A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® (Kronos)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,902

Participants

Timeline

Start Date

August 10, 2015

Primary Completion Date

January 5, 2018

Study Completion Date

January 5, 2018

Conditions
COPD
Interventions
DRUG

BGF MDI 320/14.4/9.6 μg

Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (PT010, BGF metered dose inhaler \[MDI\])

DRUG

GFF MDI (PT003) 14.4/9.6 μg

Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT003, GFF MDI)

DRUG

BFF MDI (PT009) 320/9.6 μg

Budesonide and Formoterol Fumarate Inhalation Aerosol (PT009, BFF MDI)

DRUG

Symbicort® Turbuhaler® (TBH) Inhalation Powder

Trial Locations (190)

14010

Research Site, Baotou

23225

Research Site, Richmond

23229

Research Site, Richmond

23606

Research Site, Newport News

24210

Research Site, Abingdon

26505

Research Site, Morgantown

27103

Research Site, Winston-Salem

27408

Research Site, Greensboro

28054

Research Site, Gastonia

28117

Research Site, Mooresville

28207

Research Site, Charlotte

28401

Research Site, Wilmington

28739

Research Site, Hendersonville

29303

Research Site, Spartanburg

29379

Research Site, Union

29406

Research Site, Charleston

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

30019

Research Site, Dacula

30071

Research Site, Norcross

31326

Research Site, Rincon

32174

Research Site, Ormond Beach

32503

Research Site, Pensacola

32789

Research Site, Winter Park

33175

Research Site, Miami

33186

Research Site, Miami

33321

Research Site, Tamarac

33603

Research Site, Tampa

33756

Research Site, Clearwater

35501

Research Site, Jasper

36420

Research Site, Andalusia

37601

Research Site, Johnson City

43016

Research Site, Dublin

43213

Research Site, Columbus

43235

Research Site, Columbus

45231

Research Site, Cincinnati

45242

Research Site, Cincinnati

45245

Research Site, Cincinnati

45459

Research Site, Dayton

55125

Research Site, Woodbury

55402

Research Site, Minneapolis

55407

Research Site, Minneapolis

55435

Research Site, Edina

63141

Research Site, St Louis

63301

Research Site, Saint Charles

75605

Research Site, Longview

77339

Research Site, Kingwood

78229

Research Site, San Antonio

85018

Research Site, Phoenix

85381

Research Site, Peoria

87108

Research Site, Albuquerque

89503

Research Site, Reno

90274

Research Site, Rolling Hills Estates

92064

Research Site, Poway

92835

Research Site, Fullerton

95670

Research Site, Gold River

95821

Research Site, Sacramento

97504

Research Site, Medford

98405

Research Site, Tacoma

100048

Research Site, Beijing

100730

Research Site, Beijing

100853

Research Site, Beijing

110001

Research Site, Shenyang

110004

Research Site, Shengyang

110016

Research Site, Shenyang

130021

Research Site, Changchun

200092

Research Site, Shanghai

200120

Research Site, Shanghai

200240

Research Site, Shanghai

200433

Research Site, Shanghai

221006

Research Site, Xuzhou

225012

Research Site, Yangzhou

246003

Research Site, Anqing

250013

Research Site, Jinan

300052

Research Site, Tianjin

310014

Research Site, Hangzhou

317000

Research Site, Linhai

320204

Research Site, Wuxi

325027

Research Site, Wenzhou

330006

Research Site, Nanchang

337055

Research Site, Pingxiang

410002

Research Site, Changsha

410011

Research Site, Changsha

413000

Research Site, Heshan

430022

Research Site, Wuhan

510000

Research Site, Guangzhou

510120

Research Site, Guangzhou

510150

Research Site, Guangzhou

510180

Research Site, Guangzhou

519099

Research Site, Zhuhai

570311

Research Site, Haikou

830054

Research Site, Ürümqi

B2N 1L2

Research Site, Truro

P3A 1W8

Research Site, Greater Sudbury

L4V 1P1

Research Site, Mississauga

M3J 2C5

Research Site, Toronto

J7J 2K8

Research Site, Mirabel

H1M 1B1

Research Site, Montreal

G1V 4G5

Research Site, Québec

G8T 7A1

Research Site, Trois-Rivières

G1W 4R4

Research Site, Québec

CN-100029

Research Site, Beijing

010017

Research Site, Hohhot

010050

Research Site, Hohhot

222 002

Research Site, Lianyungang

030001

Research Site, Taiyuan

113-8431

Research Site, Bunkyō City

103-0022

Research Site, Chūōku

103-0027

Research Site, Chūōku

104-8560

Research Site, Chūōku

969-1793

Research Site, Date-gun

814-0180

Research Site, Fukuoka

901-2214

Research Site, Ginowan-shi

812-0033

Research Site, Hakata-shi

430-0906

Research Site, Hamamatsu

430-8525

Research Site, Hamamatsu

434-8511

Research Site, Hamamatsu

992-0601

Research Site, Higashiokitama-gun

577-0843

Research Site, Higashiosaka-shi

672-8064

Research Site, Himeji-shi

573-1191

Research Site, Hirakata-shi

820-8505

Research Site, Iizuka-shi

173-8610

Research Site, Itabashi-ku

438-8550

Research Site, Iwata-shi

693-0068

Research Site, Izumo-shi

693-8501

Research Site, Izumo-shi

892-0847

Research Site, Kagoshima

920-0293

Research Site, Kahoku-gun

675-0023

Research Site, Kakogawa-shi

714-0081

Research Site, Kasaoka-shi

816-0813

Research Site, Kasuga-shi

596-8501

Research Site, Kishiwada-shi

204-0023

Research Site, Kiyose-shi

650-0017

Research Site, Kobe

811-3195

Research Site, Koga-shi

711-0921

Research Site, Kurashiki-shi

737-0193

Research Site, Kure-shi

737-8505

Research Site, Kure-shi

601-1434

Research Site, Kyoto

601-8206

Research Site, Kyoto

602-8026

Research Site, Kyoto

607-8062

Research Site, Kyoto

615-8087

Research Site, Kyoto

371-0054

Research Site, Maebashi

390-0872

Research Site, Matsumoto-shi

515-8544

Research Site, Matsusaka-shi

153-8515

Research Site, Meguro-ku

181-8611

Research Site, Mitaka-shi

509-6134

Research Site, Mizunami-shi

940-2085

Research Site, Nagaoka-shi

454-8502

Research Site, Nagoya

457-8511

Research Site, Nagoya

466-8560

Research Site, Nagoya

902-0061

Research Site, Naha

969-0213

Research Site, Nishishirakawa-gun

080-0013

Research Site, Obihiro-shi

503-8502

Research Site, Ogaki-shi

904-2143

Research Site, Okinawa-shi

831-0016

Research Site, Ookawa-shi

543-0035

Research Site, Osaka

589-8511

Research Site, Osakasayama-shi

870-0921

Research Site, Ōita

870-0951

Research Site, Ōita

520-0804

Research Site, Ōtsu

762-8550

Research Site, Sakaide-shi

591-8555

Research Site, Sakaishi

001-0901

Research Site, Sapporo

064-0915

Research Site, Sapporo

980-8574

Research Site, Sendai

983-0824

Research Site, Sendai

984-8560

Research Site, Sendai

489-8642

Research Site, Seto-shi

142-8666

Research Site, Shinagawa-ku

162-0052

Research Site, Shinjuku-ku

420-8630

Research Site, Shizuoka

564-0013

Research Site, Suita-shi

190-0014

Research Site, Tachikawa-shi

760-8538

Research Site, Takamatsu

791-0281

Research Site, Toon-shi

171-0014

Research Site, Toshima-ku

930-0194

Research Site, Toyama

931-8533

Research Site, Toyama

939-8282

Research Site, Toyama

832-0059

Research Site, Yanagawa-shi

236-0004

Research Site, Yokohama

Sponsors
All Listed Sponsors
lead

Pearl Therapeutics, Inc.

INDUSTRY