12 / 48 wk Pivotal PFT vs PBO in COPD II
Summary
This primary objective of this study is to compare two doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily to placebo in patients with chronic obstructive pulmonary disease (COPD).
Timeline
- Start
- 2009-02
- Primary completion
- 2010-09
- Completion
- —
Outcome
Met primary endpoint
registry Placebo vs Olo 5 mcg qd; p <0.0001; Mean Difference (Final Values) 0.151 (95% CI 0.116 to 0.185); Mixed Models Analysis NCT00782509 ↗
registry Placebo vs Olo 10 mcg qd; p <0.0001; Mean Difference (Final Values) 0.143 (95% CI 0.110 to 0.177); Mixed Models Analysis NCT00782509 ↗
registry Placebo vs Olo 5 mcg qd; p = 0.0116; Mean Difference (Final Values) 0.047 (95% CI 0.011 to 0.084); Mixed Models Analysis NCT00782509 ↗
registry Placebo vs Olo 10 mcg qd; p = 0.0095; Mean Difference (Final Values) 0.048 (95% CI 0.012 to 0.085); Mixed Models Analysis NCT00782509 ↗
Publications
- Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1.
- Andreas S, Bothner U, de la Hoz A, Kloer I, Trampisch M, Alter P. A Post Hoc Holter ECG Analysis of Olodaterol and Formoterol in Moderate-to-Very-Severe COPD. Int J Chron Obstruct Pulmon Dis. 2020 Aug 10;15:1955-1965. doi: 10.2147/COPD.S246353. eCollection 2020.
- Andreas S, Bothner U, Trampisch M, Haensel M, Buhl R, Alter P. Effect of long-acting beta2-agonists olodaterol and formoterol on heart rate and blood pressure in chronic obstructive pulmonary disease patients. Pulm Pharmacol Ther. 2018 Oct;52:1-6. doi: 10.1016/j.pupt.2018.08.002. Epub 2018 Aug 2.
- Ferguson GT, Feldman GJ, Hofbauer P, Hamilton A, Allen L, Korducki L, Sachs P. Efficacy and safety of olodaterol once daily delivered via Respimat(R) in patients with GOLD 2-4 COPD: results from two replicate 48-week studies. Int J Chron Obstruct Pulmon Dis. 2014 Jun 16;9:629-45. doi: 10.2147/COPD.S61717. eCollection 2014.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olodaterol | Small molecule | 5 ug | Inhaled |
| Subject | Olodaterol | Small molecule | 10 ug | Inhaled |