Efficacy and safety of olodaterol once daily delivered via Respimat® in patients with GOLD 2-4 COPD: results from two replicate 48-week studies.

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.

• 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)

Chemical References

• Adrenergic beta-2 Receptor Agonists
• Benzoxazines
• Bronchodilator Agents
• olodaterol

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