Effect of Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Tiotropium: The HELIOS Study (BY217/M2-128)

PHASE3CompletedINTERVENTIONAL
Enrollment

743

Participants

Timeline

Start Date

January 31, 2007

Primary Completion Date

January 31, 2008

Study Completion Date

July 31, 2008

Conditions
Chronic Obstructive Pulmonary Disease
Interventions
DRUG

Roflumilast

500 µg, once daily, oral administration in the morning

DRUG

Placebo

once daily

Trial Locations (103)

1046

Altana Pharma/Nycomed Investigational Site, Budapest

1134

Altana Pharma/Nycomed Investigational Site, Budapest

1529

Altana Pharma/Nycomed Investigational Site, Budapest

2030

Altana Pharma/Nycomed Investigational Site, Érd

2100

Altana Pharma/Nycomed Investigational Site, Saint-Quentin

2230

Altana Pharma/Nycomed Investigational Site, Gänserndorf

2303

Altana Pharma/Nycomed Investigational Site, Chauny

2700

Altana Pharma/Nycomed Investigational Site, Cegléd

3010

Altana Pharma/Nycomed Investigational Site, Alicante

3233

Altana Pharma/Nycomed Investigational Site, Mátraháza

4040

Altana Pharma/Nycomed Investigational Site, Linz

4412

Altana Pharma/Nycomed Investigational Site, Nyiregyháza

5006

Altana Pharma/Nycomed Investigational Site, Szolnok

5400

Altana Pharma/Nycomed Investigational Site, Hallein

6000

Altana Pharma/Nycomed Investigational Site, Nice

6130

Altana Pharma/Nycomed Investigational Site, Grasse

6600

Altana Pharma/Nycomed Investigational Site, Szentes

6700

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

6800

Altana Pharma/Nycomed Investigational Site, Hódmezovásárhely

8190

Altana Pharma/Nycomed Investigational Site, Sant Cugat del Vallès

8330

Altana Pharma/Nycomed Investigational Site, Feldbach

9024

Altana Pharma/Nycomed Investigational Site, Győr

9300

Altana Pharma/Nycomed Investigational Site, Csorna

9800

Altana Pharma/Nycomed Investigational Site, Spittal an der Drau

11407

Altana Pharma/Nycomed Investigational Site, Jerez de la Frontera

13695

Altana Pharma/Nycomed Investigational Site, Martigues

15006

Altana Pharma/Nycomed Investigational Site, A Coruña

16132

Altana Pharma/Nycomed Investigational Site, Genova

19002

Altana Pharma/Nycomed Investigational Site, Guadalajara

20153

Altana Pharma/Nycomed Investigational Site, Milan

21502

Altana Pharma/Nycomed Investigational Site, Geesthacht

25198

Altana Pharma/Nycomed Investigational Site, Lleida

27004

Altana Pharma/Nycomed Investigational Site, Lugo

28007

Altana Pharma/Nycomed Investigational Site, Madrid

28034

Altana Pharma/Nycomed Investigational Site, Madrid

28047

Altana Pharma/Nycomed Investigational Site, Madrid

28223

Altana Pharma/Nycomed Investigational Site, Pozuelo de Alarcón

28844

Altana Pharma/Nycomed Investigational Site, Weyhe

28935

Altana Pharma/Nycomed Investigational Site, Candia

Altana Pharma/Nycomed Investigational Site, Mostoles Madrid

30012

Altana Pharma/Nycomed Investigational Site, Verona

30029

Altana Pharma/Nycomed Investigational Site, Nîmes

30167

Altana Pharma/Nycomed Investigational Site, Hanover

30900

Altana Pharma/Nycomed Investigational Site, Nîmes

33170

Altana Pharma/Nycomed Investigational Site, Pordenone

35037

Altana Pharma/Nycomed Investigational Site, Marburg

36061

Altana Pharma/Nycomed Investigational Site, Bassano Del Grappa (VI)

38010

Altana Pharma/Nycomed Investigational Site, Santa Cruz de Tenerife

41013

Altana Pharma/Nycomed Investigational Site, Seville

41020

Altana Pharma/Nycomed Investigational Site, Pavullo Nel Frignano (MO)

41100

Altana Pharma/Nycomed Investigational Site, Modena

42100

Altana Pharma/Nycomed Investigational Site, Reggio Emilia

44000

Altana Pharma/Nycomed Investigational Site, Nantes

44263

Altana Pharma/Nycomed Investigational Site, Dortmund

46010

Altana Pharma/Nycomed Investigational Site, Valencia

46014

Altana Pharma/Nycomed Investigational Site, Valencia

46015

Altana Pharma/Nycomed Investigational Site, Valencia

46017

Altana Pharma/Nycomed Investigational Site, Valencia

46340

Altana Pharma/Nycomed Investigational Site, Requena

48903

Altana Pharma/Nycomed Investigational Site, Baracaldo (Vizcaya)

48960

Altana Pharma/Nycomed Investigational Site, Galdakao

56068

Altana Pharma/Nycomed Investigational Site, Koblenz

56100

Altana Pharma/Nycomed Investigational Site, Cisanello (PI)

57950

Altana Pharma/Nycomed Investigational Site, Montigny-lès-Metz

58452

Altana Pharma/Nycomed Investigational Site, Witten

61348

Altana Pharma/Nycomed Investigational Site, Bad Homburg

62660

Altana Pharma/Nycomed Investigational Site, Beuvry

63571

Altana Pharma/Nycomed Investigational Site, Gelnhausen

66046

Altana Pharma/Nycomed Investigational Site, Perpignan

66111

Altana Pharma/Nycomed Investigational Site, Saarbrücken

66740

Altana Pharma/Nycomed Investigational Site, Saarlouis

68723

Altana Pharma/Nycomed Investigational Site, Schwetzingen

69003

Altana Pharma/Nycomed Investigational Site, Lyon

71100

Altana Pharma/Nycomed Investigational Site, Foggia

71229

Altana Pharma/Nycomed Investigational Site, Leonberg

73033

Altana Pharma/Nycomed Investigational Site, Göppingen

74889

Altana Pharma/Nycomed Investigational Site, Sinsheim

83000

Altana Pharma/Nycomed Investigational Site, Toulon

83190

Altana Pharma/Nycomed Investigational Site, Ollioules

86899

Altana Pharma/Nycomed Investigational Site, Landsberg/Lech

AD700

Altana Pharma/Nycomed Investigational Site, Escaldes-Engordany

TW15 3RN

Altana Pharma/Nycomed Investigational Site, Ashford

CV9 1EU

Altana Pharma/Nycomed Investigational Site, Atherstone, Warwick

CS62 7EB

Altana Pharma/Nycomed Investigational Site, Barry

TN40 1JJ

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

Unknown

Altana Pharma/Nycomed Investigational Site, Bolton

BL3 6TL

Altana Pharma/Nycomed Investigational Site, Bolton Lancs

S40 4TF

Altana Pharma/Nycomed Investigational Site, Chesterfield

Altana Pharma/Nycomed Investigational Site, Chesterfield Derbyshire

SN15 1HP

Altana Pharma/Nycomed Investigational Site, Chippenham

BT38 8TP

Altana Pharma/Nycomed Investigational Site, Co. Antrim

DL3 6HX

Altana Pharma/Nycomed Investigational Site, Darlington, Co. Durham

TN39 5HE

Altana Pharma/Nycomed Investigational Site, East Sussex

G45 9AW

Altana Pharma/Nycomed Investigational Site, Glasgow

HA3 7LT

Altana Pharma/Nycomed Investigational Site, Harrow

CV7 8LA

Altana Pharma/Nycomed Investigational Site, Keresely End, Coventry

PL6 7TH

Altana Pharma/Nycomed Investigational Site, Plymouth

S39DA

Altana Pharma/Nycomed Investigational Site, Sheffield

B91 2JL

Altana Pharma/Nycomed Investigational Site, Solihull

SN25 4YZ

Altana Pharma/Nycomed Investigational Site, Swindon, Wilts

BA14 9AR

Altana Pharma/Nycomed Investigational Site, Trowbridge

WD25 0EA

Altana Pharma/Nycomed Investigational Site, Watford

PE7 3JL

Altana Pharma/Nycomed Investigational Site, Yaxley

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY