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

A Randomized Trial


Figure 1
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  		Figure 1. Study flow diagram.

COPD = chronic obstructive pulmonary disease.

 

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  		Table 1. Baseline Characteristics

 

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  		Table 2. Exacerbations of Chronic Obstructive Pulmonary Disease and Health Care Utilization during 1 Year*

 

Figure 2
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  		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.

 

Figure 3
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  		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 for tiotropium plus placebo versus tiotropium plus salmeterol at 52 weeks; P = 0.049 for tiotropium plus placebo versus tiotropium plus fluticasone–salmeterol at 52 weeks.

 

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  		Table 3. Mortality and Adverse Event Rates

 



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