Study to Assess Efficacy and Safety of PT009 Compared to PT005, PT008, and Symbicort® Turbuhaler® on Lung Function Over 24-Weeks in Subjects With Moderate to Very Severe COPD

PHASE3CompletedINTERVENTIONAL
Enrollment

2,389

Participants

Timeline

Start Date

May 31, 2016

Primary Completion Date

December 1, 2017

Study Completion Date

December 1, 2017

Conditions
Chronic Obstructive Pulmonary Disorder
Interventions
DRUG

BFF MDI 320/9.6 μg

Blinded Treatment

DRUG

BFF MDI 160/9.6 μg

Blinded Treatment

DRUG

FF MDI 9.6 μg

Blinded Treatment

DRUG

BD MDI 320 μg

Blinded Treatment

DRUG

Symbicort® TBH 400/12 μg BID

Open Label

Trial Locations (259)

1135

Research Site, Budapest

2100

Research Site, Gödöllő

2440

Research Site, Százhalombatta

2660

Research Site, Balassagyarmat

2700

Research Site, Cegléd

2900

Research Site, Komárom

3000

Research Site, Hatvan

3529

Research Site, Miskolc

4080

Research Site, Hajdúnánás

4400

Research Site, Nyíregyháza

5000

Research Site, Szolnok

6900

Research Site, Makó

7626

Research Site, Pécs

7635

Research Site, Pécs

8600

Research Site, Siófok

9300

Research Site, Csorna

10119

Research Site, Berlin

10629

Research Site, Berlin

10787

Research Site, Berlin

10803

Research Site, Larchmont

11236

Research Site, Jackson Heights

12157

Research Site, Berlin

13156

Research Site, Berlin

13620

Research Site, Seongnam-si

14059

Research Site, Berlin

14068

Research Site, Anyang-si

15000

Research Site, Prague

15236

Research Site, Pittsburgh

15243

Research Site, Pittsburgh

16900

Research Site, Prague

19055

Research Site, Schwerin

20253

Research Site, Hamburg

20354

Research Site, Hamburg

21157

Research Site, Westminster

21204

Research Site, Towson

21431

Research Site, Incheon

23294

Research Site, Richmond

23552

Research Site, Lübeck

23606

Research Site, Newport News

27103

Research Site, Winston-Salem

27408

Research Site, Greensboro

28054

Research Site, Gastonia

28078

Research Site, Huntersville

28207

Research Site, Charlotte

29303

Research Site, Spartanburg

29341

Research Site, Gaffney

29379

Research Site, Union

29464

Research Site, Mt. Pleasant

29615

Research Site, Greenville

29621

Research Site, Anderson

29640

Research Site, Easley

29678

Research Site, Seneca

29707

Research Site, Old Point Station

29732

Research Site, Rock Hill

30513

Research Site, Blue Ridge

32127

Research Site, Port Orange

32129

Research Site, Port Orange

32405

Research Site, Panama City

32720

Research Site, DeLand

33016

Research Site, Hialeah

33134

Research Site, Miami

33175

Research Site, Miami

33186

Research Site, Miami

33603

Research Site, Tampa

33756

Research Site, Clearwater

33765

Research Site, Clearwater

35243

Research Site, Birmingham

35611

Research Site, Athens

36305

Research Site, Dothan

37601

Research Site, Johnson City

37660

Research Site, Kingsport

37701

Research Site, Jindřichův Hradec

38601

Research Site, Strakonice

43016

Research Site, Dublin

43123

Research Site, Grove City

43213

Research Site, Columbus

43215

Research Site, Columbus

43801

Research Site, Žatec

45355

Research Site, Essen

45459

Research Site, Dayton

48336

Research Site, Farmington Hills

49201

Research Site, Busan

51069

Research Site, Cologne

54907

Research Site, Jeonju

55125

Research Site, Woodbury

55407

Research Site, Minneapolis

55432

Research Site, Fridley

55435

Research Site, Edina

58103

Research Site, Fargo

60596

Research Site, Frankfurt

63110

Research Site, Rodgau-Dudenhofen

63141

Research Site, St Louis

63301

Research Site, Saint Charles

64283

Research Site, Darmstadt

73103

Research Site, Oklahoma City

77479

Research Site, Sugar Land

77530

Research Site, Channelview

78130

Research Site, New Braunfels

78212

Research Site, San Antonio

78229

Research Site, San Antonio

78233

Research Site, Live Oak

80127

Research Site, Littleton

80301

Research Site, Boulder

80907

Research Site, Colorado Springs

83646

Research Site, Meridian

85006

Research Site, Phoenix

85020

Research Site, Phoenix

85745

Research Site, Tucson

89014

Research Site, Henderson

89052

Research Site, Henderson

89118

Research Site, Las Vegas

92120

Research Site, San Diego

92262

Research Site, Palm Springs

92801

Research Site, Anaheim

95670

Research Site, Gold River

95823

Research Site, Sacramento

96049

Research Site, Bamberg

97504

Research Site, Medford

98004

Research Site, Bellevue

98007

Research Site, Bellevue

98405

Research Site, Tacoma

119991

Research Site, Moscow

123423

Research Site, Moscow

123995

Research Site, Moscow

