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Olodaterol, a new once-daily inhaled long-acting beta agonist, improved lung function and exercise capacity in chronic obstructive pulmonary disease (COPD) in two randomized trials (n=199) presented by Gregory Feldman et al at the Chest 2013 meeting in Chicago.
The new once-daily LABA olodaterol will reportedly be marketed by Boehringer Ingelheim under the trade name Striverdi Respimat.
Both trials had identical designs and compared olodaterol against formoterol and placebo for 6 weeks. Olodaterol was significantly better than placebo at improving forced expiratory volume over 1 second (FEV1) in both studies.
Compared to formoterol, olodaterol performed equally well over the first 12 hours (both bronchodilators improved FEV1 by about 150 mL). Olodaterol was less effective than formoterol between 12 and 24 hours (after the formoterol group took their evening dose), with FEV1s about 50 mL lower than the formoterol group's during this period.
At six weeks, the two trials showed olodaterol improved exercise capacity compared to placebo as well, with people able to exercise about 30-60 seconds longer at 75% capacity after taking olodaterol (about 10-15% longer than placebo users).
Prior year-long phase III trials (not yet published) also showed benefits of olodaterol in COPD. Olodaterol's bronchodilator effects were modest when added to other therapies -- trough FEV1 improvements of about 75 mL over placebo, peaks ~175 mL greater than placebo. An FDA advisory panel saw benefit and voted 15-1 to approve olodaterol, but the full FDA has not yet done so, citing manufacturing issues. There were no safety issues noted or serious adverse events in trials of olodaterol.
Other news from the billion-dollar worlds of COPD and asthma inhalers:
- A once-daily inhaler combining oloadaterol and tiotropium for COPD is in the works.
- A competing LABA (indacaterol) and long-acting anticholingergic (glycopyrronium) is under development as well.
- Once-daily LABA/inhaled corticosteroid combinations are coming soon; the first (Breo Ellipta) was approved in 2013 by the FDA for treatment of COPD.