Background: Chronic obstructive pulmonary disease (COPD) greatly affects quality of life (QoL). Although QoL is a key concern for the patient, primary endpoints in most clinical trials are objective measures of disease progression.
Methods: A systematic review of double-blind randomised controlled trials was undertaken to identify data relating to the effect of tiotropium on QoL in patients with COPD.
Results: A total of 24 publications met the inclusion criteria. Compared with placebo, in the majority of studies tiotropium statistically significantly improved the St George's Respiratory Questionnaire (SGRQ) total score, although improvement beyond the accepted minimum clinically important difference (MCID) of 4 units was only achieved in three studies, all of which were of less than nine months' duration. Tiotropium also statistically significantly improved the Transition Dyspnoea Index (TDI) focal score, equating to clinically meaningful improvements, in almost all the studies that assessed TDI. In general, higher proportions of patients receiving tiotropium achieved clinically meaningful responses. The addition of other therapies (dual therapy, triple therapy) to tiotropium provided benefits that exceeded the SGRQ MCID and provided further benefit with regard to the TDI.
Conclusions: Tiotropium improves QoL for patients with COPD requiring long-acting bronchodilators, with other additional therapies providing further benefits, depending on the population.