Pharmacokinetic, Safety and Tolerability Study of Aclidinium/Formoterol Fixed Dose Combination and Formoterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Study identifier:LAC-PK-01

ClinicalTrials.gov identifier:NCT01551888

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 2a, Randomized, Open-Label, 2-Way Crossover Study To Determine The Pharmacokinetics, Safety, And Tolerability Of Aclidinium/Formoterol 400/12 µg Fixed Dose Combination Via Almirall Inhaler And Formoterol 12 µg Via Foradil® Aerolizer® In Patients With Moderate To Severe Chronic Obstructive Pulmonary Disease

Medical condition

Chronic obstructive pulmonary disease (COPD)

Phase

Phase 2

Healthy volunteers

No

Study drug

Aclidinium/formoterol 400/12μg, Formoterol

Sex

All

Actual Enrollment

24

Study type

Interventional

Age

40 Years +

Date

Study Start Date: 01 Jan 2012
Primary Completion Date: 01 Mar 2012
Study Completion Date: 01 Mar 2012

Study design

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2016 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria