| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
|
|
|
|||||||
|
|||||||||
Clinical Trial |
The objective of the present study was to investigate the dose-dependent bronchodilator efficacy and duration of action of the newly developed antimuscarinic agent tiotropium bromide in patients with chronic obstructive pulmonary disease (COPD). In a randomized, double-blind, placebo-controlled, crossover design, patients inhaled single doses of 10-80 micrograms tiotropium bromide and placebo, formulated in lactose powder capsules. The washout period between test doses was 72 h. Thirty five patients were enrolled in the trial (32 males and 3 females; mean age 64 yrs). Baseline forced expiratory volume in one second (FEV1) (mean 1.34 L) was less than 65% of predicted and was < 70% of forced vital capacity (FVC). All subjects had a smoking history of more than 10 pack-years. The mean reversibility of FEV1 after inhalation of 40 micrograms ipratropium bromide was 28%. Pulmonary function testing was performed before and at regular time intervals for up to 32 h after test drug administration. Compared to placebo, tiotropium bromide produced significant improvements in FEV1, FVC, peak expiratory flow rate (PEFR) and forced mid-expiratory flow (FEF25-75%). The bronchodilator response was almost immediate; peak improvement in FEV1 was reached 1-4 h after test drug inhalation, and the duration of action extended to 32 h after the 20, 40 and 80 micrograms doses. A clear dose-response relationship was seen for peak FEV1 and for the average FEV1 over differing time periods during the 32 h observation period, 80 micrograms of test drug being superior to the 10 micrograms dose. Peak improvement in FEV1 ranged 19-26% of test-day baseline for tiotropium bromide doses compared to 16% for placebo. The large improvement for placebo is probably due to carry-over effect which was significant. After excluding carry-over effect, the peak response to placebo decreased to 11%, whilst for tiotropium bromide doses it ranged 20-25%; standard error for mean difference was about 4%. There was no evidence of systemic anticholinergic effects. In this population of patients with COPD, tiotropium bromide was found to be a safe and long-acting bronchodilator, demonstrating a clear dose-response relationship following single dose administration.
This article has been cited by other articles:
|
|
 |
|
  S. Kesten, M. Jara, C. Wentworth, and S. Lanes Pooled Clinical Trial Analysis of Tiotropium Safety Chest, December 1, 2006; 130(6): 1695 - 1703. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 R G Barr, J Bourbeau, C A Camargo, and F S F Ram Tiotropium for stable chronic obstructive pulmonary disease: a meta-analysis Thorax, October 1, 2006; 61(10): 854 - 862. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 G. M. Turino Therapeutic Gains of Prolonged Bronchial Dilatation in Chronic Obstructive Pulmonary Disease Ann Intern Med, September 6, 2005; 143(5): 386 - 387. [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]
|
|
|
|
 |
|
 H. Somand and T. L Remington Tiotropium: A Bronchodilator for Chronic Obstructive Pulmonary Disease Ann. Pharmacother., September 1, 2005; 39(9): 1467 - 1475. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 J. A. van Noord, J-L. Aumann, E. Janssens, J. J. Smeets, J. Verhaert, B. Disse, A. Mueller, and P. J. G. Cornelissen Comparison of tiotropium once daily, formoterol twice daily and both combined once daily in patients with COPD Eur. Respir. J., August 1, 2005; 26(2): 214 - 222. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
N. J. Gross Tiotropium Bromide Chest, December 1, 2004; 126(6): 1946 - 1953. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
W.T. McNicholas, P.M.A. Calverley, A. Lee, and J.C. Edwards Long-acting inhaled anticholinergic therapy improves sleeping oxygen saturation in COPD Eur. Respir. J., June 1, 2004; 23(6): 825 - 831. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. Hasani, N. Toms, J. E. Agnew, M. Sarno, A. J. Harrison, and P. Dilworth The Effect of Inhaled Tiotropium Bromide on Lung Mucociliary Clearance in Patients With COPD Chest, May 1, 2004; 125(5): 1726 - 1734. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
P M A Calverley, A Lee, L Towse, J van Noord, T J Witek, and S Kelsen Effect of tiotropium bromide on circadian variation in airflow limitation in chronic obstructive pulmonary disease Thorax, October 1, 2003; 58(10): 855 - 860. [Abstract] [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]
|
|
|
|
|
|
J.A. van Noord, J.J. Smeets, F.L.J. Custers, L. Korducki, and P.J.G. Cornelissen Pharmacodynamic steady state of tiotropium in patients with chronic obstructive pulmonary disease Eur. Respir. J., April 1, 2002; 19(4): 639 - 644. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
W. Vincken, J.A. van Noord, A.P.M. Greefhorst, Th.A. Bantje, S. Kesten, L. Korducki, and P.J.G. Cornelissen Improved health outcomes in patients with COPD during 1 yr's treatment with tiotropium Eur. Respir. J., February 1, 2002; 19(2): 209 - 216. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
R. Casaburi, D.A. Mahler, P.W. Jones, A. Wanner, G. San Pedro, R.L. ZuWallack, S.S. Menjoge, C.W. Serby, and T. Witek Jr A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease Eur. Respir. J., February 1, 2002; 19(2): 217 - 224. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 H. P Wiedemann Tiotropium improved lung function more than ipratropium in chronic obstructive pulmonary disease Evid. Based Med., November 1, 2000; 5(6): 169 - 169. [Full Text]
|
|
|
|
|
|
R. Casaburi, D. D. Briggs Jr., J. F. Donohue, C. W. Serby, S. S. Menjoge, and T. J. Witek Jr. The Spirometric Efficacy of Once-Daily Dosing With Tiotropium in Stable COPD : A 13-Week Multicenter Trial Chest, November 1, 2000; 118(5): 1294 - 1302. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 M. R. LITTNER, J. S. ILOWITE, D. P. TASHKIN, M. FRIEDMAN, C. W. SERBY, S. S. MENJOGE, and T. J. WITEK Jr. Long-Acting Bronchodilation with Once-Daily Dosing of Tiotropium (Spiriva) in Stable Chronic Obstructive Pulmonary Disease Am. J. Respir. Crit. Care Med., April 1, 2000; 161(4): 1136 - 1142. [Abstract] [Full Text]
|
|
|
|
|
|
J A van Noord, T A Bantje, M E Eland, L Korducki, and P J G Cornelissen A randomised controlled comparison of tiotropium and ipratropium in the treatment of chronic obstructive pulmonary disease Thorax, April 1, 2000; 55(4): 289 - 294. [Abstract] [Full Text]
|
|
|
|
|
|
P. J. Barnes The Pharmacological Properties of Tiotropium Chest, February 1, 2000; 117(2_suppl): 63S - 66S. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
P. J. BARNES Novel Approaches and Targets for Treatment of Chronic Obstructive Pulmonary Disease Am. J. Respir. Crit. Care Med., November 1, 1999; 160(5): S72 - 79. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
R. J. Martin, B. L. Bucher Bartelson, P. Smith, D. W. Hudgel, D. Lewis, G. Pohl, P. Koker, and J. F. Souhrada Effect of Ipratropium Bromide Treatment on Oxygen Saturation and Sleep Quality in COPD Chest, May 1, 1999; 115(5): 1338 - 1345. [Abstract] [Full Text] [PDF]
|
|
| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
