Effect of Roflumilast on Lung Function in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Salmeterol: The EOS Study (BY217/M2-127)

PHASE3CompletedINTERVENTIONAL
Enrollment

933

Participants

Timeline

Start Date

April 30, 2006

Primary Completion Date

July 31, 2007

Study Completion Date

February 29, 2008

Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Interventions
DRUG

Roflumilast

500 µg, once daily, oral administration in the morning

DRUG

Placebo

once daily

Trial Locations (134)

156

Altana Pharma/Nycomed Investigational Site, Roma

1000

Altana Pharma/Nycomed Investigational Site, Brussels

1030

Altana Pharma/Nycomed Investigational Site, Vienna

1040

Altana Pharma/Nycomed Investigational Site, Brussels

1090

Altana Pharma/Nycomed Investigational Site, Jette

1140

Altana Pharma/Nycomed Investigational Site, Vienna

1150

Altana Pharma/Nycomed Investigational Site, Vienna

2100

Altana Pharma/Nycomed Investigational Site, Saint-Quentin

2303

Altana Pharma/Nycomed Investigational Site, Chauny

2570

Altana Pharma/Nycomed Investigational Site, Duffel

2700

Altana Pharma/Nycomed Investigational Site, Wiener Neustadt

3000

Altana Pharma/Nycomed Investigational Site, Leuven

3100

Altana Pharma/Nycomed Investigational Site, Sankt Pölten

3202

Altana Pharma/Nycomed Investigational Site, Elche (Alicante)

3545

Altana Pharma/Nycomed Investigational Site, Halen

3550

Altana Pharma/Nycomed Investigational Site, Alicante

3600

Altana Pharma/Nycomed Investigational Site, Genk

3610

Altana Pharma/Nycomed Investigational Site, Petrer (Alicante)

3910

Altana Pharma/Nycomed Investigational Site, Zwettl Stadt

4000

Altana Pharma/Nycomed Investigational Site, Liège

4020

Altana Pharma/Nycomed Investigational Site, Linz

4320

Altana Pharma/Nycomed Investigational Site, Perg

4400

Altana Pharma/Nycomed Investigational Site, Steyr

4960

Altana Pharma/Nycomed Investigational Site, Malmedy

5000

Altana Pharma/Nycomed Investigational Site, Namur

5020

Altana Pharma/Nycomed Investigational Site, Salzburg

6000

Altana Pharma/Nycomed Investigational Site, Nice

6002

Altana Pharma/Nycomed Investigational Site, Nice

6060

Altana Pharma/Nycomed Investigational Site, Gilly

6110

Altana Pharma/Nycomed Investigational Site, Montigny-le-Tilleul

6130

Altana Pharma/Nycomed Investigational Site, Grasse

6240

Altana Pharma/Nycomed Investigational Site, Beausoleil

6700

Altana Pharma/Nycomed Investigational Site, Arlon

Altana Pharma/Nycomed Investigational Site, Saint-Laurent-du-Var

7100

Altana Pharma/Nycomed Investigational Site, Neusiedl/See

8017

Altana Pharma/Nycomed Investigational Site, Barcelona

8023

Altana Pharma/Nycomed Investigational Site, Barcelona

8025

Altana Pharma/Nycomed Investigational Site, Barcelona

8208

Altana Pharma/Nycomed Investigational Site, Sabadell

8221

Altana Pharma/Nycomed Investigational Site, Tarrasa (Barcelona)

8222

Altana Pharma/Nycomed Investigational Site, Barcelona

8303

Altana Pharma/Nycomed Investigational Site, Mataró, Barcelona

8630

Altana Pharma/Nycomed Investigational Site, Veurne

10126

Altana Pharma/Nycomed Investigational Site, Torino

12037

Altana Pharma/Nycomed Investigational Site, Saluzzo (CN)

13695

Altana Pharma/Nycomed Investigational Site, Martigues

16100

Altana Pharma/Nycomed Investigational Site, Genova

19002

Altana Pharma/Nycomed Investigational Site, Guadalajara

20153

Altana Pharma/Nycomed Investigational Site, Milan

21049

Altana Pharma/Nycomed Investigational Site, Tradate (VA)

21502

Altana Pharma/Nycomed Investigational Site, Geesthacht

22927

Altana Pharma/Nycomed Investigational Site, Großhansdorf

24411

Altana Pharma/Nycomed Investigational Site, Fuentesnuevas, Ponferrada (León)

26903

Altana Pharma/Nycomed Investigational Site, Surwold

30012

Altana Pharma/Nycomed Investigational Site, Verona

30167

Altana Pharma/Nycomed Investigational Site, Hanover

30900

Altana Pharma/Nycomed Investigational Site, Nîmes

31029

Altana Pharma/Nycomed Investigational Site, Vittorio Veneto (TV)

33170

Altana Pharma/Nycomed Investigational Site, Pordenone

34070

Altana Pharma/Nycomed Investigational Site, Montpellier

35037

Altana Pharma/Nycomed Investigational Site, Marburg

38100

Altana Pharma/Nycomed Investigational Site, Grenoble

39300

Altana Pharma/Nycomed Investigational Site, Torrelavega (Cantabria)

39770

Altana Pharma/Nycomed Investigational Site, Laredo (Cantabria)

44000

Altana Pharma/Nycomed Investigational Site, Nantes

44787

Altana Pharma/Nycomed Investigational Site, Bochum

48138

Altana Pharma/Nycomed Investigational Site, Bologna

49800

Altana Pharma/Nycomed Investigational Site, Trélazé

51069

Altana Pharma/Nycomed Investigational Site, Cologne

53119

Altana Pharma/Nycomed Investigational Site, Bonn

56068

Altana Pharma/Nycomed Investigational Site, Koblenz

56100

Altana Pharma/Nycomed Investigational Site, Cisanello (PI)

57124

Altana Pharma/Nycomed Investigational Site, Livorno

58452

Altana Pharma/Nycomed Investigational Site, Witten

59037

Altana Pharma/Nycomed Investigational Site, Lille

62660

Altana Pharma/Nycomed Investigational Site, Beuvry

63571

Altana Pharma/Nycomed Investigational Site, Gelnhausen

63739

Altana Pharma/Nycomed Investigational Site, Aschaffenburg

66111

Altana Pharma/Nycomed Investigational Site, Saarbrücken

68723

Altana Pharma/Nycomed Investigational Site, Schwetzingen

69003

Altana Pharma/Nycomed Investigational Site, Lyon

70124

Altana Pharma/Nycomed Investigational Site, Bari

74889

Altana Pharma/Nycomed Investigational Site, Sinsheim

95125

Altana Pharma/Nycomed Investigational Site, Catania

97070

Altana Pharma/Nycomed Investigational Site, Würzburg

L1S 2J7

Altana Pharma/Nycomed Investigational Site, Ajax, Ontario

B3H 3A7

Altana Pharma/Nycomed Investigational Site, Halifax, N.S.

L8N4A6

Altana Pharma/Nycomed Investigational Site, Hamilton

L8N3Z5

Altana Pharma/Nycomed Investigational Site, Hamilton, Ontario

H7V3Y7

Altana Pharma/Nycomed Investigational Site, Laval

N6A 5R9

Altana Pharma/Nycomed Investigational Site, London

J7J 2K8

Altana Pharma/Nycomed Investigational Site, Mirabel

H2L 4M1

Altana Pharma/Nycomed Investigational Site, Montreal

H4J 1C5

Altana Pharma/Nycomed Investigational Site, Montreal

H2X2P4

Altana Pharma/Nycomed Investigational Site, Montreal, PQ

L3Y 5G8

Altana Pharma/Nycomed Investigational Site, New Market, on

P1B2H3

Altana Pharma/Nycomed Investigational Site, North Bay

L4C3Y1

Altana Pharma/Nycomed Investigational Site, Ontario

K1Y 4G2

Altana Pharma/Nycomed Investigational Site, Ottawa

G8T 7A1

Altana Pharma/Nycomed Investigational Site, Québec

S4P 1Z7

Altana Pharma/Nycomed Investigational Site, Regina, Saskatchewan

E2K2T8

Altana Pharma/Nycomed Investigational Site, Saint John

G1V4G5

Altana Pharma/Nycomed Investigational Site, Sainte-Foy, Quebec

S7N 0W8

Altana Pharma/Nycomed Investigational Site, Saskatoon SK

J1H 5N4

Altana Pharma/Nycomed Investigational Site, Sherbrooke, PQ

M5B 1W8

Altana Pharma/Nycomed Investigational Site, Toronto, on

M5T 3A9

Altana Pharma/Nycomed Investigational Site, Toronto, on

V6S 3J5

Altana Pharma/Nycomed Investigational Site, Vancouver, BC

N8X 3V6

Altana Pharma/Nycomed Investigational Site, Windsor

R2K 3S8

Altana Pharma/Nycomed Investigational Site, Winnipeg MB

N4S 4G3

Altana Pharma/Nycomed Investigational Site, Woodstock

1815 JD

Altana Pharma/Nycomed Investigational Site, Alkmaar

7609 PP

Altana Pharma/Nycomed Investigational Site, Almelo

5623 EJ

Altana Pharma/Nycomed Investigational Site, Eindhoven

5707 HA

Altana Pharma/Nycomed Investigational Site, Helmond

3116 BA

Altana Pharma/Nycomed Investigational Site, Schiedam

8011 JW

Altana Pharma/Nycomed Investigational Site, Zwolle

Unknown

Altana Pharma/Nycomed Investigational Sites, Cape Town

BT14 6AB

Altana Pharma/Nycomed Investigational Site, Belfast

BT15 2GE

Altana Pharma/Nycomed Investigational Site, Belfast

BT7 1DA

Altana Pharma/Nycomed Investigational Site, Belfast

TN40 1JJ

Altana Pharma/Nycomed Investigational Site, Bexhill-on-Sea, East Sussex

BD157NJ

Altana Pharma/Nycomed Investigational Site, Bradford

BA15 1DQ

Altana Pharma/Nycomed Investigational Site, Bradford on Avon, Wiltshire

S40 4TF

Altana Pharma/Nycomed Investigational Site, Chesterfield Derbyshire

BT52 1HS

Altana Pharma/Nycomed Investigational Site, Coleraine

BT80 8BG

Altana Pharma/Nycomed Investigational Site, Cookstown

TN39 5HE

Altana Pharma/Nycomed Investigational Site, East Sussex

EH8 9AG

Altana Pharma/Nycomed Investigational Site, Edinburgh

G3 8YJ

Altana Pharma/Nycomed Investigational Site, Glasgow

TN34 3EY

Altana Pharma/Nycomed Investigational Site, Hastings

HA6 2RN

Altana Pharma/Nycomed Investigational Site, Middlessex

TW16 6RH

Altana Pharma/Nycomed Investigational Site, Sunbury on Thames, Middlessex

WD25 0EA

Altana Pharma/Nycomed Investigational Site, Watford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY