Pharmacokinetics, Safety and Tolerability of Twice-Daily Aclidinium Bromide/Formoterol Fumarate Fixed Dose Combination in Chinese Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Study identifier:D6572C00001

ClinicalTrials.gov identifier:NCT03276078

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase IIa, Open-Label, Repeat-Dose Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Fixed Dose Combination Administered Twice-Daily by Inhalation in Chinese Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Medical condition

Pulmonary Disease, Chronic Obstructive

Phase

Phase 2

Healthy volunteers

No

Study drug

Aclidinium Bromide/Formoterol Fumarate 400/12μg BID

Sex

All

Actual Enrollment

20

Study type

Interventional

Age

40 Years - 130 Years

Date

Study Start Date: 23 Nov 2017
Primary Completion Date: 12 Jun 2018
Study Completion Date: 12 Jun 2018

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 May 2019 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria