Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,523

Participants

Timeline

Start Date

February 28, 2006

Primary Completion Date

July 31, 2008

Study Completion Date

September 30, 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 (179)

1134

Altana Pharma/Nycomed Investigational Site, Budapest

1221

Altana Pharma/Nycomed Investigational Site, Budapest

1475

Altana Pharma/Nycomed Investigational Site, Budapest

2100

Altana Pharma/Nycomed Investigational Site, Saint-Quentin

2139

Altana Pharma/Nycomed Investigational Site, Concord

2230

Altana Pharma/Nycomed Investigational Site, Gänserndorf

2303

Altana Pharma/Nycomed Investigational Site, Chauny

2660

Altana Pharma/Nycomed Investigational Site, Balassagyarmat

2900

Altana Pharma/Nycomed Investigational Site, Komárom

3001

Altana Pharma/Nycomed Investigational Site, Tauranga

4040

Altana Pharma/Nycomed Investigational Site, Linz

4043

Altana Pharma/Nycomed Investigational Site, Debrecen

4412

Altana Pharma/Nycomed Investigational Site, Nyiregyháza

5000

Altana Pharma/Nycomed Investigational Site, Adelaide South Australia

5400

Altana Pharma/Nycomed Investigational Site, Hallein

5703

Altana Pharma/Nycomed Investigational Site, Gyula

6000

Altana Pharma/Nycomed Investigational Site, Nice

6020

Altana Pharma/Nycomed Investigational Site, Innsbruck

6130

Altana Pharma/Nycomed Investigational Site, Grasse

6161

Altana Pharma/Nycomed Investigational Site, Natters

6700

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

6722

Altana Pharma/Nycomed Investigational Site, Szeged

7257

Altana Pharma/Nycomed Investigational Site, Mosdós

7621

Altana Pharma/Nycomed Investigational Site, Pécs

8300

Altana Pharma/Nycomed Investigational Site, Tapolca

8330

Altana Pharma/Nycomed Investigational Site, Feldbach

9200

Altana Pharma/Nycomed Investigational Site, Mosonmagyaróvár

9800

Altana Pharma/Nycomed Investigational Site, Spittal an der Drau

10029

Altana Pharma/Nycomed Investigational Site, New York

10100

Altana Pharma/Nycomed Investigational Site, Moscow

11025

Altana Pharma/Nycomed Investigational Site, Bucharest

13695

Altana Pharma/Nycomed Investigational Site, Martigues

19140

Altana Pharma/Nycomed Investigational Site, Philadelphia

20125

Altana Pharma/Nycomed Investigational Site, Bucharest

21224

Altana Pharma/Nycomed Investigational Site, Baltimore

21659

Altana Pharma/Nycomed Investigational Site, Bucharest

22908

Altana Pharma/Nycomed Investigational Site, Charlottesville, VA

23552

Altana Pharma/Nycomed Investigational Site, Lübeck

27103

Altana Pharma/Nycomed Investigational Site, Winston-Salem

30060

Altana Pharma/Nycomed Investigational Site, Marietta

30303

Altana Pharma/Nycomed Investigational Site, Bucharest

30309

Altana Pharma/Nycomed Investigational Site, Atlanta

30900

Altana Pharma/Nycomed Investigational Site, Nîmes

32405

Altana Pharma/Nycomed Investigational Site, Panama City

33176

Altana Pharma/Nycomed Investigational Site, Miami

33260

Altana Pharma/Nycomed Investigational Site, La Teste-de-Buch

33500

Altana Pharma/Nycomed Investigational Site, Libourne

33708

Altana Pharma/Nycomed Investigational Site, Bay Pines

34070

Altana Pharma/Nycomed Investigational Site, Montpellier

34121

Altana Pharma/Nycomed Investigational Site, Kassel

34295

Altana Pharma/Nycomed Investigational Site, Montpellier

35037

Altana Pharma/Nycomed Investigational Site, Marburg

36039

Altana Pharma/Nycomed Investigational Site, Fulda

40291

Altana Pharma/Nycomed Investigational Site, Lebanon

42000

Altana Pharma/Nycomed Investigational Site, Saint-Etienne

43215

Altana Pharma/Nycomed Investigational Site, Columbus

43614

Altana Pharma/Nycomed Investigational Site, Toledo

44501

Altana Pharma/Nycomed Investigational Site, Youngstown

45241

Altana Pharma/Nycomed Investigational Site, Cincinnati

46617

Altana Pharma/Nycomed Investigational Site, South Bend

50159

Altana Pharma/Nycomed Investigational Site, Bucharest

53717

Altana Pharma/Nycomed Investigational Site, Marietta

55407

Altana Pharma/Nycomed Investigational Site, Minneapolis

55435

Altana Pharma/Nycomed Investigational Site, Edina

57000

Altana Pharma/Nycomed Investigational Site, Metz

57950

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

59020

Altana Pharma/Nycomed Investigational Site, Lille

59102

Altana Pharma/Nycomed Investigational Site, Billings

59690

Altana Pharma/Nycomed Investigational Site, Vieux-Condé

59700

Altana Pharma/Nycomed Investigational Site, Marcq-en-Barœul

59804

Altana Pharma/Nycomed Investigational Site, Missoula

60141

Altana Pharma/Nycomed Investigational Site, Hines

62307

Altana Pharma/Nycomed Investigational Site, Lens

62660

Altana Pharma/Nycomed Investigational Site, Beuvry

63003

Altana Pharma/Nycomed Investigational Site, Clermont-Ferrand Cedex1

63017

Altana Pharma/Nycomed Investigational Site, Chesterfield

63117

Altana Pharma/Nycomed Investigational Site, St Louis

66046

Altana Pharma/Nycomed Investigational Site, Perpignan

68114

Altana Pharma/Nycomed Investigational Site, Omaha

68510

Altana Pharma/Nycomed Investigational Site, Lincoln

68723

Altana Pharma/Nycomed Investigational Site, Schwetzingen

69003

Altana Pharma/Nycomed Investigational Site, Lyon

70006

Altana Pharma/Nycomed Investigational Site, Metairie

70112

Altana Pharma/Nycomed Investigational Site, New Orleans

70461

Altana Pharma/Nycomed Investigational Site, Slidell

70584

Altana Pharma/Nycomed Investigational Site, Sunset

75231

Altana Pharma/Nycomed Investigational Site, Dallas

75877

Altana Pharma/Nycomed Investigational Site, Paris

77150

Altana Pharma/Nycomed Investigational Site, Ferolles-Attily

78750

Altana Pharma/Nycomed Investigational Site, Austin

83000

Altana Pharma/Nycomed Investigational Site, Toulon

83190

Altana Pharma/Nycomed Investigational Site, Ollioules

89502

Altana Pharma/Nycomed Investigational Site, Reno

90025

Altana Pharma/Nycomed Investigational Site, Los Angeles

90048

Altana Pharma/Nycomed Investigational Site, Los Angeles

92120

Altana Pharma/Nycomed Investigational Site, San Diego

92270

Altana Pharma/Nycomed Investigational Site, Rancho Mirage

92385

Altana Pharma/Nycomed Investigational Site, Fullerton

93551

Altana Pharma/Nycomed Investigational Site, Palmdale

94469

Altana Pharma/Nycomed Investigational Site, Deggendorf

97035

Altana Pharma/Nycomed Investigational Site, Lake Oswego

98225

Altana Pharma/Nycomed Investigational Site, Bellingham

105077

Altana Pharma/Nycomed Investigational Site, Moscow

105229

Altana Pharma/Nycomed Investigational Site, Moscow

109240

Altana Pharma/Nycomed Investigational Site, Moscow

111020

Altana Pharma/Nycomed Investigational Site, Moscow

115280

Altana Pharma/Nycomed Investigational Site, Moscow

115446

Altana Pharma/Nycomed Investigational Site, Moscow

117049

Altana Pharma/Nycomed Investigational Site, Moscow

118089

Altana Pharma/Nycomed Investigational Site, Moscow

121356

Altana Pharma/Nycomed Investigational Site, Moscow

123182

Altana Pharma/Nycomed Investigational Site, Moscow

129110

Altana Pharma/Nycomed Investigational Site, Moscow

143405

Altana Pharma/Nycomed Investigational Site, Moscow

193015

Altana Pharma/Nycomed Investigational Site, Saint Petersburg

194044

Altana Pharma/Nycomed Investigational Site, Saint Petersburg

194100

Altana Pharma/Nycomed Investigational Site, Saint Petersburg

194354

Altana Pharma/Nycomed Investigational Site, Saint Petersburg

196211

Altana Pharma/Nycomed Investigational Site, Saint Petersburg

1221020

Altana Pharma/Nycomed Investigational Site, São Paulo-SP

4023062

Altana Pharma/Nycomed Investigational Site, São Paulo-SP

5403900

Altana Pharma/Nycomed Investigational Site, São Paulo-SP

9060650

Altana Pharma/Nycomed Investigational Site, Santo André-SP

16618000

Altana Pharma/Nycomed Investigational Site, Botucatu - SP CEP

21941590

Altana Pharma/Nycomed Investigational Site, Rio de Janeiro-RJ

30130100

Altana Pharma/Nycomed Investigational Site, Belo Horizonte - MG CEP

36036110

Altana Pharma/Nycomed Investigational Site, Juiz de Fora-MG

80060900

Altana Pharma/Nycomed Investigational Site, Curitiba-PR

88040970

Altana Pharma/Nycomed Investigational Site, Florianópolis-SC

90035003

Altana Pharma/Nycomed Investigational Site, Porto Alegre-RS

90035074

Altana Pharma/Nycomed Investigational Site, Porto Alegre

90610000

Altana Pharma/Nycomed Investigational Site, Porto Alegre-RS

04401

Altana Pharma/Nycomed Investigational Site, Bangor

02777

Altana Pharma/Nycomed Investigational Site, North Dartmouth

08003

Altana Pharma/Nycomed Investigational Site, Cherry Hill

07081

Altana Pharma/Nycomed Investigational Site, Springfield

02920

Altana Pharma/Nycomed Investigational Site, Cranston

02914

Altana Pharma/Nycomed Investigational Site, East Providence

VIC 2138

Altana Pharma/Nycomed Investigational Site, Box Hill

NSW 2050

Altana Pharma/Nycomed Investigational Site, Camperdown

VIC 3168

Altana Pharma/Nycomed Investigational Site, Clayton

VIC 3220

Altana Pharma/Nycomed Investigational Site, Geelong

QLD 4021

Altana Pharma/Nycomed Investigational Site, Kippa-Ring

WA 6009

Altana Pharma/Nycomed Investigational Site, Nedlands

QLD 4101

Altana Pharma/Nycomed Investigational Site, South Brisbane

SA 5056

Altana Pharma/Nycomed Investigational Site, Toorak Gardens

SA 5034

Altana Pharma/Nycomed Investigational Site, Wayville

Unknown

Altana Pharma/Nycomed Investigational Site, Quadra 605 Brasilia - DF

Altana Pharma/Nycomed Investigational Site, Recife - PE

G69 7AD

Altana Pharma/Nycomed Investigational Site, Baillieston, Glasgow

BT19 1PP

Altana Pharma/Nycomed Investigational Site, Bangor, Northern Ireland

BA1 2SR

Altana Pharma/Nycomed Investigational Site, Bath

BA2 3HT

Altana Pharma/Nycomed Investigational Site, Bath, Avon

BT4 1NT

Altana Pharma/Nycomed Investigational Site, Belfast

B9 5SS

Altana Pharma/Nycomed Investigational Site, Birmingham

S40 4TF

Altana Pharma/Nycomed Investigational Site, Chesterfield

BT38 8TP

Altana Pharma/Nycomed Investigational Site, Co. Antrim

HU16 5JQ

Altana Pharma/Nycomed Investigational Site, Cottingham, E York

BT37 9QN

Altana Pharma/Nycomed Investigational Site, County Antrim

BT30 6HY

Altana Pharma/Nycomed Investigational Site, Downpatrick, Northern Ireland

TN39 5HE

Altana Pharma/Nycomed Investigational Site, East Sussex

TN40 1JJ

Altana Pharma/Nycomed Investigational Site, East Sussex

KY12 8SJ

Altana Pharma/Nycomed Investigational Site, Fife

G45 9AW

Altana Pharma/Nycomed Investigational Site, Glasgow

G46 8NY

Altana Pharma/Nycomed Investigational Site, Glasgow

BT36 5EQ

Altana Pharma/Nycomed Investigational Site, Glengormley Newtownabbey

HA3 7LT

Altana Pharma/Nycomed Investigational Site, Harrow

CT5 1BZ

Altana Pharma/Nycomed Investigational Site, Kent

L9 7AL

Altana Pharma/Nycomed Investigational Site, Liverpool

NG5 1PB

Altana Pharma/Nycomed Investigational Site, Nottingham

NG7 2UH

Altana Pharma/Nycomed Investigational Site, Nottingham

BT41 3AE

Altana Pharma/Nycomed Investigational Site, Randalstown

CV324RA

Altana Pharma/Nycomed Investigational Site, Royal Leamington Spa

S39DA

Altana Pharma/Nycomed Investigational Site, Sheffield

B91 2JL

Altana Pharma/Nycomed Investigational Site, Solihull

SO16 6YD

Altana Pharma/Nycomed Investigational Site, Southampton

BA2 1NH

Altana Pharma/Nycomed Investigational Site, Southdown, Bath

TW16 6RH

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

CF64 2XX

Altana Pharma/Nycomed Investigational Site, Vale of Glamorgan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY

NCT00297102 - Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124) | Biotech Hunter | Biotech Hunter