salbutamol requirements for both salmeterol groups. The same pattern was reflected for night-time symptoms and additional salbutamol use. During treatment, forced expiratory volume in one second (FEV1) measurements improved significantly in each salmeterol group, with up to a 7% improvement observed at the end of the study. Although no difference was observed between treatment groups for the distance walked in 6 min, patients treated with salmeterol 50 microg b.i.d. were significantly less breathless than those treated with placebo after their 6 min walk, after 8 weeks (p=0.024) and 16 weeks (p=0.004) of therapy. Adverse events were similar in all three groups except for tremor, which was significantly higher in the 100 microg b.i.d. salmeterol group (p=0.005) compared both with 50 microg b.i.d. salmeterol and placebo. Salmeterol offered further positive improvement to the effect of therapy in patients with chronic obstructive pulmonary disease when added to their existing regimens. This clinical improvement was similar both with 50 and 100 microg b.i.d. dosage, although the group receiving 50 microg b.i.d. tolerated the drug better than those receiving 100 microg b.i.d. salmeterol.
This article has been cited by other articles:
![]() |
G. J. Rodrigo, L. J. Nannini, and R. Rodriguez-Roisin Safety of Long-Acting {beta}-Agonists in Stable COPD: A Systematic Review Chest, May 1, 2008; 133(5): 1079 - 1087. [Abstract] [Full Text] [PDF] |
||||
![]() |
C. Brouillard, V. Pepin, J. Milot, Y. Lacasse, and F. Maltais Endurance shuttle walking test: responsiveness to salmeterol in COPD Eur. Respir. J., March 1, 2008; 31(3): 579 - 584. [Abstract] [Full Text] [PDF] |
||||
![]() |
T. J. Wilt, D. Niewoehner, R. MacDonald, and R. L. Kane Management of Stable Chronic Obstructive Pulmonary Disease: A Systematic Review for a Clinical Practice Guideline Ann Intern Med, November 6, 2007; 147(9): 639 - 653. [Abstract] [Full Text] [PDF] |
||||
![]() |
N. A. Hanania and J. F. Donohue Pharmacologic Interventions in Chronic Obstructive Pulmonary Disease: Bronchodilators Proceedings of the ATS, October 1, 2007; 4(7): 526 - 534. [Abstract] [Full Text] [PDF] |
||||
![]() |
V. Pepin, J. Brodeur, Y. Lacasse, J. Milot, P. LeBlanc, F. Whittom, and F. Maltais Six-minute walking versus shuttle walking: responsiveness to bronchodilation in chronic obstructive pulmonary disease Thorax, April 1, 2007; 62(4): 291 - 298. [Abstract] [Full Text] [PDF] |
||||
![]() |
D. E. O'Donnell Impacting patient-centred outcomes in COPD: breathlessness and exercise tolerance Eur. Respir. Rev., December 1, 2006; 15(99): 37 - 41. [Abstract] [Full Text] [PDF] |
||||
![]() |
M. Decramer Tiotropium as essential maintenance therapy in COPD Eur. Respir. Rev., December 1, 2006; 15(99): 51 - 57. [Abstract] [Full Text] [PDF] |
||||
![]() |
A. O. D'Souza, M. J. Smith, L. A. Miller, and J. Kavookjian An Appraisal of Pharmacoeconomic Evidence of Maintenance Therapy for COPD Chest, June 1, 2006; 129(6): 1693 - 1708. [Abstract] [Full Text] [PDF] |
||||
![]() |
S Scott, P Walker, and P M A Calverley COPD exacerbations {middle dot} 4: Prevention Thorax, May 1, 2006; 61(5): 440 - 447. [Abstract] [Full Text] [PDF] |
||||
![]() |
V. Pepin, D. Saey, F. Whittom, P. LeBlanc, and F. Maltais Walking versus Cycling: Sensitivity to Bronchodilation in Chronic Obstructive Pulmonary Disease Am. J. Respir. Crit. Care Med., December 15, 2005; 172(12): 1517 - 1522. [Abstract] [Full Text] [PDF] |
||||
![]() |
A. Ek, L. Palmberg, B.-M. Sundblad, and K. Larsson Salmeterol Does Not Alter Increased Bronchial Responsiveness Caused by Organic Dust Exposure Chest, October 1, 2005; 128(4): 3038 - 3047. [Abstract] [Full Text] [PDF] |
||||
![]() |
W. Vincken Bronchodilator treatment of stable COPD: long-acting anticholinergics Eur. Respir. Rev., September 1, 2005; 14(94): 23 - 31. [Abstract] [Full Text] [PDF] |
||||
![]() |
E F M Wouters, D S Postma, B Fokkens, W C J Hop, J Prins, A F Kuipers, H R Pasma, C A J Hensing, E C Creutzberg, and for the COSMIC (COPD and Seretide: a Multi-Center Withdrawal of fluticasone propionate from combined salmeterol/fluticasone treatment in patients with COPD causes immediate and sustained disease deterioration: a randomised controlled trial Thorax, June 1, 2005; 60(6): 480 - 487. [Abstract] [Full Text] [PDF] |
||||
![]() |
J Vestbo, R Pauwels, J A Anderson, P Jones, P Calverley, and on behalf of the TRISTAN study group Early onset of effect of salmeterol and fluticasone propionate in chronic obstructive pulmonary disease Thorax, April 1, 2005; 60(4): 301 - 304. [Abstract] [Full Text] [PDF] |
||||
![]() |
M Decramer, R Gosselink, P Bartsch, C-G Lofdahl, W Vincken, R Dekhuijzen, J Vestbo, R Pauwels, R Naeije, and T Troosters Effect of treatments on the progression of COPD: report of a workshop held in Leuven, 11-12 March 2004 Thorax, April 1, 2005; 60(4): 343 - 349. [Abstract] [Full Text] [PDF] |
||||
![]() |
D.E. O'Donnell, N. Voduc, M. Fitzpatrick, and K.A. Webb Effect of salmeterol on the ventilatory response to exercise in chronic obstructive pulmonary disease Eur. Respir. J., July 1, 2004; 24(1): 86 - 94. [Abstract] [Full Text] [PDF] |
||||
![]() |
D.E. O'Donnell, T. Fluge, F. Gerken, A. Hamilton, K. Webb, B. Aguilaniu, B. Make, and H. Magnussen Effects of tiotropium on lung hyperinflation, dyspnoea and exercise tolerance in COPD Eur. Respir. J., June 1, 2004; 23(6): 832 - 840. [Abstract] [Full Text] [PDF] |
||||
![]() |
B J Smith, S L Appleton, A J Veale, H J McElroy, D Veljkovic, and L Saccoia Eformoterol n-of-1 trials in chronic obstructive pulmonary disease poorly reversible to salbutamol Chronic Respiratory Disease, April 1, 2004; 1(2): 63 - 69. [Abstract] [PDF] |
||||
![]() |
D. P. Tashkin and C. B. Cooper The Role of Long-Acting Bronchodilators in the Management of Stable COPD Chest, January 1, 2004; 125(1): 249 - 259. [Abstract] [Full Text] [PDF] |
||||
![]() |
M. Decramer Treatment of chronic respiratory failure: lung volume reduction surgery versus rehabilitation Eur. Respir. J., November 16, 2003; 22(47_suppl): 47s - 56s. [Abstract] [Full Text] [PDF] |
||||
![]() |
G. T. Ferguson, C. Funck-Brentano, T. Fischer, P. Darken, and C. Reisner Cardiovascular Safety of Salmeterol in COPD Chest, June 1, 2003; 123(6): 1817 - 1824. [Abstract] [Full Text] [PDF] |
||||
![]() |
W MacNee and P M A Calverley Chronic obstructive pulmonary disease * 7: Management of COPD Thorax, March 1, 2003; 58(3): 261 - 265. [Abstract] [Full Text] [PDF] |
||||
![]() |
W. Szafranski, A. Cukier, A. Ramirez, G. Menga, R. Sansores, S. Nahabedian, S. Peterson, and H. Olsson Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease Eur. Respir. J., January 1, 2003; 21(1): 74 - 81. [Abstract] [Full Text] [PDF] |
||||
![]() |
M. Wadbo, C-G. Lofdahl, K. Larsson, B.E. Skoogh, G. Tornling, E. Arwestrom, T. Bengtsson, and K. Strom Effects of formoterol and ipratropium bromide in COPD: a 3-month placebo-controlled study Eur. Respir. J., November 1, 2002; 20(5): 1138 - 1146. [Abstract] [Full Text] [PDF] |
||||
![]() |
P.M.A. Calverley Medical therapy for COPD: lessons from the real world Eur. Respir. J., October 1, 2002; 20(4): 797 - 798. [Full Text] [PDF] |
||||
![]() |
J. F. Donohue, J. A. van Noord, E. D. Bateman, S. J. Langley, A. Lee, T. J. Witek Jr, S. Kesten, and L. Towse A 6-Month, Placebo-Controlled Study Comparing Lung Function and Health Status Changes in COPD Patients Treated With Tiotropium or Salmeterol* Chest, July 1, 2002; 122(1): 47 - 55. [Abstract] [Full Text] [PDF] |
||||
![]() |
R. Aalbers, J. Ayres, V. Backer, M. Decramer, P.A. Lier, P. Magyar, J. Malolepszy, R. Ruffin, and G.W. Sybrecht Formoterol in patients with chronic obstructive pulmonary disease: a randomized, controlled, 3-month trial Eur. Respir. J., May 1, 2002; 19(5): 936 - 943. [Abstract] [Full Text] [PDF] |
||||
![]() |
J. J. W. Liesker, P. J. Wijkstra, N. H. T. Ten Hacken, G. H. Koeter, D. S. Postma, and H. A. M. Kerstjens A Systematic Review of the Effects of Bronchodilators on Exercise Capacity in Patients With COPD Chest, February 1, 2002; 121(2): 597 - 608. [Abstract] [Full Text] [PDF] |
||||
![]() |
R. DAHL, L. A. P. M. GREEFHORST, D. NOWAK, V. NONIKOV, A. M. BYRNE, M. H. THOMSON, D. TILL, and G. DELLA CIOPPA Inhaled Formoterol Dry Powder Versus Ipratropium Bromide in Chronic Obstructive Pulmonary Disease Am. J. Respir. Crit. Care Med., September 1, 2001; 164(5): 778 - 784. [Abstract] [Full Text] [PDF] |
||||
![]() |
M. Johnson and S. Rennard Alternative Mechanisms for Long-Acting {beta}2-Adrenergic Agonists in COPD Chest, July 1, 2001; 120(1): 258 - 270. [Abstract] [Full Text] [PDF] |
||||
![]() |
M.L. Ayers, R. Mejia, J. Ward, T. Lentine, and D.A. Mahler Effectiveness of salmeterol versus ipratropium bromide on exertional dyspnoea in COPD Eur. Respir. J., June 1, 2001; 17(6): 1132 - 1137. [Abstract] [Full Text] [PDF] |
||||
![]() |
R. L. ZuWallack, D. A. Mahler, D. Reilly, N. Church, A. Emmett, K. Rickard, and K. Knobil Salmeterol Plus Theophylline Combination Therapy in the Treatment of COPD Chest, June 1, 2001; 119(6): 1661 - 1670. [Abstract] [Full Text] [PDF] |
||||
![]() |
M.-F. Beauchesne Management of Chronic Obstructive Pulmonary Disease: A Review Journal of Pharmacy Practice, April 1, 2001; 14(2): 126 - 142. [Abstract] [PDF] |
||||
![]() |
S. I. RENNARD, W. ANDERSON, R. ZuWALLACK, J. BROUGHTON, W. BAILEY, M. FRIEDMAN, M. WISNIEWSKI, and K. RICKARD Use of a Long-acting Inhaled {beta}2-Adrenergic Agonist, Salmeterol Xinafoate, in Patients with Chronic Obstructive Pulmonary Disease Am. J. Respir. Crit. Care Med., April 1, 2001; 163(5): 1087 - 1092. [Abstract] [Full Text] |
||||
![]() |
F. M. V. Boueri, B. L. Bucher-Bartelson, K. A. Glenn, and B. J. Make Quality of Life Measured With a Generic Instrument (Short Form-36) Improves Following Pulmonary Rehabilitation in Patients With COPD Chest, January 1, 2001; 119(1): 77 - 84. [Abstract] [Full Text] [PDF] |
||||
![]() |
M. Cazzola, G. Di Lorenzo, F. Di Perna, F. Calderaro, R. Testi, and S. Centanni Additive Effects of Salmeterol and Fluticasone or Theophylline in COPD Chest, December 1, 2000; 118(6): 1576 - 1581. [Abstract] [Full Text] [PDF] |
||||
![]() |
P. J. Barnes Chronic Obstructive Pulmonary Disease N. Engl. J. Med., July 27, 2000; 343(4): 269 - 280. [Full Text] [PDF] |
||||
![]() |
M. Rudolf The Reality of Drug Use in COPD : The European Perspective Chest, February 1, 2000; 117(2_suppl): 29S - 32S. [Abstract] [Full Text] [PDF] |
||||
![]() |
M. G. Pearson How Can the Implementation of Guidelines Be Improved? Chest, February 1, 2000; 117(2_suppl): 38S - 41S. [Abstract] [Full Text] [PDF] |
||||
![]() |
T. L. Petty, D. A. Mahler, J. F. Donohue, and K. A. Rickard Apples and Oranges : Flaws and Guffaws Chest, October 1, 1999; 116(4): 1137 - 1138. [Full Text] [PDF] |
||||
![]() |
H. A M Kerstjens Clinical evidence: Stable chronic obstructive pulmonary disease BMJ, August 21, 1999; 319(7208): 495 - 500. [Full Text] |
||||
![]() |
M. Cazzola, C. F. Donner, and M. G. Matera Long acting beta 2 agonists and theophylline in stable chronic obstructive pulmonary disease Thorax, August 1, 1999; 54(8): 730 - 736. [Full Text] |
||||
![]() |
D. A. Mahler, J. F. Donohue, R. A. Barbee, M. D. Goldman, N. J. Gross, M. E. Wisniewski, S. W. Yancey, B. A. Zakes, K. A. Rickard, and W. H. Anderson Efficacy of Salmeterol Xinafoate in the Treatment of COPD Chest, April 1, 1999; 115(4): 957 - 965. [Abstract] [Full Text] [PDF] |
||||
| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |