Efficacy, Safety and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28-Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)

PHASE3CompletedINTERVENTIONAL
Enrollment

921

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

June 30, 2013

Study Completion Date

June 30, 2013

Conditions
Chronic Obstructive Pulmonary Disease
Interventions
DRUG

Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)

Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose, twice per day

DRUG

Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)

Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose, twice per day

DRUG

Aclidinium bromide

Inhaled Aclidinium bromide 400 μg, twice per day

DRUG

Formoterol Fumarate

Inhaled Formoterol Fumarate 12 μg, twice per day

DRUG

Placebo

Inhaled dose-matched placebo, twice per day

Trial Locations (208)

1051

Forest Investigative Site 1027, Auckland

2305

Forest Investigative Site 1991, New Lambton

3050

Forest Investigative Site 1985, Parkville

3065

Forest Investigative Site 1972, Fitzroy

3110

Forest Investigative Site 1965, Tauranga

3112

Forest Investigative Site 1980, Tauranga

3168

Forest Investigative Site 2250, Clayton

3220

Forest Investigative Site 1986, Geelong

3240

Forest Investigative Site 1968, Hamilton

4020

Forest Investigative Site 1987, Redcliffe

4102

Forest Investigative Site 1973, Woolloongabba

5000

Forest Investigative Site 2253, Adelaide

5041

Forest Investigative Site 1990, Daw Park

5042

Forest Investigative Site 1981, Bedford Park

5065

Forest Investigative Site 2251, Toorak Gardens

7366

Forest Investigative Site 1025, Wellington

8011

Forest Investigative Site 1970, Christchurch

9012

Forest Investigative Site 1967, Dunedin

9058

Forest Investigative Site 1964, Dunedin

10003

Forest Investigative Site 550, New York

10028

Forest Investigative Site 1425, New York

10538

Forest Investigative Site 1489, Larchmont

11021

Forest Investigative Site 1151, Great Neck

14618

Forest Investigative Site 2098, Rochester

15243

Forest Investigative Site 1146, Pittsburgh

15473

Forest Investigative Site 1862, Uniontown

16508

Forest Investigative Site 1423, Erie

16601

Forest Investigative Site 1833, Altoona

16684

Forest Investigative Site 1449, Tipton

19047

Forest Investigative Site 1899, Langhorne

19107

Forest Investigative Site 1443, Philadelphia

19335

Forest Investigative Site 1820, Downington

19460

Forest Investigative Site 1863, Phoenixville

20902

Forest Investigative Site 1872, Wheaton

21237

Forest Investigative Site 1924, Baltimore

23502

Forest Investigative Site 1404, Norfolk

23606

Forest Investigative Site 1945, Newport News

26505

Forest Investigative Site 1555, Morgantown

27262

Forest Investigative Site 1366, High Point

27607

Forest Investigative Site 1153, Raleigh

27909

Forest Investigative Site 2035, Elizabeth City

28144

Forest Investigative Site 1823, Salisbury

28277

Forest Investigative Site 1392, Charlotte

29303

Forest Investigative Site 1121, Spartanburg

29340

Forest Investigative Site 1913, Gaffney

29406

Forest Investigative Site 2072, Charleston

29407

Forest Investigative Site 1905, Charleston

29412

Forest Investigative Site 1802, Charleston

29707

Forest Investigative Site 1914, Fort Mill

30066

Forest Investigative Site 1830, Marietta

30106

Forest Investigative Site 0987, Austell

30114

Forest Investigative Site 1828, Canton

30189

Forest Investigative Site 2089, Woodstock

30312

Forest Investigative Site 1900, Atlanta

32028

Forest Investigative Site 1803, Pembroke Pines

32132

Forest Investigative Site 1516, Edgewater

32174

Forest Investigative Site 1145, Ormond Beach

32216

Forest Investigative Site 1543, Jacksonville

32405

Forest Investigative Site 1094, Panama City

32504

Forest Investigative Site 0974, Pensacola

32720

Forest Investigative Site 0670, DeLand

32789

Forest Investigative Site 1185, Winter Park

32792

Forest Investigative Site 1860, Winter Park

32935

Forest Investigative Site 1167, Melbourne

33012

Forest Investigative Site 1513, Hialeah

Forest Investigative Site 1854, Hialeah

33024

Forest Investigative Site 1882, Hollywood

33143

Forest Investigative Site 1432, Miami

33179

Forest Investigative Site 1808, North Miami

33316

Forest Investigative Site 0990, Fort Lauderdale

33321

Forest Investigative Site 2082, Tamarac

33511

Forest Investigative Site 1154, Brandon

Forest Investigative Site 1944, Brandon

33603

Forest Investigative Site 2053, Tampa

33613

Forest Investigative Site 2047, Tampa

33704

Forest Investigative Site 1874, St. Petersburg

33744

Forest Investigative Site 1821, Bay Pines

33756

Forest Investigative Site 1364, Clearwater

33765

Forest Investigative Site 1152, Clearwater

Forest Investigative Site 1875, Clearwater

34119

Forest Investigative Site 1819, Naples

34233

Forest Investigative Site 1817, Sarasota

34677

Forest Investigative Site 1950, Oldsmar

34741

Forest Investigative Site 1416, Kissimmee

35209

Forest Investigative Site 1162, Birmingham

Forest Investigative Site 1493, Birmingham

35216

Forest Investigative Site 1937, Birmingham

35501

Forest Investigative Site 2088, Jasper

35611

Forest Investigative Site 1920, Athens

35768

Forest Investigative Site 1918, Scottsboro

36207

Forest Investigative Site 1827, Anniston

36542

Forest Investigative Site 1824, Gulf Shores

37027

Forest Investigative Site 1957, Brentwood

37334

Forest Investigative Site 1526, Fayetteville

38654

Forest Investigative Site 1884, Olive Branch

40217

Forest Investigative Site 1478, Louisville

40504

Forest Investigative Site 0539, Lexington

41017

Forest Investigative Site 2085, Fort Mitchell

42101

Forest Investigative Site 2033, Bowling Green

42303

Forest Investigative Site 1519, Owensboro

43207

Forest Investigative Site 1361, Columbus

43213

Forest Investigative Site 1433, Columbus

43560

Forest Investigative Site 2090, Sylvania

43608

Forest Investigative Site 1530, Toledo

43701

Forest Investigative Site 1393, Zanesville

43907

Forest Investigative Site 1891, Cadiz

44718

Forest Investigative Site 1134, Canton

45219

Forest Investigative Site 1885, Cincinnati

45231

Forest Investigative Site 1806, Cincinnati

45242

Forest Investigative Site 2028, Cincinnati

45255

Forest Investigative Site 1903, Cincinnati

48085

Forest Investigative Site 1487, Troy

48106

Forest Investigative Site 1892, Ann Arbor

49127

Forest Investigative Site 1342, Stevensville

55402

Forest Investigative Site 2041, Minneapolis

55407

Forest Investigative Site 1124, Minneapolis

55432

Forest Investigative Site 1527, Fridley

55435

Forest Investigative Site 1128, Edina

55441

Forest Investigative Site 1619, Plymouth

55905

Forest Investigative Site 1118, Rochester

59718

Forest Investigative Site 1831, Bozeman

59808

Forest Investigative Site 1400, Missoula

60305

Forest Investigative Site 2051, River Forest

61761

Forest Investigative Site 1095, Normal

Forest Investigative Site 1912, Normal

63017

Forest Investigative Site 1587, N. Chesterfield

63141

Forest Investigative Site 1399, St Louis

Forest Investigative Site 1599, St Louis

63301

Forest Investigative Site 2079, Saint Charles

64128

Forest Investigative Site 1602, Kansas City

65807

Forest Investigative Site 1856, Springfield

Forest Investigative Site 1867, Springfield

68025

Forest Investigative Site 1948, Fremont

68114

Forest Investigative Site 1363, Omaha

68123

Forest Investigative Site 1609, Bellevue

68130

Forest Investigative Site 1907, Omaha

68131

Forest Investigative Site 1911, Omaha

68134

Forest Investigative Site 1908, Omaha

68144

Forest Investigative Site 1804, Omaha

68510

Forest Investigative Site 1815, Lincoln

70115

Forest Investigative Site 1430, New Orleans

70433

Forest Investigative Site 1811, Covington

70570

Forest Investigative Site 1812, Opelousas

73103

Forest Investigative Site 1915, Oklahoma City

75001

Forest Investigative Site 1826, Plano

75007

Forest Investigative Site 1861, Carrollton

75069

Forest Investigative Site 1091, McKinney

75110

Forest Investigative Site 1816, Corsicana

75220

Forest Investigative Site 1890, Dallas

76012

Forest Investigative Site 1440, Arlington

76104

Forest Investigative Site 2012, Fort Worth

77070

Forest Investigative Site 1951, Houston

78006

Forest Investigative Site 1879, Boerne

78212

Forest Investigative Site 1895, San Antonio

79903

Forest Investigative Site 1332, El Paso

80033

Forest Investigative Site 1327, Wheat Ridge

80401

Forest Investigative Site 1380, Golden

81001

Forest Investigative Site 1137, Pueblo

83616

Forest Investigative Site 1858, Eagle

83814

Forest Investigative Site 0679, Coeur d'Alene

84102

Forest Investigative Site 1936, Salt Lake City

85018

Forest Investigative Site 1379, Phoenix

85306

Forest Investigative Site 0909, Glendale

87106

Forest Investigative Site 1949, Albuquerque

89052

Forest Investigative Site 1807, Henderson

89128

Forest Investigative Site 1834, Las Vegas

89183

Forest Investigative Site 1562, Las Vegas

90073

Forest Investigative Site 1873, Los Angeles

90505

Forest Investigative Site 1374, Torrance

90620

Forest Investigative Site 1483, Buena Park

92083

Forest Investigative Site 1883, Vista

92103

Forest Investigative Site 1125, San Diego

92120

Forest Investigative Site 2009, San Diego

92506

Forest Investigative Site 2064, Riverside

92780

Forest Investigative Site 1813, Tustin

92801

Forest Investigative Site 1822, Anaheim

93726

Forest Investigative Site 1156, Fresno

95648

Forest Investigative Site 1871, Lincoln

95817

Forest Investigative Site 1427, Sacramento

95842

Forest Investigative Site 1866, Sacramento

97504

Forest Investigative Site 2043, Medford

97701

Forest Investigative Site 1889, Bend

98225

Forest Investigative Site 1120, Bellingham

98405

Forest Investigative Site 0988, Tacoma

Forest Investigative Site 1870, Tacoma

99202

Forest Investigative Site 1977, Spokane

99204

Forest Investigative Site 1878, Spokane

99216

Forest Investigative Site 1573, Spokane

06708

Forest Investigative Site 1976, Waterbury

04401

Forest Investigative Site 1814, Bangor

02720

Forest Investigative Site 1570, Fall River

Forest Investigative Site 1852, Fall River

02747

Forest Investigative Site 1431, No. Dartmouth

08003

Forest Investigative Site 1559, Cherry Hill

07601

Forest Investigative Site 1923, Hackensack

02864

Forest Investigative Site 1832, Cumberland

02914

Forest Investigative Site 1089, East Providence

05403

Forest Investigative Site 1330, South Burlington

V3A 4H9

Forest Investigative Site 1904, Langley

V5Z 1M9

Forest Investigative Site 905, Vancouver

R2K 3S8

Forest Investigative Site 0976, Winnipeg

N7T 4X3

Forest Investigative Site 1877, Sarina

Forest Investigative Site 1896, Sarnia

M5T 3A9

Forest Investigative Site 1171, Toronto

M6H 3M2

Forest Investigative Site 2203, Toronto

H2R 1V6

Forest Investigative Site 1952, Montreal

G1V 4M6

Forest Investigative Site 1859, Québec

S7N 0W8

Forest Investigative Site 0943, Saskatoon

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

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