Clinical Question: In men with chronic obstructive pulmonary disease (COPD), does daily treatment with tiotropium (Spiriva) decrease the frequency of exacerbations?

Setting: Outpatient (any)

Study Design: Randomized controlled trial (double-blinded)

Allocation: Uncertain

Synopsis: Tiotropium is a once-daily inhaled anticholinergic bronchodilator. To evaluate its effectiveness in the treatment of COPD, the investigators enrolled 1,829 men with moderate to severe disease, with a mean forced expiratory volume in one second (FEV₁) of 36 percent predicted. The men were 40 years or older and all had an FEV₁ of less than 60 percent predicted and were taking less than 20 mg of prednisone daily. The patients were randomized to receive an inhaler delivering placebo or 18 mcg tiotropium, to be used daily for six months. Allocation to treatment may not have been concealed from the enrolling investigators. Patients continued their usual medical care. Dropout rates were high: 27 percent in the placebo group, and 16 percent in the active treatment group, primarily caused by worsening of symptoms. The percentage of patients experiencing an exacerbation of COPD during the six months was slightly lower (but statistically significant) in the treated patients (27.9 versus 32.3 percent; P = .037). In this study, one less patient experienced an exacerbation for every 23 patients treated with tiotropium instead of placebo (number needed to treat = 22.7; 95% confidence interval, 12 to 456), but the number of patients who need to be treated could be much higher (n = 456). The number of patients requiring hospitalization because of COPD exacerbation was not significantly different between the two groups.

Bottom Line: Daily treatment with tiotropium for six months slightly decreases the number of patients experiencing a COPD exacerbation, but it does not decrease the number of patients who will be hospitalized for an exacerbation. (Level of Evidence: 1b–)