Spiriva (tiotropium) significantly reduced exacerbations and health care utilization in patients with Chronic Obstructive Pulmonary Disease (COPD), according to the results of a study presented at the 100th international conference of the American Thoracic Society. This is the only study with exacerbations as one of the primary endpoints performed in a large COPD patient population.
Spiriva is a novel, inhaled anticholinergic medication recommended for the first-line maintenance treatment of COPD with once-daily dosing.
COPD is a slowly progressive airway disease that causes significant deterioration of lung function and chronic breathlessness that can lead to severe disability. Currently, COPD is the fourth leading cause of death worldwide, alongside HIV/AIDS. The World Health Organization estimates that by 2020, COPD will be the third leading cause of death and the fifth leading cause of disability in the world.
The trial design had a number of characteristics making it a landmark study in COPD exacerbations: a rigorous definition of exacerbations; pre-specified co-primary endpoints of exacerbations/hospitalizations; broad patient eligibility criteria and intention-to-treat analyses for the full observation period. The study was performed in a total of 1,829 patients randomized to receive either Spiriva or placebo, both in addition to usual care, which included treatment with other bronchodilators and inhaled corticosteroids.
In this study, the addition of Spiriva to usual care significantly reduced the percentage of patients with exacerbations compared to placebo in addition to usual care (27.9 per cent vs 32.3 per cent; p=0.037) and reduced associated hospitalizations (7.0 per cent vs 9.5 per cent; p=0.056).