A Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Period in Subjects With Moderate to Very Severe COPD (Sophos)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,876

Participants

Timeline

Start Date

April 29, 2016

Primary Completion Date

April 4, 2018

Study Completion Date

April 4, 2018

Conditions
Chronic Obstructive Pulmonary Disorder
Interventions
DRUG

BFF MDI (PT009) 320/9.6 μg

Blinded Treatment

DRUG

BFF MDI (PT009) 160/9.6 μg

Blinded Treatment

DRUG

FF MDI (PT005) 9.6 μg

Blinded Treatment

Trial Locations (282)

41

Research Site, Lima

184

Research Site, Pretoria

1070

Research Site, Brussels

1425

Research Site, Ciudad de Buenos Aires

1426

Research Site, CABA

Research Site, Ciudad Autonomade Buenos Aires

1646

Research Site, San Fernando

1730

Research Site, Cape Town

1820

Research Site, Lenasia Ext8

1886

Research Site, Ranelagh

1888

Research Site, San Juan Bautista

2001

Research Site, Johannesburg

2400

Research Site, København NV

2650

Research Site, Hvidovre

3060

Research Site, Svelvik

3260

Research Site, Concepción del Uruguay

4000

Research Site, San Miguel de Tucumán

Research Site, Liège

Research Site, Roskilde

4001

Research Site, Durban

4450

Research Site, KwaDukuza

4841

Research Site, Arendal

5000

Research Site, Odense C

5100

Research Site, Jambes

5101

Research Site, Erpent

5400

Research Site, Hallein

5500

Research Site, Mendoza

6000

Research Site, Kolding

6060

Research Site, Gilly

6700

Research Site, Bludenz

6760

Research Site, Mexico City

7030

Research Site, Trondheim

7570

Research Site, Cape Town

7600

Research Site, Mar del Plata

7700

Research Site, Mowbray

7764

Research Site, Cape Town

8200

Research Site, Aarhus N

8600

Research Site, Silkeborg

8800

Research Site, Roeselare

9000

Research Site, Aalborg

9301

Research Site, Bloemfontein

10003

Research Site, Cáceres

10029

Research Site, New York

10119

Research Site, Berlin

10459

Research Site, The Bronx

11215

Research Site, Brooklyn

11407

Research Site, Jerez de la Frontera

12157

Research Site, Berlin

13187

Research Site, Berlin

13210

Research Site, Syracuse

14059

Research Site, Berlin

15131

Research Site, Chancay

15683

Research Site, Scottdale

15905

Research Site, Johnstown

18300

Research Site, Loja (Granada)

19610

Research Site, Wyomissing

20110

Research Site, Manassas

20900

Research Site, Monza

21152

Research Site, Malmo

23552

Research Site, Lübeck

27100

Research Site, Pavia

27104

Research Site, Winston-Salem

28054

Research Site, Gastonia

28463

Research Site, Tabor City

28601

Research Site, Hickory

28602

Research Site, Hickory

28645

Research Site, Lenoir

29010

Research Site, Málaga

29118

Research Site, Orangeburg

29303

Research Site, Spartanburg

29340

Research Site, Gaffney

29341

Research Site, Gaffney

29603

Research Site, Marbella (Málaga)

29621

Research Site, Anderson

29631

Research Site, Benalmádena (Málaga)

29678

Research Site, Seneca

29720

Research Site, Lancaster

29732

Research Site, Rock Hill

30019

Research Site, Dacula

30033

Research Site, Decatur

30078

Research Site, Snellville

30281

Research Site, Stockbridge

30345

Research Site, Atlanta

32117

Research Site, Daytona Beach

32127

Research Site, Port Orange

32174

Research Site, Ormond Beach

32626

Research Site, Chiefland

32789

Research Site, Winter Park

32825

Research Site, Orlando

32952

Research Site, Merritt Island

33012

Research Site, Hialeah

33126

Research Site, Miami

33145

Research Site, Miami

33155

Research Site, Miami

33165

Research Site, Miami

33173

Research Site, Miami

33472

Research Site, Boynton Beach

33603

Research Site, Tampa

33607

Research Site, Tampa

33765

Research Site, Clearwater

33971

Research Site, Lehigh Acres

34239

Research Site, Sarasota

34741

Research Site, Kissimmee

34748

Research Site, Leesburg

35128

Research Site, Padua

35660

Research Site, Sheffield

35801

Research Site, Huntsville

36305

Research Site, Dothan

37045

Research Site, Legnago

37067

Research Site, Franklin

37167

Research Site, Smyrna

37909

Research Site, Knoxville

39770

Research Site, Laredo

41701

Research Site, Hazard

43080

Research Site, Durango

43207

Research Site, Columbus

43213

Research Site, Columbus

43302

Research Site, Marion

44100

Research Site, Guadalajara

44121

Research Site, Ferrara

44130

Research Site, Guadalajara

44200

Research Site, Guadalajara

44691

Research Site, Wooster

44718

Research Site, Canton

45242

Research Site, Cincinnati

45417

Research Site, Dayton

46112

Research Site, Brownsburg

46383

Research Site, Valparaiso

46520

Research Site, Sagunto(Valencia)

46600

Research Site, Alzira (Valencia)

47714

Research Site, Evansville

47838

Research Site, Riccione

47921

Research Site, Rimini

51069

Research Site, Cologne

52242

Research Site, Iowa City

53226

Research Site, Milwaukee

55905

Research Site, Rochester

60506

Research Site, Aurora

60596

Research Site, Frankfurt

60607

Research Site, Chicago

61602

Research Site, Peoria

63017

Research Site, Chesterfield

63110

Research Site, Rodgau-Dudenhofen

63122

Research Site, St Louis

63301

Research Site, Saint Charles

64128

Research Site, Kansas City

64460

Research Site, Monterrey

66061

Research Site, Olathe

66604

Research Site, Topeka

68510

Research Site, Lincoln

70006

Research Site, Metairie

70124

Research Site, Bari

70584

Research Site, Sunset

73034

Research Site, Edmond

75067

Research Site, Lewisville

75069

Research Site, McKinney

75070

Research Site, McKinney

75092

Research Site, Sherman

75093

Research Site, Plano

75234

Research Site, Dallas

75237

Research Site, Uppsala

75904

Research Site, Lufkin

76712

Research Site, Waco

77030

Research Site, Houston

77379

Research Site, Spring

77521

Research Site, Baytown

77640

Research Site, Port Arthur

78028

Research Site, Kerrville

78758

Research Site, Austin

79106

Research Site, Amarillo

80131

Research Site, Napoli

80246

Research Site, Denver

80301

Research Site, Boulder

83000

Research Site, Sonora

86001

Research Site, Flagstaff

86035

Research Site, Villahermosa

89506

Research Site, Reno

90822

Research Site, Long Beach

91786

Research Site, Upland

92103

Research Site, San Diego

92117

Research Site, San Diego

92120

Research Site, San Diego

92627

Research Site, Costa Mesa

92886

Research Site, Yorba Linda

94102

Research Site, Salt Lake City

94304

Research Site, Palo Alto

95123

Research Site, Catania

95648

Research Site, Lincoln

95670

Research Site, Gold River

96730

Research Site, Minatitlán

97220

Research Site, Portland

97504

Research Site, Medford

98055

Research Site, Renton

98208

Research Site, Everett

105077

Research Site, Moscow

191180

Research Site, StPetersburg

196601

Research Site, Saint Petersburg

197022

Research Site, Saint Petersburg

426035

Research Site, Izhevsk

432009

Research Site, Ulyanovsk

440067

Research Site, Penza

614000

Research Site, Perm

620039

Research Site, Yekaterinburg

630008

Research Site, Novosibirsk

630084

Research Site, Novosibirsk

644043

Research Site, Omsk

3341643

Research Site, Curicó

3465584

Research Site, Talca

4270918

Research Site, Talcahuano

8380453

Research Site, Santiago

8380456

Research Site, Santiago

90035074

Research Site, Porto Alegre

06716

Research Site, New Haven

04005

Research Site, Biddeford

08755

Research Site, Toms River

02864

Research Site, Cumberland

02914

Research Site, East Providence

02886

Research Site, Warwick

C1414AIF

Research Site, Buenos Aires

C1056ABJ

Research Site, CABA

C1425BEN

Research Site, CABA

Unknown

Research Site, CABA

Research Site, Cusco

Research Site, Piura

Research Site, Parow

C1440BRR

Research Site, Ciudad Autónoma de Buenos Aire

X5003DCE

Research Site, Córdoba

B7600FZN

Research Site, Mar del Plata

B7600GNY

Research Site, Mar del Plata

M5500GIP

Research Site, Mendoza

B6500EZL

Research Site, Nueve de Julio

S2000DEJ

Research Site, Rosario

A-8330

Research Site, Feldbach

04020

Research Site, Linz

18618-970

Research Site, Botucatu

90470-340

Research Site, Porto Alegre

90610-000

Research Site, Porto Alegre

91350-200

Research Site, Porto Alegre

09080-110

Research Site, Santo André

09750-420

Research Site, São Bernardo do Campo

01228-200

Research Site, São Paulo

04039-901

Research Site, São Paulo

18040-425

Research Site, Sorocaba

38411-186

Research Site, Uberlândia

29055-450

Research Site, Vitória

L1S 2J5

Research Site, Ajax

N8X 1T3

Research Site, Windsor

N8X 5A6

Research Site, Windsor

G1V 4G5

Research Site, Québec

G2J 0C4

Research Site, Québec

J6E 2B4

Research Site, Saint-Charles-Borromée

G8T 7A1

Research Site, Trois-Rivières

03044

Research Site, Cottbus

04357

Research Site, Leipzig

00100

Research Site, Roma

00168

Research Site, Roma

07100

Research Site, Sassari

N-3515

Research Site, Hønefoss

N-1671

Research Site, Kråkeroy

N-4005

Research Site, Stavanger

L18

Research Site, Lima

L27

Research Site, Lima

L41

Research Site, Lima

LIMA 1

Research Site, Lima

LIMA 21

Research Site, Lima

LIMA 31

Research Site, Lima

LIMA 32

Research Site, Lima

00717

Research Site, Ponce

00927

Research Site, San Juan

03114

Research Site, Alicante

07010

Research Site, Palma de Mallorca

08830

Research Site, Sant Boi de Llobregat

221 85

Research Site, Lund

222 21

Research Site, Lund

114 46

Research Site, Stockholm

BD9 6RJ

Research Site, Bradford

KT16 0PZ

Research Site, Chertsey

CH2 1UL

Research Site, Chester

DN2 5LT

Research Site, Doncaster

LA1 4RP

Research Site, Lancaster

S5 7AU

Research Site, Sheffield

ML2 0DP

Research Site, Wishaw

Sponsors
All Listed Sponsors
lead

Pearl Therapeutics, Inc.

INDUSTRY