Study to Assess Efficacy and Safety of Aclidinium Bromide and Aclidinium Bromide/Formoterol Fumarate in Stabile COPD Patients
Summary
This is a multiple dose, randomised, parallel, double blind, double dummy, multicentre and multinational Phase III study to determine the efficacy and safety of Aclidinium bromide/Formoterol fumarate compared with individual components and placebo and Aclidinium bromide compared with Placebo when administered to patients with stable Chronic Obstructive Pulmonary Disease (COPD).
Timeline
- Start
- 2017-02-02
- Primary completion
- 2022-04-14
- Completion
- 2022-04-14
Outcome
Met primary endpoint
registry analysis (superiority test); AB/FF 400/12 μg vs AB 400 μg; p <0.001; Least squares mean difference 0.092 (95% CI 0.060 to 0.124) NCT03022097 ↗
registry analysis (superiority test); AB/FF 400/12 μg vs FF 12 μg; p <0.001; Least squares mean difference 0.085 (95% CI 0.053 to 0.117) NCT03022097 ↗
registry analysis (superiority test); AB 400 μg vs Placebo; p <0.001; Least squares mean difference 0.134 (95% CI 0.103 to 0.166) NCT03022097 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aclidinium | Unknown | 400 ug | Inhaled |
| Subject | Formoterol | Other / unclassified | 12 ug | Inhaled |