Chest
Clinical InvestigationsCopdA 6-Month, Placebo-Controlled Study Comparing Lung Function and Health Status Changes in COPD Patients Treated With Tiotropium or Salmeterol
Section snippets
Study Design
This was a 6-month, placebo-controlled, multicenter, multinational, randomized, parallel-group study to compare the long-term efficacy of tiotropium dry-powder inhalation capsules with salmeterol inhalation aerosol in patients with COPD. The drugs were administered in a double-dummy design with tiotropium, 18 μg, or placebo capsules received once daily in the morning, and salmeterol, 50 μg, or placebo metered-dose inhaler (MDI) received twice daily (every 12 h). Capsules were administered using
Results
A total of 623 patients were entered into the trial, with 209 patients receiving tiotropium, 213 receiving salmeterol, and 201 receiving placebo. A greater proportion of patients in the tiotropium group (88%) completed the 6-month treatment period compared with the salmeterol group (83%) and the placebo group (72%). The majority of premature discontinuations were secondary to adverse events, the most frequent of which were related to underlying respiratory disease. A significantly greater
Discussion
Bronchodilators are the mainstay of pharmacotherapy for patients with COPD.123 Mechanism of action, route of administration, frequency of administration, onset of action, duration of action, symptomatic improvement, and side effect profile differentiates various bronchodilator medications. Generally, inhaled therapy has been preferred over oral therapy due to the targeted delivery to the lung, superior spirometric results, and superior tolerability. In addition, differential benefits have led
Appendix
The following investigators participated in this study: Professor D. McKenzie, Dr. E. Beck, Dr. M.V. Middle, Professor D. Ruffin, Dr. T. Schaberg, Dr. J. M. Montserrat, Professor P. Thompson, Dr. C.F. Marchioni, Dr. M. Miravitlles, Professor J. Aumann, Dr. C. Sanguinetti, Dr. J. Morera, Professor W. Vincken, Professor V. Brusasco, Dr. S.J. Langley, Dr. J. Verhaert, Dr. J.A. van Noord, Dr. R.J. White, Dr. N. Zamel, Dr. T.A. Bantje, Dr. A.J. Winning, Dr. R. Hodder, Dr. A.P.M. Greefhorst, Dr. K.R.
ACKNOWLEDGMENT
We are grateful to the patients and their families, and the coordinators, nurses, and therapists for their dedication to the study.
References (27)
- et al.
Tiotropium bromide (Ba 679 Br), a novel long-acting muscarinic antagonist for the treatment of obstructive airways disease
Life Sci
(1995) - et al.
Tiotropium (Spiriva): mechanistical considerations and clinical profile in obstructive lung disease
Life Sci
(1999) - et al.
The spirometric efficacy of once-daily dosing with tiotropium in stable COPD: a 13-week multicenter trial
Chest
(2000) - et al.
A comparison of the bronchodilating effects of salmeterol, salbutamol and ipratropium bromide in patients with chronic obstructive pulmonary disease
Pulm Pharmacol
(1995) - et al.
Efficacy of salmeterol xinafoate in the treatment of COPD
Chest
(1999) - et al.
Baseline dyspnea index and transitional dyspnea index: the measurement of dyspnea
Chest
(1984) Bronchodilator responses to anticholinergic and β-adrenergic agents in acute and stable COPD
Chest
(1991)- et al.
Standard and double dose ipratropium bromide and combined ipratropium bromide and inhaled metaproterenol in COPD
Chest
(1989) - et al.
Inhaled corticosteroids do not prevent the development of tolerance to the broncho-protective effect of salmeterol
Chest
(1996) - et al.
Rapid onset of tolerance to the bronchoprotective effect of salmeterol
Chest
(1995)
Tolerance to the protective effect of salmeterol on allergen challenge can be partially restored by the withdrawal of salmeterol regular treatment
Chest
Optimal assessment and management of chronic obstructive pulmonary disease (COPD)
Eur Respir J
Standards for the diagnosis and care of patients with chronic obstructive pulmonary disease (COPD)
Am J Respir Crit Care Med
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Drs. Donohue, van Noord, Bateman, and Langley have been consultants for Boehringer Ingelheim.
Supported by Boehringer Ingelheim Pharmaceuticals, Inc.