Tiotropium in Combination with Placebo, Salmeterol, or Fluticasone–Salmeterol for Treatment of Chronic Obstructive Pulmonary Disease

A Randomized Trial

View larger version (67K): [in this window] [in a new window]   Figure 1. Study flow chart.

View larger version (23K): [in this window] [in a new window]   Figure 2. Kaplan–Meier estimates of the probability of remaining free of exacerbations, according to treatment assignment. The unadjusted hazard ratio was 1.02 (95% CI, 0.77 to 1.37) for tiotropium plus placebo versus tiotropium plus salmeterol (P = 0.87) and 0.80 (CI, 0.60 to 1.08) for tiotropium plus placebo versus tiotropium plus fluticasone–salmeterol (P = 0.15). COPD = chronic obstructive pulmonary disease.

View larger version (22K): [in this window] [in a new window]   Figure 3. Changes in health-related quality of life and FEV1 over 1 year. Top. Scores on the St. George's Respiratory Questionnaire (SGRQ). Lower scores indicate improvements in quality of life. P = 0.02 for tiotropium plus placebo versus tiotropium plus salmeterol at 52 weeks; P = 0.01 for tiotropium plus placebo versus tiotropium plus fluticasone–salmeterol at 52 weeks. Bottom. Mean prebronchodilator FEV1. P = 0.87 tiotropium plus placebo versus tiotropium plus salmeterol at 52 weeks; P = 0.049 tiotropium plus placebo versus tiotropium plus fluticasone–salmeterol at 52 weeks.