ABSTRACT
Currently available long-acting inhaled bronchodilators (tiotropium, salmeterol, formoterol) have demonstrated beneficial effects on exacerbations in placebo-controlled trials. However, there have been no direct comparisons of these drugs with exacerbations as the primary outcome and consequently COPD treatment guidelines do not indicate a preference for either bronchodilator. Therefore, an international, randomized, double-blind, double-dummy, parallel-group clinical trial has been designed to investigate the comparative efficacy of 2 long-acting bronchodilators tiotropium 18 microg daily and salmeterol 50 microg bid on exacerbations. The trial will include at least 6800 randomized patients with diagnosis of COPD, >or= 10 pack-year history of smoking, post-bronchodilator FEV(1) Subject(s)
Adrenergic beta-Agonists/therapeutic use
, Albuterol/analogs & derivatives
, Bronchodilator Agents/therapeutic use
, Cholinergic Antagonists/therapeutic use
, Lung/drug effects
, Pulmonary Disease, Chronic Obstructive/drug therapy
, Research Design
, Scopolamine Derivatives/therapeutic use
, Adult
, Aged
, Albuterol/therapeutic use
, Double-Blind Method
, Forced Expiratory Volume
, Humans
, Lung/physiopathology
, Middle Aged
, Pulmonary Disease, Chronic Obstructive/physiopathology
, Salmeterol Xinafoate
, Severity of Illness Index
, Time Factors
, Tiotropium Bromide
, Treatment Outcome