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
| Autor: | Lawrence Korducki, Christina Kunz, R. Aalbers, Carl Coeck, Guy Joos, Joseph-Leon Aumann, Alan Hamilton |
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| Rok vydání: | 2015 |
| Předmět: |
Male
Pulmonary and Respiratory Medicine Vital capacity Vital Capacity FEV1/FVC ratio chemistry.chemical_compound Pulmonary Disease Chronic Obstructive Pharmacokinetics Double-Blind Method Forced Expiratory Volume Administration Inhalation Medicine COPD Humans Adrenergic beta-2 Receptor Agonists Asthma Aged Long-acting beta-2-agonist Cross-Over Studies Dose-Response Relationship Drug business.industry Olodaterol Area under the curve Middle Aged medicine.disease Crossover study Benzoxazines Bronchodilator Agents chemistry Anesthesia Female business |
| Zdroj: | Respiratory Medicine. 109(5):606-615 |
| ISSN: | 0954-6111 |
| DOI: | 10.1016/j.rmed.2015.02.005 |
| Popis: | Summary Background This randomised, double-blind, four-way, crossover, Phase II study compared the 24-h forced expiratory volume in 1 s (FEV 1 ) profile of alternative dosing frequencies of two total daily doses of olodaterol (5 and 10 μg) in patients with chronic obstructive pulmonary disease (COPD). Methods 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 1 area under the curve from 0 to 12 h (AUC 0–12 ) and area under the curve from 12 to 24 h (AUC 12–24 ) responses. Additional lung-function responses, pharmacokinetics and safety were assessed. Results 47 patients were treated. All olodaterol doses provided significant increases in FEV 1 versus baseline ( p 1 time profiles were nearly identical for olodaterol 5 and 10 μg QD. Olodaterol 5 μg QD demonstrated improved FEV 1 AUC 0–12 and similar AUC 12–24 versus 2 μg BID. Olodaterol 5 μg QD showed slightly increased FEV 1 AUC 0–12 but lower AUC 12–24 compared to 5 μg BID. Bronchodilation over 24 h was similar for olodaterol 5 μg QD and BID. All doses were well tolerated. Conclusions 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). Trial registration ClinicalTrials.gov: NCT00846768. |
| Databáze: | OpenAIRE |
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