Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Combinations of Long-acting β2-agonists (LABA) and Inhaled Glucocorticosteroid (ICS)

PHASE4CompletedINTERVENTIONAL
Enrollment

1,945

Participants

Timeline

Start Date

May 31, 2011

Primary Completion Date

March 31, 2014

Study Completion Date

May 31, 2014

Conditions
Chronic Obstructive Pulmonary Disease
Interventions
DRUG

Roflumilast

500 µg, once daily

DRUG

Placebo

once daily

Trial Locations (180)

1000

Nycomed Investigational Site, Brussels

1035

Nycomed Investigational Site, Witbank Mpumalanga

1125

Nycomed Investigational Site, Budapest

1140

Nycomed Investigational Site, Vienna

1200

Nycomed Investigational Site, Brussels

1500

Nycomed Investigational Site, Benoni Gauteng

2006

Nycomed Investigational Site, Auckland Park, Johannesburg Gauteng

2045

Nycomed Investigational Site, Törökbálint

2057

Nycomed Investigational Site, Morningside, Johannesburg Gauteng

2139

Nycomed Investigational Site, Concord

2193

Nycomed Investigational Site, Johannesburg

2400

Nycomed Investigational Site, København NV

2650

Nycomed Investigational Site, Hvidovre

2660

Nycomed Investigational Site, Balassagyarmat

2700

Nycomed Investigational Site, Cegléd

2900

Nycomed Investigational Site, Hellerup

3050

Nycomed Investigational Site, Parkville

3084

Nycomed Investigational Site, Heidelberg

3128

Nycomed Investigational Site, Box Hill

3168

Nycomed Investigational Site, Clayton

3199

Nycomed Investigational Site, Frankston

3400

Nycomed Investigational Site, Hillerød

3526

Nycomed Investigational Site, Miskolc

3545

Nycomed Investigational Site, Halen

4000

Nycomed Investigational Site, Liège

4092

Nycomed Investigational Site, Durban Kwazulu-Natal

4170

Nycomed Investigational Site, Umkomaas Kwazulu-Natal

4400

Nycomed Investigational Site, Nyíregyháza

4960

Nycomed Investigational Site, Malmedy

5020

Nycomed Investigational Site, Salzburg

5041

Nycomed Investigational site, Daws Park

5065

Nycomed Investigational Site, Toorak Gardens

6772

Nycomed Investigational Site, Deszk

7623

Nycomed Investigational Site, Pécs

7764

Nycomed Investigational Site, Cape Town Western Cape

8036

Nycomed Investigational Site, Graz

8330

Nycomed Investigational Site, Feldbach

8600

Nycomed Investigational Site, Siófok

9300

Nycomed Investigational Site, Csorna

Nycomed Investigational Site, Bloemfontein Free State

9400

Nycomed Investigational Site, Sopron

9700

Nycomed Investigational Site, Szombathely

10367

Nycomed Investigational Site, Berlin

10676

Nycomed Investigational Site, Athens

10969

Nycomed Investigational Site, Berlin

11527

Nycomed Investigational Site, Athens

12203

Nycomed Investigational Site, Berlin

15126

Nycomed Investigational Site, Marousi

15562

Nycomed Investigational Site, Rüdersdorf

16132

Nycomed Investigational Site, Genova

17020

Nycomed Investigational Site, Çanakkale

19002

Nycomed Investigational Site, Guadalajara

20052

Nycomed Investigational Site, Monza

20122

Nycomed Investigational Site, Milan

20138

Nycomed Investigational Site, Milan

22927

Nycomed Investigational Site, Großhansdorf

28007

Nycomed Investigational Site, Madrid

28223

Nycomed Investigational Site, Pozuelo de Alarcón

30167

Nycomed Investigational Site, Hanover

30900

Nycomed Investigational Site, Nîmes

31096

Nycomed Investigational Site, Haifa

33079

Nycomed Investigational Site, Mersin

33170

Nycomed Investigational Site, Pordenone

34098

Nycomed Investigational Site, Istanbul

34362

Nycomed Investigational Site, Haifa

35043

Nycomed Investigational Site, Marburg

35100

Nycomed Investigational Site, Izmir

39008

Nycomed Investigational Site, Santander

41100

Nycomed Investigational Site, Larissa

Nycomed Investigational Site, Modena

41380

Nycomed Investigational Site, Kocaeli

42075

Nycomed Investigational Site, Konya

44011

Nycomed Investigational Site, Ferrara

44281

Nycomed Investigational Site, Kfar Saba

46015

Nycomed Investigational Site, Valencia

49100

Nycomed Investigational Site, Petah Tikva

52621

Nycomed Investigational Site, Tel Litwinsky

56068

Nycomed Investigational Site, Koblenz

57010

Nycomed Investigational Site, Thessaloniki

58100

Nycomed Investigational Site, Holon

64239

Nycomed Investigational Site, Tel Aviv

65201

Nycomed Investigational Site, Kavala

66421

Nycomed Investigational Site, Homburg

67091

Nycomed Investigational Site, Strasbourg

67891

Nycomed Investigational Site, Tel Aviv

68100

Nycomed Investigational Site, Alexandroupoli

71110

Nycomed Investigational Site, Heraklion, Crete

76100

Nycomed Investigational Site, Rehovot

77150

Nycomed Investigational Site, Férolles-Attilly

78278

Nycomed Investigational Site, Ashkelon

84101

Nycomed Investigational Site, Beersheba

86021

Nycomed Investigational Site, Poitiers

90766

Nycomed Investigational Site, Fürth

91031

Nycomed Investigational Site, Jerusalem

91120

Nycomed Investigational Site, Jerusalm

105077

Nycomed Investigational Site, Moscow

117485

Nycomed Investigational Site, Moscow

117574

Nycomed Investigational Site, Moscow

125206

Nycomed Investigational Site, Moscow

150010

Nycomed Investigational Site, Yaroslavl

188640

Nycomed Investigational Site, Vsevolozhsk

196084

Nycomed Investigational Site, Saint Petersburg

197089

Nycomed Investigational Site, Saint Petersburg

197706

Nycomed Investigational Site, Saint Petersburg

214006

Nycomed Investigational Site, Smolensk

400001

Nycomed Investigational Site, Volgograd

410012

Nycomed Investigational Site, Saratov

420029

Nycomed Investigational Site, Kazan'

454021

Nycomed Investigational Site, Chelyabinsk

603011

Nycomed Investigational Site, Nizhny Novgorod

630087

Nycomed Investigational Site, Novosibirsk

630091

Nycomed Investigational Site, Novosibirsk

650002

Nycomed Investigational Site, Kemerovo

Unknown

Nycomed Investigational Site, Belo Horizonte

Nycomed Investigational Site, Botucatu

Nycomed Investigational Site, Florianópolis

Nycomed Investigational Site, Goiânia

Nycomed Investigational Site, Porto Alegre

Nycomed Investigational Site, Rio de Janeiro

Nycomed Investigational Site, São Paulo

Nycomed Investigational Site, Vitória

Nycomed Investigational Site, Érd

Nycomed Investigational Site, Gliwice

Nycomed Investigational Site, Oleśnica

Nycomed Investigational Site, Warsaw

Nycomed Investigational Site, Samara

Nycomed Investigational Site, Daegu

Nycomed Investigational Site, Glasgow

L8N 4A6

Nycomed Investigational Site, Hamilton

K7L 2V7

Nycomed Investigational Site, Kingston

H8S 2E4

Nycomed Investigational Site, Lachine

L2G 1J4

Nycomed Investigational Site, Niagara Falls

L4C 2N9

Nycomed Investigational Site, Richmond Hill

M5T 3A9

Nycomed Investigational Site, Toronto

M6H 3M2

Nycomed Investigational Site, Toronto

R2K 3S8

Nycomed Investigational Site, Winnepeg

06700

Nycomed Investigational Site, Saint-Laurent-du-Var

00133

Nycomed Investigational Site, Roma

5200 ME

Nycomed Investigational Site, 's-Hertogenbosch

3800 BM

Nycomed Investigational Site, Amersfoort

6815 AD

Nycomed Investigational Site, Arnhem

7500 KA

Nycomed Investigational Site, Enschede

6419 PC

Nycomed Investigational Site, Heerlen

1624 NP

Nycomed Investigational Site, Hoorn

15-540

Nycomed Investigational Site, Bialystok

85-681

Nycomed Investigational Site, Bydgoszcz

40-753

Nycomed Investigational Site, Katowice

90-153

Nycomed Investigational Site, Lodz

91-849

Nycomed Investigational Site, Lodz

94-010

Nycomed Investigational Site, Lodz

20-718

Nycomed Investigational Site, Lublin

63-400

Nycomed Investigational Site, Ostrów Wielkopolski

33-100

Nycomed Investigational Site, Tarnów

50-127

Nycomed Investigational Site, Wroclaw

53-301

Nycomed Investigational Site, Wroclaw

47-120

Nycomed Investigational Site, Zawadzkie

975 17

Nycomed Investigational Site, Banská Bystrica

085 01

Nycomed Investigational Site, Bardejov

821 06

Nycomed Investigational Site, Bratislava

826 06

Nycomed Investigational Site, Bratislava

040 01

Nycomed Investigational Site, Košice

036 01

Nycomed Investigational Site, Martin

950 01

Nycomed Investigational Site, Nitra

940 34

Nycomed Investigational Site, Nové Zámky

052 01

Nycomed Investigational Site, Spišská Nová Ves

0380

Nycomed Investigational Site, Thabazimbi Limpopo

431-070

Nycomed Investigational Site, Anyang

361-711

Nycomed Investigational Site, Cheongju-si

110-744

Nycomed Investigational Site, Seoul

120-752

Nycomed Investigational Site, Seoul

152-703

Nycomed Investigational Site, Seoul

220-701

Nycomed Investigational Site, Wŏnju

08022

Nycomed Investigational Site, Barcelona

08221

Nycomed Investigational Site, Terrassa

06590

Nycomed Investigational Site, Ankara

EH16 4TJ

Nycomed Investigational Site, Edinburgh

L9 7AL

Nycomed Investigational Site, Liverpool

E2 9JX

Nycomed Investigational Site, London

NW3 2PF

Nycomed Investigational Site, London

NR4 7UY

Nycomed Investigational Site, Norwich

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY