A randomised, double-blind, four-way, crossover trial comparing the 24-h FEV1 profile for once-daily versus twice-daily treatment with olodaterol, a novel long-acting β2-agonist, in patients with chronic obstructive pulmonary disease. Issue 5 (May 2015)

• Record Type: Journal Article
• Authors: Joos, Guy F.; Aumann, Joseph-Leon; Coeck, Carl; Korducki, Lawrence; Hamilton, Alan L.; Kunz, Christina; Aalbers, René
• Is Part Of: Respiratory medicine. Volume 109:Issue 5(2015)
• Page Start: 606
• Page End: 615
• Publication Date: 2015-05
• Subjects: Chest -- Diseases -- Periodicals; Chest -- Diseases -- Great Britain -- Periodicals; Respiratory organs -- Diseases -- Periodicals; Respiratory Tract Diseases -- Periodicals; Appareil respiratoire -- Maladies -- Périodiques; Thorax -- Maladies -- Périodiques; Appareil respiratoire -- Maladies -- Traitement -- Périodiques; Electronic journals; 616.2
• DOI: 10.1016/j.rmed.2015.02.005
• Languages: English
• ISSNs: 0954-6111

Abstract

<abstract xml:lang="en" abstract-type="author" id="abs0010"> <title id="sectitle0010">Summary</title> <sec> <title id="sectitle0015">Background</title> <p id="abspara0010">This randomised, double-blind, four-way, crossover, Phase II study compared the 24-h forced expiratory volume in 1 s (FEV<sub>1</sub>) profile of alternative dosing frequencies of two total daily doses of olodaterol (5 and 10 μg) in patients with chronic obstructive pulmonary disease (COPD).</p> </sec> <sec> <title id="sectitle0020">Methods</title> <p id="abspara0015">Patients received olodaterol 2 μg twice daily (BID), 5 μg BID, 5 μg once daily (QD) and 10 μg QD in a randomised sequence over 3-week treatment periods. Co-primary end points were FEV<sub>1</sub> area under the curve from 0 to 12 h (AUC<sub>0–12</sub>) and area under the curve from 12 to 24 h (AUC<sub>12–24</sub>) responses. Additional lung-function responses, pharmacokinetics and safety were assessed.</p> </sec> <sec> <title id="sectitle0025">Results</title> <p id="abspara0020">47 patients were treated. All olodaterol doses provided significant increases in FEV<sub>1</sub> versus baseline (<italic>p</italic> < 0.001) and FEV<sub>1</sub> time profiles were nearly identical for olodaterol 5 and 10 μg QD. Olodaterol 5 μg QD demonstrated improved FEV<sub>1</sub> AUC<sub>0–12</sub> and similar AUC<sub>12–24</sub> versus 2 μg BID. Olodaterol 5 μg QD showed slightly increased FEV<sub>1</sub> AUC<sub>0–12</sub> but lower AUC<sub>12–24</sub> compared to 5 μg BID. Bronchodilation over 24 h was similar for olodaterol 5 μg QD and BID. All doses were well tolerated.</p> </sec> <sec> <title id="sectitle0030">Conclusions</title> <p id="abspara0025">Olodaterol 5 μg QD is efficacious in COPD, with a superior bronchodilatory profile compared to 2 μg BID, which is close to the same total daily dose, and a similar degree of bronchodilation over 24 h compared with double the daily dose (administered as 10 μg QD or 5 μg BID).</p> </sec> <sec> <title id="sectitle0035">Trial registration</title> <p id="abspara0030">ClinicalTrials.gov: <ext-link ext-link-type="unknown" id="intref0010" xlink:type="simple" xlink:href="ctgov:NCT00846768" xmlns:xlink="http://www.w3.org/1999/xlink">NCT00846768</ext-link>.</p> </sec> </abstract>