Long-term Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-Dose Combination

PHASE3CompletedINTERVENTIONAL
Enrollment

2,443

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

January 31, 2013

Study Completion Date

January 31, 2013

Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Interventions
DRUG

Aclidinium Bromide/Formoterol Fumarate

Inhaled Aclidinium/formoterol Fixed Dose Combination (FDC) low dose (400/6 μg), twice per day

DRUG

Aclidinium Bromide/Formoterol Fumarate

Inhaled Aclidinium/formoterol FDC high dose (400/12 μg), twice per day

DRUG

Aclidinium Bromide

Inhaled Aclidinium 400 μg, twice per day

DRUG

Placebo

Inhaled dose-matched placebo, twice per day

DRUG

Formoterol Fumarate

Inhaled Formoterol 12 μg, twice per day

Trial Locations (197)

2

Almirall Investigational Site #12, Pretoria

Almirall Investigational Site #13, Pretoria

84

Almirall Investigational Site #3, Pretoria

1000

Almirall Investigational Site #8, Sofia

1033

Almirall Investigational Site #16, Budapest

1036

Almirall Investigational Site #12, Budapest

Almirall Investigational Site #17, Budapest

1067

Almirall Investigational Site #15, Dresden

Almirall Investigational Site #35, Sachsen

1125

Almirall Investigational Site #6, Budapest

1221

Almirall Investigational Site #14, Budapest

1307

Almirall Investigational Site #10, Dresden

1431

Almirall Investigational Site #2, Sofia

1529

Almirall Investigational Site #5, Budapest

1709

Almirall Investigational Site #11, Sofia

1724

Almirall Investigational Site #8, Roodepoort

2045

Almirall Investigational Site #7, Törökbálint

2400

Almirall Investigational Site #1, København NV

2650

Almirall Investigational Site #3, Edegem

2660

Almirall Investigational Site #4, Balassagyarmat

2740

Almirall Investigational Site #7, Espoo

2826

Almirall Investigational Site #27, Sachsen

2900

Almirall Investigational Site #9, Komárom

3400

Almirall Investigational Site #4, Hillerød

3534

Almirall Investigational Site #2, Miskolc

3600

Almirall Investigational Site #2, Genk

3680

Almirall Investigational Site #2, Kyiv

Almirall Investigational Site #3, Kyiv

Almirall Investigational Site #4, Kyiv

4050

Almirall Investigational Site #5, Kyiv

4103

Almirall Investigational Site #25, Sachsen

4126

Almirall Investigational Site #1, eManzimtoti

4400

Almirall Investigational Site #3, Nyíregyháza

5000

Almirall Investigational Site #5, Odense

5020

Almirall Investigational Site #3, Salzburg

5201

Almirall Investigational Site #4, Spišská Nová Ves

5400

Almirall Investigational Site #10, Sevlievo

6772

Almirall Investigational Site #1, Deszk

7002

Almirall Investigational Site #6, Rousse

7129

Almirall Investigational Site #5, Somerset West

7500

Almirall Investigational Site #16, Cape Town

Almirall Investigational Site #2, Cape Town

7700

Almirall Investigational Site #15, Cape Town, Western Cape

8003

Almirall Investigational Site #7, Barcelona

8036

Almirall Investigational Site #2, Graz

8360

Almirall Investigational Site #3, Canet de Mar

8501

Almirall Investigational Site #5, Bardejov

8600

Almirall Investigational Site #2, Silkeborg

8800

Almirall Investigational Site #13, Nagykanizsa

8900

Almirall Investigational Site #11, Zalaegerszeg

8916

Almirall Investigational Site #12, Barcelona

9200

Almirall Investigational Site #15, Mosonmagyaróvár

10000

Almirall Investigational Site #2, Zagreb

Almirall Investigational Site #4, Zagreb

10003

Almirall Investigational Site #10, Cáceres

10117

Almirall Investigational Site #2, Berlin

10629

Almirall Investigational Site #12, Berlin

12627

Almirall Investigational Site #19, Berlin

13125

Almirall Investigational Site #11, Berlin

13291

Almirall Investigational Site #10, Marseille

14059

Almirall Investigational Site #24, Berlin

16132

Almirall Investigational Site #15, Genova

16268

Almirall Investigational Site #4, Vällingby

18200

Almirall Investigational Site #14, Prague

19055

Almirall Investigational Site #8, Schwerin

20253

Almirall Investigational Site #7, Hamburg

20520

Almirall Investigational Site #3, Turku

21029

Almirall Investigational Site #10, Vinnytsia

21152

Almirall Investigational Site #3, Malmo

21382

Almirall Investigational Site #9, Bucharest

21659

Almirall Investigational Site #18, Bucharest

22143

Almirall Investigational Site #21, Hamburg

22185

Almirall Investigational Site #1, Lund

22222

Almirall Investigational Site #6, Lund

23538

Almirall Investigational Site #1, Lübeck

23858

Almirall Investigational Site #22, Reinfeld

29010

Almirall Investigational Site #1, Málaga

30159

Almirall Investigational Site #32, Land Niedersachsen

30303

Almirall Investigational Site #7, Bucharest

31059

Almirall Investigational Site #8, Toulouse

33006

Almirall Investigational Site #9, Oviedo

33520

Almirall Investigational Site #1, Tampere

Almirall Investigational Site #6, Tampere

33604

Almirall Investigational Site #1, Pessac

34295

Almirall Investigational Site #11, Montpellier

35033

Almirall Investigational Site #3, Rennes

35037

Almirall Investigational Site #20, Marburg

39104

Almirall Investigational Site #28, Sachsen

40100

Almirall Investigational Site #8, Jyväskylä

41071

Almirall Investigational Site #8, Seville

41263

Almirall Investigational Site #2, Gothenburg

43100

Almirall Investigational Site #3, Parma

44263

Almirall Investigational Site #33, Haltern am See

44787

Almirall Investigational Site #16, Bochum

49051

Almirall Investigational Site #12, Dnipropetrovsk

50554

Almirall Investigational Site #10, Bucharest

53100

Almirall Investigational Site #1, Siena

53123

Almirall Investigational Site #23, Bonn

54003

Almirall Investigational Site #8, Mykolaiv

55131

Almirall Investigational Site #6, Mainz

56124

Almirall Investigational Site #5, Pisa

58452

Almirall Investigational Site #4, Witten

59037

Almirall Investigational Site #6, Lille

59690

Almirall Investigational Site #12, Vieux-Condé

60389

Almirall Investigational Site #5, Frankfurt

60596

Almirall Investigational Site #13, Frankfurt

Almirall Investigational Site #36, Hessen

61035

Almirall Investigational Site #1, Kharkiv

61039

Almirall Investigational Site #17, Kharkiv

65691

Almirall Investigational Site #8, Brno

76012

Almirall Investigational Site #11, Ivano-Frankivsk

80539

Almirall Investigational Site #34, München

83099

Almirall Investigational Site #9, Donetsk

90402

Almirall Investigational Site #18, Nuremberg

91045

Almirall Investigational Site #6, Luhansk

98603

Almirall Investigational Site #18, Crimea Oblast

109240

Almirall Investigational Site #2, Moscow

119620

Almirall Investigational Site #1, Moscow

194044

Almirall Investigational Site #7, Saint Petersburg

194354

Almirall Investigational Site #12, Saint Petersburg

200515

Almirall Investigational Site #3, Craiova

330084

Almirall Investigational Site #8, Deva

500075

Almirall Investigational Site #1, Brasov

630089

Almirall Investigational Site #9, Novosibirsk

700115

Almirall Investigational Site #6, Iași

700381

Almirall Investigational Site #16, Iași

900002

Almirall Investigational Site #17, Constanța

Almirall Investigational Site #2, Constanța

377 01

Almirall Investigational Site #3, Jindřichův Hradec

360 00

Almirall Investigational Site #10, Karlovy Vary

460 63

Almirall Investigational Site #9, Liberec

700 30

Almirall Investigational Site #16, Ostrava Hrabuvka

130 00

Almirall Investigational Site #2, Prague

155 00

Almirall Investigational Site #12, Prague

163 00

Almirall Investigational Site #15, Prague

153 00

Almirall Investigational Site #6, Praha 5 - Radotin

386 01

Almirall Investigational Site #11, Strakonice

390 01

Almirall Investigational Site #1, Tábor

6191 JW

Almirall Investigational Site #8, Beek

4811 VL

Almirall Investigational Site #7, Breda

5632 EJ

Almirall Investigational Site #13, Eindhoven

2352 RA

Almirall Investigational Site #1, Leiderdorp

3021 HC

Almirall Investigational Site #9, Rotterdam

6883 ES

Almirall Investigational Site #11, Velp

2724 EK

Almirall Investigational Site #10, Zoetermeer

15-003

Almirall Investigational Site #26, Bialystok

15-540

Almirall Investigational Site #3, Bialystok

43-316

Almirall Investigational Site #19, Bielsko-Biala

85-079

Almirall Investigational Site #23, Bydgoszcz

81-384

Almirall Investigational Site #21, Gdynia

40-748

Almirall Investigational Site #5, Katowice

40-751

Almirall Investigational Site #22, Katowice

31-024

Almirall Investigational Site #7, Krakow

31-159

Almirall Investigational Site #9, Krakow

92-216

Almirall Investigational Site #6, Lodz

93-319

Almirall Investigational Site #1, Lodz

20-718

Almirall Investigational Site #14, Lublin

55-200

Almirall Investigational Site #8, Oława

60-214

Almirall Investigational Site #2, Poznan

60-693

Almirall Investigational Site #11, Poznan

60-823

Almirall Investigational Site #4, Poznan

87-100

Almirall Investigational Site #13, Torun

Almirall Investigational Site #18, Torun

01-138

Almirall Investigational Site #10, Warsaw

Almirall Investigational Site #15, Warsaw

01-868

Almirall Investigational Site #16, Warsaw

RO540136

Almirall Investigational Site #5, Târgu Mureş

975 17

Almirall Investigational Site #6, Banská Bystrica

821 06

Almirall Investigational Site #3, Bratislava

940 01

Almirall Investigational Site #1, Nové Zámky

943 01

Almirall Investigational Site #9, Štúrovo

059 84

Almirall Investigational Site #10, Vyšné Hágy

420-767

Almirall Investigational Site #7, Buchon-si

431-070

Almirall Investigational Site #4, Gyeonggi-do

110-744

Almirall Investigational Site #8, Seoul

120-752

Almirall Investigational Site #6, Seoul

136-705

Almirall Investigational Site #3, Seoul

137-710

Almirall Investigational Site #5, Seoul

152-703

Almirall Investigational Site #2, Seoul

158-710

Almirall Investigational Site #1, Seoul

03680

Almirall Investigational Site #15, Kyiv

B15 2SQ

Almirall Investigational Site #6, Birmingham

BD9 6RJ

Almirall Investigational Site #12, Bradford

CB2 2QQ

Almirall Investigational Site #10, Cambridge

CF14 5GJ

Almirall Investigational Site #13, Cardiff

PR7 7NA

Almirall Investigational Site #5, Chorley

G81 2DR

Almirall Investigational Site #2, Glasgow

HU16 5JQ

Almirall Investigational Site #11, Hull

L22 0LG

Almirall Investigational Site #14, Liverpool

E2 9JX

Almirall Investigational Site #1, London

M15 6SX

Almirall Investigational Site #4, Manchester

M23 9QZ

Almirall Investigational Site #8, Manchester

CH49 5PE

Almirall Investigational Site #17, Metropolitan Borough of Wirral

NE7 7DN

Almirall Investigational Site #18, Newcastle upon Tyne

RG2 7AG

Almirall Investigational Site #7, Reading

TS19 8PE

Almirall Investigational Site #16, Stockton-on-Tees

WV10 0QP

Almirall Investigational Site #15, West Midlands

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY

NCT01462942 - Long-term Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-Dose Combination | Biotech Hunter | Biotech Hunter