Comparison Of 24-Hour FEV1 Profile For Once-Daily Versus Twice-Daily Treatment With Olodaterol, A Novel Long-Acting B2-Agonist, In Patients With COPD

Lung function efficacy and symptomatic benefit of olodaterol once daily delivered via Respimat® versus placebo and formoterol twice daily in patients with GOLD 2–4 COPD: results from two replicate 48-week studies

“…The results of these pivotal 48-week studies build on the evidence provided by the Phase II studies15,26 and are in line with those observed for the other set of pivotal replicate studies (NCT00782210; NCT00782509), which also demonstrated significantly improved lung function with olodaterol versus placebo. The available data for olodaterol create a comprehensive bank of evidence indicating that both 5 and 10 μg achieve 24-hour bronchodilation that provides benefits in lung function with an acceptable safety profile in a population of patients considered to closely represent those in clinical practice 14,27–32.…”

The 24 Hour Lung Function Time Profile of Olodaterol Once Daily Versus Placebo and Tiotropium in Patients with Moderate to Very Severe Chronic Obstructive Pulmonary Disease

“…Further support is available from earlier phase II studies using the same primary end points, demonstrating that olodaterol 5 and 10 μg administered QD provide significant and identical bronchodilation over the complete 24 hour dosing period [5,7].…”

“…The doses of olodaterol evaluated in the phase III program (5 and 10 µg QD) were based on the results of two phase II studies [7,10]. As part of the phase III evaluation, the two replicate studies presented here were designed to evaluate the 24 hour Forced Expiratory Volume in 1 second (FEV1) profile of olodaterol (5 and 10 µg) QD (via the Respimat®) in comparison to placebo and to the QD LAMA tiotropium (via the HandiHaler®) over 6 weeks in patients with Global initiative for chronic Obstructive Lung Disease (GOLD) 2-4 COPD.…”

A randomised, placebo-controlled, Phase II, dose-ranging trial of once-daily treatment with olodaterol, a novel long-acting β2-agonist, for 4 weeks in patients with chronic obstructive pulmonary disease

“…However, the fact that olodaterol demonstrates sufficient 24-h bronchodilator efficacy does not necessarily define it as a once-daily treatment. A further Phase II investigation, study 1222.26 (NCT00846768), was conducted to assess the efficacy of both once-and twice-daily dosing regimens [24]; this, Phase II dose-finding study for olodaterol in COPD together with other olodaterol data, led to the development of olodaterol as a once-daily agent. …”