125315

Research Site, Moscow

129090

Research Site, Moscow

150002

Research Site, Yaroslavl

150062

Research Site, Yaroslavl

153005

Research Site, Ivanovo

193231

Research Site, Saint Petersburg

194044

Research Site, Saint Petersburg

194291

Research Site, Saint Petersburg

194354

Research Site, Saint Petersburg

196084

Research Site, Saint Petersburg

196143

Research Site, Saint Petersburg

196247

Research Site, Saint Petersburg

196601

Research Site, Saint Petersburg

197022

Research Site, Saint Petersburg

197089

Research Site, Saint Petersburg

197342

Research Site, Saint Petersburg

198260

Research Site, Saint Petersburg

214006

Research Site, Smolensk

214019

Research Site, Smolensk

344068

Research Site, Rostov-on-Don

357538

Research Site, Pytigorsk

390026

Research Site, Ryazan

394066

Research Site, Voronezh

410012

Research Site, Saratov

420008

Research Site, Kazan'

420012

Research Site, Kazan'

426035

Research Site, Izhevsk

432009

Research Site, Ulyanovsk

440026

Research Site, Penza

440067

Research Site, Penza

454106

Research Site, Chelyabinsk

525947

Research Site, Liberec

600023

Research Site, Vladimir

603126

Research Site, Nizhny Novgorod

610027

Research Site, Kirov

614000

Research Site, Perm

620039

Research Site, Yekaterinburg

620149

Research Site, Yekaterinburg

630008

Research Site, Novosibirsk

630051

Research Site, Novosibirsk

630084

Research Site, Novosibirsk

630087

Research Site, Novosibirsk

644043

Research Site, Omsk

644112

Research Site, Omsk

656045

Research Site, Barnaul

06517

Research Site, Hamden

32789-4681

Research Site, Winter Park

02747

Research Site, North Dartmouth

05403

Research Site, South Burlington

T6L 5X8

Research Site, Edmonton

R2K 3S8

Research Site, Winnipeg

B2N 1L2

Research Site, Truro

L1S 2J5

Research Site, Ajax

L7M 4Y1

Research Site, Burlington

P3A 1W8

Research Site, Greater Sudbury

M3J 2C5

Research Site, Toronto

N8X 1T3

Research Site, Windsor

N8X 5A6

Research Site, Windsor

J7J 2K8

Research Site, Mirabel

H1M 1B1

Research Site, Montreal

H9R 3J1

Research Site, Pointe-Claire

G1G 3Y8

Research Site, Québec

G1V 4G5

Research Site, Québec

G3K 2P8

Research Site, Québec

J6E 2B4

Research Site, Saint-Charles-Borromée

G8T 7A1

Research Site, Trois-Rivières

G6P 6P6

Research Site, Victoriaville

S7N 0W8

Research Site, Saskatoon

G1W 4R4

Research Site, Québec

680 01

Research Site, Boskovice

250 01

Research Site, Brandýs nad Labem

410 02

Research Site, Lovosice

473 01

Research Site, Nový Bor

700 30

Research Site, Ostrava-Hrabuvka

708 68

Research Site, Ostrava-Poruba

140 00

Research Site, Prague

140 59

Research Site, Prague

190 00

Research Site, Prague

337 22

Research Site, Rokycany

415 01

Research Site, Teplice

407 47

Research Site, Varnsdorf

04109

Research Site, Leipzig

04207

Research Site, Leipzig

H-6722

Research Site, Szeged

15-003

Research Site, Bialystok

15-044

Research Site, Bialystok

15-430

Research Site, Bialystok

43-300

Research Site, Bielsko-Biala

22-100

Research Site, Chełm

82-300

Research Site, Elblag

80-952

Research Site, Gdansk

86-300

Research Site, Grudziądz

40-648

Research Site, Katowice

64-000

Research Site, Kościan

30-901

Research Site, Krakow

31-159

Research Site, Krakow

59-220

Research Site, Legnica

90-141

Research Site, Lodz

91-363

Research Site, Lodz

20-093

Research Site, Lublin

09-505

Research Site, Nowy Duninów

27-400

Research Site, Ostrowiec Świętokrzyski

63-400

Research Site, Ostrów Wielkopolski

41-94O

Research Site, Piekary Śląskie

64-920

Research Site, Piła

60-685

Research Site, Poznan

60-693

Research Site, Poznan

60-823

Research Site, Poznan

32-100

Research Site, Proszowice

24-100

Research Site, Puławy

41-709

Research Site, Ruda Śląska

35-051

Research Site, Rzeszów

35-205

Research Site, Rzeszów

08-110

Research Site, Siedlce

96-500

Research Site, Sochaczew

16-400

Research Site, Suwałki

70-111

Research Site, Szczecin

33-100

Research Site, Tarnów

55-100

Research Site, Trzebnica

01-518

Research Site, Warsaw

02-777

Research Site, Warsaw

98-300

Research Site, Wieluń

05-200

Research Site, Wołomin

53-301

Research Site, Wroclaw

41-800

Research Site, Zabrze

22-400

Research Site, Zamość

02559

Research Site, Seoul

02841

Research Site, Seoul

03080

Research Site, Seoul

03181

Research Site, Seoul

03722

Research Site, Seoul

04401

Research Site, Seoul

04551

Research Site, Seoul

06591

Research Site, Seoul

08308

Research Site, Seoul

Sponsors
All Listed Sponsors
lead

Pearl Therapeutics, Inc.

INDUSTRY