NCT01462929 - Efficacy and Safety of Aclidinium Bromide 400 µg Compared to Placebo and to Tiotropium Bromide in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) | Biotech Hunter

Enrollment

414

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

March 31, 2012

Study Completion Date

May 31, 2012

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

Aclidinium bromide

Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)

DRUG

Tiotropium

Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)

DRUG

Placebo

Dosage form: Dry powder Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h).

Trial Locations (41)

2310

Almirall Investigational Site #11, Szigetszentmiklós

2900

Almirall Investigational Site #2, Komárom

3233

Almirall Investigational Site #3, Mátraháza

4043

Almirall Investigational Site #4, Debrecen

5540

Almirall Investigational Site #1, Szarvas

10117

Almirall Investigational Site #4, Berlin

10717

Almirall Investigational Site #12, Berlin

10969

Almirall Investigational Site #10, Berlin

13125

Almirall Investigational Site #8, Berlin

13507

Almirall Investigational Site #20, Berlin

14050

Almirall Investigational Site #21, Berlin

14057

Almirall Investigational Site #2, Berlin

15562

Almirall Investigational Site #23, Rudersdorf

19055

Almirall Investigational Site #6, Schwerin

20253

Almirall Investigational Site #1, Hamburg

22143

Almirall Investigational Site #18, Hamburg

22927

Almirall Investigational Site #3, Großhansdorf

23552

Almirall Investigational Site #17, Lübeck

30159

Almirall Investigational Site #5, Hanover

30625

Almirall Investigational Site #22, Hanover

51069

Almirall Investigational Site #24, Cologne

60596

Almirall Investigational Site #9, Frankfurt

65187

Almirall Investigational Site #16, Wiesbaden

396 26

Almirall Investigational Site #9, Humpolec

551 01

Almirall Investigational Site #1, Jaroměř

276 01

Almirall Investigational Site #3, Mělník

Unknown

Almirall Investigational Site #13, Dresden

07740

Almirall Investigational Site #14, Jena

15-540

Almirall Investigational Site #18, Bialystok

Almirall Investigational Site #8, Bialystok

82-300

Almirall Investigational Site #2, Elblag

31-023

Almirall Investigational Site #17, Krakow

31-455

Almirall Investigational Site #10, Krakow

90-153

Almirall Investigational Site #16, Lodz

Almirall Investigational Site #20, Lodz

32-100

Almirall Investigational Site #4, Proszowice

84-741

Almirall Investigational Site #6, Sopot

33-100

Almirall Investigational Site #14, Tarnów

01-138

Almirall Investigational Site #19, Warsaw

43-365

Almirall Investigational Site #12, Wilkowice-Bystra

50-349

Almirall Investigational Site #13, Wroclaw