Abstract | BACKGROUND:
Olodaterol is a long-acting β2-agonist with a 24-hour bronchodilator profile. Two replicate, randomized, double-blind, placebo-controlled, parallel-group, Phase III trials were performed as part of a comprehensive clinical program to investigate the long-term safety and efficacy of olodaterol in patients with moderate to very severe chronic obstructive pulmonary disease ( COPD) receiving usual-care background therapy. METHODS: Patients received olodaterol 5 μg or 10 μg or placebo once daily for 48 weeks. Coprimary end points were forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 3 hours (AUC0-3) response (change from baseline), and trough FEV1 response at 12 weeks. Secondary end points included additional lung function assessments, use of rescue medications, FEV1 AUC response from 0 to 12 hours, and Patient Global Rating over 48 weeks. RESULTS: Overall, 624 and 642 patients were evaluated in studies 1222.11 and 1222.12, respectively. In both studies, olodaterol 5 μg and 10 μg significantly improved the FEV1 AUC0-3 response (P<0.0001) and trough FEV1 (study 1222.11, P<0.0001; study 1222.12, P<0.05, post hoc) at week 12, with an incidence of adverse events comparable with that of placebo. Secondary end points supported the efficacy of olodaterol. CONCLUSION: These studies demonstrate the long-term efficacy and safety of once-daily olodaterol 5 μg and 10 μg in patients with moderate to very severe COPD continuing with usual-care maintenance therapy.
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Authors | Gary T Ferguson, Gregory J Feldman, Peter Hofbauer, Alan Hamilton, Lisa Allen, Lawrence Korducki, Paul Sachs |
Journal | International journal of chronic obstructive pulmonary disease
(Int J Chron Obstruct Pulmon Dis)
Vol. 9
Pg. 629-45
( 2014)
ISSN: 1178-2005 [Electronic] New Zealand |
PMID | 24966672
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Adrenergic beta-2 Receptor Agonists
- Benzoxazines
- Bronchodilator Agents
- olodaterol
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Topics |
- Administration, Inhalation
- Adrenergic beta-2 Receptor Agonists
(administration & dosage, adverse effects)
- Aged
- Area Under Curve
- Asia
- Australia
- Benzoxazines
(administration & dosage, adverse effects)
- Bronchodilator Agents
(administration & dosage, adverse effects)
- Double-Blind Method
- Equipment Design
- Female
- Forced Expiratory Volume
- Germany
- Humans
- Lung
(drug effects, physiopathology)
- Male
- Middle Aged
- Nebulizers and Vaporizers
- New Zealand
- Predictive Value of Tests
- Pulmonary Disease, Chronic Obstructive
(diagnosis, drug therapy, physiopathology)
- Severity of Illness Index
- Time Factors
- Treatment Outcome
- United States
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