TUESDAY, Oct. 13 (HealthDay News) -- In patients with chronic obstructive pulmonary disease (COPD), triple therapy with budesonide/formoterol added to tiotropium significantly improves lung function and reduces severe exacerbations compared to monotherapy with tiotropium, according to a study published in the Oct. 15 issue of the American Journal of Respiratory and Critical Care Medicine.

Tobias Welte, M.D., of the Hannover Medical School in Germany, and colleagues randomly assigned 660 patients (mean age, 62 years) with a mean forced expiratory volume in one second of 1.1 liters to receive 18 µg of tiotropium once daily in addition to either budesonide/formoterol (320/9 µg) or placebo twice daily.

After 12 weeks, the researchers found that triple therapy significantly increased pre- and post-dose forced expiratory volume in one second (6 and 11 percent, respectively) compared to tiotropium alone. They also found that triple therapy was associated with a 62 percent decrease in severe exacerbations, and significant improvements in morning lung function, morning symptoms, reliever use, and ability to perform morning activities.

"The study by Welte and colleagues has very usefully confirmed the benefits of ICS+LABA [inhaled corticosteroid plus long-acting β₂-agonist] when used in addition to tiotropium in patients with severe airway obstruction, but perhaps this chapter in the history of clinical trials in COPD should now be closed," states the author of an accompanying editorial. "Future prospective studies of ICS+LABA should include a large proportion of a highly neglected group of patients -- those with mild to moderate obstruction."

This study was supported by AstraZeneca; several authors of the study and editorial reported financial relationships with the company and other pharmaceutical companies.

Abstract
Full Text (subscription or payment may be required)
Editorial (subscription or payment may be required)