Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator in Chronic Obstructive Pulmonary Disease (COPD) Patients.

PHASE2CompletedINTERVENTIONAL
Enrollment

79

Participants

Timeline

Start Date

May 31, 2010

Primary Completion Date

August 31, 2010

Study Completion Date

August 31, 2010

Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Interventions
DRUG

Aclidinium bromide 100 μg bid

Aclidinium bromide 100 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days

DRUG

Aclidinium bromide 200 μg bid

Aclidinium bromide 200 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days

DRUG

Aclidininum bromide 400 μg bid

Aclidinium bromide 400 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days

DRUG

Placebo

Placebo via inhalation in the morning and evening for 7 days

DRUG

Formoterol 12 μg bid

Formoterol 12 μg twice-daily via inhalation by Aerolizer® dry powder inhaler: 1 puff in the morning and evening for 7 days

Trial Locations (11)

10117

Almirall Investigational Sites#3, Berlin

13125

Almirall Investigational Sites#4, Berlin

14050

Almirall Investigational Sites#9, Berlin

19055

Almirall Investigational Sites#6, Schwerin

20249

Almirall Investigational Sites#5, Hamburg

22927

Almirall Investigational Sites#1, Groβhansdorf

30159

Almirall Investigational Sites#7, Hanover

30625

Almirall Investigational Sites#2, Hanover

60596

Almirall Investigational Sites#8, Frankfurt

65187

Almirall Investigational Sites#10, Wiesbaden

B-9000

Almirall Investigational Sites#1, Ghent

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY