Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The HERMES Study (BY217/M2-125)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,568

Participants

Timeline

Start Date

March 31, 2006

Primary Completion Date

April 30, 2008

Study Completion Date

August 31, 2008

Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Interventions
DRUG

Roflumilast

500 mcg, once daily, oral administration in the morning

DRUG

Placebo

once daily

Trial Locations (287)

12

Altana Pharma/Nycomed Investigational Site, Hyderabad

44

Altana Pharma/Nycomed Investigational Site, C/O Netcare & Garsfontein Roads

135

Altana Pharma/Nycomed Investigational Site, Roma

181

Altana Pharma/Nycomed Investigational Site, Pretoria

594

Altana Pharma/Nycomed Investigational Site, Rincon

1140

Altana Pharma/Nycomed Investigational Site, Warsaw

2919

Altana Pharma/Nycomed Investigational Site, Johnston

3114

Altana Pharma/Nycomed Investigational Site, Partida de Bacarot (Alicante)

3600

Altana Pharma/Nycomed Investigational Site, Elda

4000

Altana Pharma/Nycomed Investigational Site, Berea, Durban

4126

Altana Pharma/Nycomed Investigational Site, Durban, Amanzimtoti

6080

Altana Pharma/Nycomed Investigational Site, Badajoz

6108

Altana Pharma/Nycomed Investigational Site, Halle

6708

Altana Pharma/Nycomed Investigational Site, Waterbury

6800

Altana Pharma/Nycomed Investigational Site, Merida (Badajoz)

7130

Altana Pharma/Nycomed Investigational Site, Somerset West

7505

Altana Pharma/Nycomed Investigational Site, Cape Town, Tygerberg

7530

Altana Pharma/Nycomed Investigational Site, Bellville, Cape Town

7550

Altana Pharma/Nycomed Investigational Site, Durbanville / Cape Town

7626

Altana Pharma/Nycomed Investigational Site, Paarl, Cape Town

7764

Altana Pharma/Nycomed Investigational Site, Cape Town

7925

Altana Pharma/Nycomed Investigational Site, Mowbray, Cape Town

8001

Altana Pharma/Nycomed Investigational Site, Cape Town

8221

Altana Pharma/Nycomed Investigational Site, Tarrasa (Barcelona)

9301

Altana Pharma/Nycomed Investigational Site, Bloemfontein

10559

Altana Pharma/Nycomed Investigational Site, Berlin

10717

Altana Pharma/Nycomed Investigational Site, Berlin

10965

Altana Pharma/Nycomed Investigational Site, Berlin

10969

Altana Pharma/Nycomed Investigational Site, Berlin

11040

Altana Pharma/Nycomed Investigational Site, New Hyde Park

11042

Altana Pharma/Nycomed Investigational Site, New Hyde Park

12165

Altana Pharma/Nycomed Investigational Site, Berlin

12203

Altana Pharma/Nycomed Investigational Site, Berlin

13031

Altana Pharma/Nycomed Investigational Site, Camillus

13045

Altana Pharma/Nycomed Investigational Site, Cortland

13210

Altana Pharma/Nycomed Investigational Site, Syracuse

13507

Altana Pharma/Nycomed Investigational Site, Berlin

13597

Altana Pharma/Nycomed Investigational Site, Berlin

14464

Altana Pharma/Nycomed Investigational Site, Potsdam

14467

Altana Pharma/Nycomed Investigational Site, Potsdam

14830

Altana Pharma/Nycomed Investigational Site, Corning

15221

Altana Pharma/Nycomed Investigational Site, Pittsburgh

15562

Altana Pharma/Nycomed Investigational Site, Rüdersdorf

15706

Altana Pharma/Nycomed Investigational Site, Santiago de Compostela

16153

Altana Pharma/Nycomed Investigational Site, Stoneboro

16506

Altana Pharma/Nycomed Investigational Site, Erie

16816

Altana Pharma/Nycomed Investigational Site, Neuruppin

17033

Altana Pharma/Nycomed Investigational Site, Hershey

19002

Altana Pharma/Nycomed Investigational Site, Guadalajara

19081

Altana Pharma/Nycomed Investigational Site, Swarthmore

19107

Altana Pharma/Nycomed Investigational Site, Philadelphia

19140

Altana Pharma/Nycomed Investigational Site, Philadelphia

20017

Altana Pharma/Nycomed Investigational Site, Washington D.C.

20142

Altana Pharma/Nycomed Investigational Site, Milan

20535

Altana Pharma/Nycomed Investigational Site, Hamburg

21044

Altana Pharma/Nycomed Investigational Site, Columbia

22927

Altana Pharma/Nycomed Investigational Site, Großhansdorf

24100

Altana Pharma/Nycomed Investigational Site, Bergamo

24501

Altana Pharma/Nycomed Investigational Site, Lynchburg

25304

Altana Pharma/Nycomed Investigational Site, Charleston

27100

Altana Pharma/Nycomed Investigational Site, Pavia

27103

Altana Pharma/Nycomed Investigational Site, Winston-Salem

27210

Altana Pharma/Nycomed Investigational Site, Calde (Lugo)

28006

Altana Pharma/Nycomed Investigational Site, Madrid

28010

Altana Pharma/Nycomed Investigational Site, Veruno

28041

Altana Pharma/Nycomed Investigational Site, Madrid

28070

Altana Pharma/Nycomed Investigational Site, Huntersville

28207

Altana Pharma/Nycomed Investigational Site, Charlotte

28905

Altana Pharma/Nycomed Investigational Site, Getafe

29379

Altana Pharma/Nycomed Investigational Site, Union

29406

Altana Pharma/Nycomed Investigational Site, Charleston

29605

Altana Pharma/Nycomed Investigational Site, Greenville

29615

Altana Pharma/Nycomed Investigational Site, Greenville

29651

Altana Pharma/Nycomed Investigational Site, Greer

29697

Altana Pharma/Nycomed Investigational Site, Williamston

30033

Altana Pharma/Nycomed Investigational Site, Decatur

30060

Altana Pharma/Nycomed Investigational Site, Marietta

30203

Altana Pharma/Nycomed Investigational Site, Cartagena

30342

Altana Pharma/Nycomed Investigational Site, Atlanta

30513

Altana Pharma/Nycomed Investigational Site, Blue Ridge

30905

Altana Pharma/Nycomed Investigational Site, Fort Gordon

31202

Altana Pharma/Nycomed Investigational Site, Krakow

31406

Altana Pharma/Nycomed Investigational Site, Savannah

31901

Altana Pharma/Nycomed Investigational Site, Columbus

32174

Altana Pharma/Nycomed Investigational Site, Ormand Beach

32204

Altana Pharma/Nycomed Investigational Site, Jacksonville

32500

Altana Pharma/Nycomed Investigational Site, Chrzanów

32720

Altana Pharma/Nycomed Investigational Site, DeLand

32960

Altana Pharma/Nycomed Investigational Site, Vero Beach

33127

Altana Pharma/Nycomed Investigational Site, Port Orange

33140

Altana Pharma/Nycomed Investigational Site, Miami Beach

33173

Altana Pharma/Nycomed Investigational Site, Miami

33176

Altana Pharma/Nycomed Investigational Site, Miami

33316

Altana Pharma/Nycomed Investigational Site, Fort Lauderdale

33321

Altana Pharma/Nycomed Investigational Site, Tamarac

33756

Altana Pharma/Nycomed Investigational Site, Clearwater

34100

Altana Pharma/Nycomed Investigational Site, Trieste

34471

Altana Pharma/Nycomed Investigational Site, Ocala

35249

Altana Pharma/Nycomed Investigational Site, Birmingham

35294

Altana Pharma/Nycomed Investigational Site, Birmingham

35801

Altana Pharma/Nycomed Investigational Site, Huntsville

36071

Altana Pharma/Nycomed Investigational Site, Pontevedra

36509

Altana Pharma/Nycomed Investigational Site, Bayou La Batre

37100

Altana Pharma/Nycomed Investigational Site, Verona

37203

Altana Pharma/Nycomed Investigational Site, Nashville

37604

Altana Pharma/Nycomed Investigational Site, Johnson City

37825

Altana Pharma/Nycomed Investigational Site, New Tazewell

37920

Altana Pharma/Nycomed Investigational Site, Knoxville

38163

Altana Pharma/Nycomed Investigational Site, Memphis

39387

Altana Pharma/Nycomed Investigational Site, Oschersleben

40136

Altana Pharma/Nycomed Investigational Site, Bologna

40207

Altana Pharma/Nycomed Investigational Site, Louisville

41701

Altana Pharma/Nycomed Investigational Site, Hazard

42200

Altana Pharma/Nycomed Investigational Site, Częstochowa

42718

Altana Pharma/Nycomed Investigational Site, Campbellsville

43100

Altana Pharma/Nycomed Investigational Site, Parma

43215

Altana Pharma/Nycomed Investigational Site, Columbus

43560

Altana Pharma/Nycomed Investigational Site, Sylvania

43608

Altana Pharma/Nycomed Investigational Site, Toledo

43614

Altana Pharma/Nycomed Investigational Site, Toledo

43617

Altana Pharma/Nycomed Investigational Site, Toledo

44300

Altana Pharma/Nycomed Investigational Site, Wodzisław Śląski

44718

Altana Pharma/Nycomed Investigational Site, Canton

45004

Altana Pharma/Nycomed Investigational Site, Toldeo

45231

Altana Pharma/Nycomed Investigational Site, Cincinnati

45600

Altana Pharma/Nycomed Investigational Site, Talavera de La Reina (Toledo)

46015

Altana Pharma/Nycomed Investigational Site, Valencia

46017

Altana Pharma/Nycomed Investigational Site, Valencia

46202

Altana Pharma/Nycomed Investigational Site, Indianapolis

46254

Altana Pharma/Nycomed Investigational Site, Indianapolis

46340

Altana Pharma/Nycomed Investigational Site, Requena

46514

Altana Pharma/Nycomed Investigational Site, Elkhart

47150

Altana Pharma/Nycomed Investigational Site, New Albany

48114

Altana Pharma/Nycomed Investigational Site, Brighton

48152

Altana Pharma/Nycomed Investigational Site, Livonia

48602

Altana Pharma/Nycomed Investigational Site, Saginaw

49002

Altana Pharma/Nycomed Investigational Site, Portage

49643

Altana Pharma/Nycomed Investigational Site, Interlochen

50134

Altana Pharma/Nycomed Investigational Site, Florence

50501

Altana Pharma/Nycomed Investigational Site, Fort Dodge

50702

Altana Pharma/Nycomed Investigational Site, Waterloo

52001

Altana Pharma/Nycomed Investigational Site, Dubuque

52242

Altana Pharma/Nycomed Investigational Site, Iowa City

53212

Altana Pharma/Nycomed Investigational Site, Glendale

53217

Altana Pharma/Nycomed Investigational Site, Glendale

55407

Altana Pharma/Nycomed Investigational Site, Minneapolis

55435

Altana Pharma/Nycomed Investigational Site, Edina

55805

Altana Pharma/Nycomed Investigational Site, Duluth

55905

Altana Pharma/Nycomed Investigational Site, Rochester

59701

Altana Pharma/Nycomed Investigational Site, Butte

59718

Altana Pharma/Nycomed Investigational Site, Bozeman

60007

Altana Pharma/Nycomed Investigational Site, Elk Grove Village

60064

Altana Pharma/Nycomed Investigational Site, North Chicago

60305

Altana Pharma/Nycomed Investigational Site, River Forest

60611

Altana Pharma/Nycomed Investigational Site, Chicago

61603

Altana Pharma/Nycomed Investigational Site, Peoria

61820

Altana Pharma/Nycomed Investigational Site, Champaign

63017

Altana Pharma/Nycomed Investigational Site, Chesterfield

63122

Altana Pharma/Nycomed Investigational Site, St Louis

63141

Altana Pharma/Nycomed Investigational Site, St Louis

64106

Altana Pharma/Nycomed Investigational Site, Kansas City

64111

Altana Pharma/Nycomed Investigational Site, Kansas City

65101

Altana Pharma/Nycomed Investigational Site, Jefferson City

66061

Altana Pharma/Nycomed Investigational Site, Olathe

66606

Altana Pharma/Nycomed Investigational Site, Topeka

68131

Altana Pharma/Nycomed Investigational Site, Omaha

70006

Altana Pharma/Nycomed Investigational Site, Metairie

70020

Altana Pharma/Nycomed Investigational Site, Cassano Murge

70584

Altana Pharma/Nycomed Investigational Site, Sunset

71291

Altana Pharma/Nycomed Investigational Site, West Monroe

72205

Altana Pharma/Nycomed Investigational Site, Little Rock

72917

Altana Pharma/Nycomed Investigational Site, Fort Smith

73120

Altana Pharma/Nycomed Investigational Site, Oklahoma City

75069

Altana Pharma/Nycomed Investigational Site, McKinney

75110

Altana Pharma/Nycomed Investigational Site, Corsicana

75708

Altana Pharma/Nycomed Investigational Site, Tyler

76054

Altana Pharma/Nycomed Investigational Site, Hurst

76109

Altana Pharma/Nycomed Investigational Site, Fort Worth

77005

Altana Pharma/Nycomed Investigational Site, Houston

77024

Altana Pharma/Nycomed Investigational Site, Houston

78006

Altana Pharma/Nycomed Investigational Site, Boerne

78155

Altana Pharma/Nycomed Investigational Site, Seguin

78205

Altana Pharma/Nycomed Investigational Site, San Antonio

78229

Altana Pharma/Nycomed Investigational Site, San Antonio

80206

Altana Pharma/Nycomed Investigational Site, Denver

83301

Altana Pharma/Nycomed Investigational Site, Twin Falls

84107

Altana Pharma/Nycomed Investigational Site, Salt Lake City

84124

Altana Pharma/Nycomed Investigational Site, Salt Lake City

85012

Altana Pharma/Nycomed Investigational Site, Phoenix

85023

Altana Pharma/Nycomed Investigational Site, Phoenix

85442

Altana Pharma/Nycomed Investigational Site, Bullhead City

86899

Altana Pharma/Nycomed Investigational Site, Landsberg/Lech

89073

Altana Pharma/Nycomed Investigational Site, Ulm

89123

Altana Pharma/Nycomed Investigational Site, Las Vegas

89176

Altana Pharma/Nycomed Investigational Site, Las Vegas

90033

Altana Pharma/Nycomed Investigational Site, Los Angeles

90712

Altana Pharma/Nycomed Investigational Site, Lakewood

90720

Altana Pharma/Nycomed Investigational Site, Los Alamitos

90822

Altana Pharma/Nycomed Investigational Site, Long Beach

91343

Altana Pharma/Nycomed Investigational Site, Sepulveda

91505

Altana Pharma/Nycomed Investigational Site, Burbank

92008

Altana Pharma/Nycomed Investigational Site, Carlsbad

92103

Altana Pharma/Nycomed Investigational Site, San Diego

92120

Altana Pharma/Nycomed Investigational Site, San Diego

92801

Altana Pharma/Nycomed Investigational Site, Anaheim

93059

Altana Pharma/Nycomed Investigational Site, Regensburg

93093

Altana Pharma/Nycomed Investigational Site, Donaustauf

93720

Altana Pharma/Nycomed Investigational Site, Fresno

95100

Altana Pharma/Nycomed Investigational Site, Zgierz

95207

Altana Pharma/Nycomed Investigational Site, Stockton

95678

Altana Pharma/Nycomed Investigational Site, Roseville

95831

Altana Pharma/Nycomed Investigational Site, Sacramento

97220

Altana Pharma/Nycomed Investigational Site, Portland

97504

Altana Pharma/Nycomed Investigational Site, Medford

98104

Altana Pharma/Nycomed Investigational Site, Seattle

99216

Altana Pharma/Nycomed Investigational Site, Spokane

400022

Altana Pharma/Nycomed Investigational Site, Mumbai

411033

Altana Pharma/Nycomed Investigational Site, Pune

440012

Altana Pharma/Nycomed Investigational Site, Nagpur

452001

Altana Pharma/Nycomed Investigational Site, Indore, South Tukuganj

570004

Altana Pharma/Nycomed Investigational Site, Mysore

02114

Altana Pharma/Nycomed Investigational Site, Boston

08201

Altana Pharma/Nycomed Investigational Site, Absecon

08610

Altana Pharma/Nycomed Investigational Site, Hamilton

08880

Altana Pharma/Nycomed Investigational Site, South Bound Brook

T2N 4N1

Altana Pharma/Nycomed Investigational Site, Calgary

T3C 3P1

Altana Pharma/Nycomed Investigational Site, Calgary

T5C 0A3

Altana Pharma/Nycomed Investigational Site, Edmonton

T7X 2Z8

Altana Pharma/Nycomed Investigational Site, Spruce Grove

V5G 1T4

Altana Pharma/Nycomed Investigational Site, Burnaby

V2A 5C8

Altana Pharma/Nycomed Investigational Site, Penticton

V5Z 4E1

Altana Pharma/Nycomed Investigational Site, Vancouver

B2N 1L2

Altana Pharma/Nycomed Investigational Site, Truro

N7M 1R2

Altana Pharma/Nycomed Investigational Site, Chatham

L8M 1K7

Altana Pharma/Nycomed Investigational Site, Hamilton

N5Y 5K7

Altana Pharma/Nycomed Investigational Site, London

L5M 2V8

Altana Pharma/Nycomed Investigational Site, Mississauga

K1Y 4E9

Altana Pharma/Nycomed Investigational Site, Ottawa

N7T 4X3

Altana Pharma/Nycomed Investigational Site, Sarnia

M1B 4Z8

Altana Pharma/Nycomed Investigational Site, Scarborough Village

M5S 2A5

Altana Pharma/Nycomed Investigational Site, Toronto

H1V 1X5

Altana Pharma/Nycomed Investigational Site, Montreal

H3S 2W1

Altana Pharma/Nycomed Investigational Site, Montreal

G6W 5M6

Altana Pharma/Nycomed Investigational Site, Saint Romuald

G1V4G5

Altana Pharma/Nycomed Investigational Site, Sainte-Foy

J1H 4J6

Altana Pharma/Nycomed Investigational Site, Sherbrooke

G1W 4R4

Altana Pharma/Nycomed Investigational Site, Ste-Foy

B2G2C2

Altana Pharma/Nycomed Investigational Site, Antigonish

B4V3N2

Altana Pharma/Nycomed Investigational Site, Bridgewater

T1Y6J4

Altana Pharma/Nycomed Investigational Site, Calgary

N0N1G0

Altana Pharma/Nycomed Investigational Site, Corunna

T5N4L8

Altana Pharma/Nycomed Investigational Site, Edmonton

L2A1Z3

Altana Pharma/Nycomed Investigational Site, Fort Erie

L3M1P3

Altana Pharma/Nycomed Investigational Site, Grimsby

L8N3Z5

Altana Pharma/Nycomed Investigational Site, Hamilton

J4N1E1

Altana Pharma/Nycomed Investigational Site, Longueuil

H2L2W5

Altana Pharma/Nycomed Investigational Site, Montreal

L2R2Z9

Altana Pharma/Nycomed Investigational Site, Ontario

L4C2N9

Altana Pharma/Nycomed Investigational Site, Richmond Hill

E3M3W5

Altana Pharma/Nycomed Investigational Site, Saint John

J7Z5T3

Altana Pharma/Nycomed Investigational Site, Saint-Jérôme

H1S3A9

Altana Pharma/Nycomed Investigational Site, Saint-Léonard

J1H5N4

Altana Pharma/Nycomed Investigational Site, Sherbrooke

M5G1X5

Altana Pharma/Nycomed Investigational Site, Toronto

R2K3S8

Altana Pharma/Nycomed Investigational Site, Winnipeg

560 002

Altana Pharma/Nycomed Investigational Site, Bangalore

560 034

Altana Pharma/Nycomed Investigational Site, Bangalore

560 029

Altana Pharma/Nycomed Investigational Site, Bangalore, Karnataka

600 034

Altana Pharma/Nycomed Investigational Site, Chennai

641 004

Altana Pharma/Nycomed Investigational Site, Coimbatore

641 014

Altana Pharma/Nycomed Investigational Site, Coimbatore

641 044

Altana Pharma/Nycomed Investigational Site, Coimbatore, Tamilnadu

403 002

Altana Pharma/Nycomed Investigational Site, Goa

574 160

Altana Pharma/Nycomed Investigational Site, Mangalore

575 001

Altana Pharma/Nycomed Investigational Site, Mangalore

400 008

Altana Pharma/Nycomed Investigational Site, Mumbai, Byculla

400 014

Altana Pharma/Nycomed Investigational Site, Mumbai, Dadar (E)

440 012

Altana Pharma/Nycomed Investigational Site, Nagpur

440 013

Altana Pharma/Nycomed Investigational Site, Nagpur

411 014

Altana Pharma/Nycomed Investigational Site, Pune

302 016

Altana Pharma/Nycomed Investigational Site, Shastri Nagar, Jaipur

13-200

Altana Pharma/Nycomed Investigational Site, Działdowo

40-752

Altana Pharma/Nycomed Investigational Site, Katowice

31-202

Altana Pharma/Nycomed Investigational Site, Krakow

20-718

Altana Pharma/Nycomed Investigational Site, Lublin

60-569

Altana Pharma/Nycomed Investigational Site, Poznan

01-138

Altana Pharma/Nycomed Investigational Site, Warsaw

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY