Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

828

Participants

Timeline

Start Date

October 31, 2009

Primary Completion Date

November 30, 2010

Study Completion Date

November 30, 2010

Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Interventions
DRUG

Aclidinium bromide 200 μg bid

Aclidinium bromide 200 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks

DRUG

Aclidinium bromide 400 μg bid

Aclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks

DRUG

Placebo

Placebo twice-daily by inhalation for 24 weeks

Trial Locations (106)

181

Almirall Investigational Sites#6, Pretoria

1036

Almirall Investigational Sites#13, Budapest

1046

Almirall Investigational Sites#4, Budapest

1125

Almirall Investigational Sites#1, Budapest

1529

Almirall Investigational Sites#2, Budapest

2300

Almirall Investigational Sites#11, Ráckeve

2400

Almirall Investigational Sites#10, Dunaüjváros

2440

Almirall Investigational Sites#3, Százhalombatta

3233

Almirall Investigational Sites#9, Mátraháza

4032

Almirall Investigational Sites#6, Debrecen

4043

Almirall Investigational Sites#5, Debrecen

6045

Almirall Investigational Sites#4, Port Elizabeth

6529

Almirall Investigational Sites#9, George

6772

Almirall Investigational Sites#7, Deszk

7500

Almirall Investigational Sites#10, Cape Town

7505

Almirall Investigational Sites#1, Cape Town

7621

Almirall Investigational Sites#12, Pécs

8900

Almirall Investigational Sites#8, Zalaegerszeg

9300

Almirall Investigational Sites#8, Bloemfontein

9301

Almirall Investigational Sites#11, Bloemfontein

Almirall Investigational Sites#3, Bloemfontein

10117

Almirall Investigational Sites#8, Berlin

10969

Almirall Investigational Sites#9, Berlin

13008

Almirall Investigational Sites#2, Marseille

13125

Almirall Investigational Sites#6, Berlin

13507

Almirall Investigational Sites#14, Berlin

13915

Almirall Investigational Sites#1, Marseille

14057

Almirall Investigational Site#7, Berlin

15562

Almirall Investigational Site#2, Rüdersdorf

16132

Almirall Investigational Sites#1, Genova

20249

Almirall Investigational Sites#5, Hamburg

22143

Almirall Investigational Sites#4, Hamburg

22927

Almirall Investigational Sites#1, Großhansdorf

28041

Almirall Investigational Sites#3, Madrid

30159

Almirall Investigational Site#16, Hanover

31059

Almirall Investigational Sites#4, Toulouse

34295

Almirall Investigational Sites#6, Montpellier

44263

Almirall Investigational Sites#3, Dortmund

45879

Almirall Investigational Sites#15, Gelsenkirchen

46015

Almirall Investigational Sites#5, Valencia

51069

Almirall Investigational Sites#10, Cologne

53123

Almirall Investigational Sites#12, Bonn

55131

Almirall Investigational Sites#11, Mainz

56124

Almirall Investigational Sites#10, Pisa

60596

Almirall Investigational Sites#13, Frankfurt

61001

Almirall Investigational Sites#3, Kharkiv

63003

Almirall Investigational Sites#3, Clermont-Ferrand

69118

Almirall Investigational Sites#5, Zaporizhzhya

83099

Almirall Investigational Sites#4, Donetsk

115446

Almirall Investigational Sites#2, Moscow

123182

Almirall Investigational Sites#14, Moscow

194354

Almirall Investigational Sites#10, Saint Petersburg

197022

Almirall Investigational Sites#3, Saint Petersburg

630008

Almirall Investigational Sites#13, Novosibirsk

634050

Almirall Investigational Sites#12, Tomsk

256 01

Almirall Investigational Sites#4, Benešov

55 101

Almirall Investigational Sites#9, Jaroměř

460 01

Almirall Investigational Sites#3, Liberec

410 02

Almirall Investigational Sites#2, Lovosice

277 11

Almirall Investigational Sites#1, Neratovice

158 00

Almirall Investigational Sites#11, Prague

Almirall Investigational Sites#6, Prague

163 00

Almirall Investigational Sites#12, Prague

169 00

Almirall Investigational Sites#7, Prague

386 01

Almirall Investigational Sites#10, Strakonice

07743

Almirall Investigational Sites#18, Jena

09126

Almirall Investigational Sites#3, Cagliari

Unknown

Almirall Investigational Sites#8, Cusco

Almirall Investigational Sites#8, Lublin

Almirall Investigational Sites#12, Cape Town

Almirall Investigational Sites#15, Cape Town

Almirall Investigational Sites#2, Durban

15-003

Almirall Investigational Sites#12, Bialystok

15-540

Almirall Investigational Sites#9, Bialystok

82-307

Almirall Investigational Sites#19, Elblag

80-211

Almirall Investigational Sites#18, Gdansk

14-200

Almirall Investigational Sites#20, Iława

90-430

Almirall Investigational Sites#7, Lodz

91-153

Almirall Investigational Sites#1, Lodz

10-357

Almirall Investigational Sites#24, Olsztyn

Almirall Investigational Sites#5, Olsztyn

60-214

Almirall Investigational Sites#21, Poznan

60-693

Almirall Investigational Sites#16, Poznan

32-100

Almirall Investigational Site#11, Proszowice

41-709

Almirall Investigational Sites#2, Ruda Śląska

05-320

Almirall Investigational Sites#13, Rudka

81-741

Almirall Investigational Sites#4, Sopot

70-111

Almirall Investigational Sites#14, Szczecin

33-100

Almirall Investigational Sites#15, Tarnów

Almirall Investigational Sites#6, Tarnów

01-138

Almirall Investigational Sites#25, Warsaw

43-365

Almirall Investigational Sites#23, Wilkowice-Bystra

50-349

Almirall Investigational Site#10, Wroclaw

420015/420103

Almirall Investigational Sites#5, Kazan'

127018/127473

Almirall Investigational Sites#6, Moscow

197089/197022

Almirall Investigational Sites#4, Saint Petersburg

634050/634034

Almirall Investigational Sites#8, Tomsk

620219 / 620109

Almirall Investigational Sites#7, Yekaterinburg

0002

Almirall Investigational Sites#5, Pretoria

0081

Almirall Investigational Sites#14, Pretoria

08916

Almirall Investigational Sites#6, Badalona

08035

Almirall Investigational Sites#8, Barcelona

08036

Almirall Investigational Sites#7, Barcelona

03680

Almirall Investigational Sites#1, Kyiv

Almirall Investigational Sites#2, Kyiv

04050

Almirall Investigational Sites#7, Kyiv

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