Olodaterol Improves Lung Function in Patients With COPD
Phase III data presented at European respiratory congress (September 8)
Phase III data presented at the European Respiratory Society (ERS) Annual Congress 2013 in Barcelona have shown that the addition of olodaterol 5 or 10 mcg, delivered once daily via the Respimat inhaler (Boehringer Ingelheim), provided improvements in lung function in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).
Olodaterol is an investigational long-acting beta agonist (LABA) currently being studied as a once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.
Patients participating in the olodaterol phase III clinical program were allowed to continue their usual care, with the exception of LABAs. Usual care included long- and short-acting anticholinergics, short-acting beta agonists, inhaled corticosteroids (ICS), and xanthines.
In two 48-week phase III pivotal studies, olodaterol 5 or 10 mcg, delivered once daily via the Respimat inhaler, provided statistically significant improvements in lung function, as measured by forced expiratory volume in 1 second (FEV1) versus placebo plus usual care in a total of 1,284 patients with moderate to very severe COPD (P < 0.05).
In a second set of two 48-week studies, the same dose and delivery of olodaterol provided comparable improvements in lung function compared with formoterol 12 mcg twice daily in a total of 1,838 COPD patients. After 24 weeks of treatment, both doses of olodaterol and formoterol provided statistically significant improvements in the FEV1 area under the curve (AUC0–3).
In two randomized, double-blind, placebo-controlled crossover studies, a total of 230 patients with COPD received olodaterol 5 or 10 mcg, delivered once daily via the Respimat inhaler; tiotropium 18 mcg, delivered once daily via the HandiHaler; or placebo in addition to usual care (ICS and xanthines) for 6 weeks. Improvements in lung function with olodaterol, as measured by FEV1 responses, were maintained over 24 hours (P < 0.001).
Source: Boehringer Ingelheim; September 8, 2013.