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Olodaterol Shows Sustained Improvements in Lung Function in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Date:9/8/2013

erol (5 and 10 mcg) delivered once daily via the Respimat® inhaler and formoterol versus placebo over the 48-week treatment period (P < 0.01).

In these studies, there was no significant difference in adverse events between the olodaterol treatment arm and the control arm with 71.0 percent of patients receiving olodaterol 5 mcg reporting an adverse event compared to 72.7 percent of patients receiving olodaterol 10 mcg, 70.8 percent of patients receiving placebo and 69.1 percent of patients receiving formoterol 12 mcg. The most common adverse reactions were nasopharyngitis, dizziness, rash and arthralgia.

Key Results from the 6-Week Phase 3 Olodaterol Studies 
In the two replicate, randomized, double-blind, placebo-controlled crossover studies, patients received olodaterol 5 mcg and 10 mcg delivered once daily via the Respimat® inhaler, tiotropium 18 mcg once daily via the HandiHaler® or placebo in addition to usual care (ICS and xanthines) for 6 weeks (n=108 and 122).

The data presented at ERS showed that the improvements seen in lung function with olodaterol, as measured by FEV1 responses, were maintained over 24 hours (P < 0.001): Study 1

Study 2FEV1 AUC0-12

response

FEV1 AUC12–24

response

FEV1 AUC0-12

response

FEV1 AUC12–24

responseOlodaterol

5

mcg

0.185 L
(P < 0.0001)

0.131 L
(P < 0.0001)

0.197 L
(P < 0.0001)

0.153 L
(P < 0.0001)Olodaterol

10

mcg

0.207 L
(P < 0.0001)

0.178 L
(P < 0.0001)

0.221 L
(P < 0.0001)

0.170 L
(P < 0.0001)Tiotropium

18

 mcg

0.173 L <
'/>"/>

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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