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)

NCT01551888

Phase 2 Completed 24 enrolled AstraZeneca
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

EvaluationDrugModalityDoseRoute
Subject Aclidinium Small molecule 400 ug Inhaled
Comparator Formoterol Other / unclassified 12 ug Inhaled