drugset / Trial / NCT01551888
Pharmacokinetic, Safety and Tolerability Study of Aclidinium/Formoterol Fixed Dose Combination and Formoterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
RandomizedCrossoverTriple-blindTreatment
Summary
The purpose of this Phase II study is to evaluate the pharmacokinetics, safety, and tolerability of aclidinium/formoterol fixed dose combination (FDC 400/12 μg via the Almirall Inhaler and formoterol 12 μg via the Foradil® Aerolizer®, both administered twice daily for five days to patients with moderate to severe COPD.
Timeline
- Start
- 2012-01
- Primary completion
- 2012-03
- Completion
- 2012-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aclidinium | Small molecule | 400 ug | Inhaled |
| Comparator | Formoterol | Other / unclassified | 12 ug | Inhaled |