The study recruited 5,993 patients with an average age of 65 and a diagnosis of chronic obstructive pulmonary disease (COPD). They were randomised to treatment with placebo or tiotropium and followed up for 4 years. All other medication was allowed with the exception of inhaled anticholinergic drugs.
At the end of the study there was no difference in the primary endpoint of the rate of decline in the mean FEV1. Some differences were noted in secondary outcomes but these should be viewed with caution when the primary endpoint failed to reach significance.
The differences noted include improved responses to the St. George's Respiratory Questionnaire and reductions in exacerbations and hospital admissions. The authors conclude that, "therapy with tiotropium was associated with improvements in lung function", but "did not significantly reduce the rate of decline in FEV1".
Action: Tiotropium does not appear to preserve lung function in patients with COPD. Additional studies would be required to confirm whether the differences noted in the secondary outcomes are real.