Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease I
Summary
The primary objective of this study is to assess the long-term efficacy and safety of once daily treatment of BI 1744 CL inhalation solution (5 and 10 mcg) delivered via the Respimat® inhaler, in patients with COPD.
Timeline
- Start
- 2009-02
- Primary completion
- 2010-12
- Completion
- —
Outcome
Mixed primary results
registry analysis (superiority or other test); Placebo vs Olo 5 mcg qd; p <0.0001; Mean Difference (Final Values) 0.151 (95% CI 0.110 to 0.193) NCT00793624 ↗
registry analysis (superiority or other test); Placebo vs Olo 5 mcg qd; p = 0.5843; Mean Difference (Final Values) 0.188 (95% CI -0.485 to 0.860) NCT00793624 ↗
registry analysis (superiority or other test); Placebo vs Olo 10 mcg qd; p <0.0001; Mean Difference (Final Values) 0.165 (95% CI 0.124 to 0.206) NCT00793624 ↗
registry analysis (superiority or other test); Placebo vs Olo 10 mcg qd; p = 0.9494; Mean Difference (Final Values) 0.022 (95% CI -0.656 to 0.699) NCT00793624 ↗
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.
- Koch A, Pizzichini E, Hamilton A, Hart L, Korducki L, De Salvo MC, Paggiaro P. Lung function efficacy and symptomatic benefit of olodaterol once daily delivered via Respimat(R) versus placebo and formoterol twice daily in patients with GOLD 2-4 COPD: results from two replicate 48-week studies. Int J Chron Obstruct Pulmon Dis. 2014 Jul 5;9:697-714. doi: 10.2147/COPD.S62502. eCollection 2014.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Formoterol | Other / unclassified | 12 ug | Inhaled |
| Subject | Olodaterol | Small molecule | 5 ug | Inhaled |
| Subject | Olodaterol | Small molecule | 10 ug | Inhaled |