Efficacy and Safety Evaluation of Budesonide/Formoterol SPIROMAX® Inhalation Powder Versus SYMBICORT® TURBOHALER®

PHASE3CompletedINTERVENTIONAL
Enrollment

605

Participants

Timeline

Start Date

July 4, 2013

Primary Completion Date

March 20, 2014

Study Completion Date

March 20, 2014

Conditions
Asthma
Interventions
DRUG

Budesonide/Formoterol SPIROMAX®

BF Spiromax will be administered per dose and schedule specified in the arm.

DRUG

SYMBICORT® TURBOHALER®

Symbicort Turbohaler will be administered per dose and schedule specified in the arm.

DRUG

SYMBICORT placebo

SYMBICORT placebo multi-dose dry powder inhaler (DPI) identical in appearance to SYMBICORT TURBOHALER will be administered per dose and schedule specified in the arm.

DRUG

SPIROMAX Placebo

SPIROMAX Placebo multi-dose dry powder inhaler (DPI) identical in appearance to BF SPIROMAX will be administered per dose and schedule specified in the arm.

Trial Locations (114)

1134

Teva Investigational Site 51072, Budapest

2045

Teva Investigational Site 51074, Törökbálint

2310

Teva Investigational Site 51067, Budapest

2400

Teva Investigational Site 39020, Copenhagen NV

2660

Teva Investigational Site 51075, Balassagyarmat

2800

Teva Investigational Site 51076, Tatabánya

2900

Teva Investigational Site 51068, Komárom

3545

Teva Investigational Site 37031, Halen

4020

Teva Investigational Site 33019, Linz

4357

Teva Investigational Site 32246, Leipzig

4600

Teva Investigational Site 33018, Wels

4710

Teva Investigational Site 33020, Grieskirchen

5000

Teva Investigational Site 39021, Odense

5100

Teva Investigational Site 37030, Jambes

6534

Teva Investigational Site 37029, Gozée

6772

Teva Investigational Site 51065, Deszk

7257

Teva Investigational Site 51070, Mosdós

7400

Teva Investigational Site 51071, Kaposvár

Teva Investigational Site 51073, Kaposvár

9300

Teva Investigational Site 51077, Csorna

10367

Teva Investigational Site 32243, Berlin

10717

Teva Investigational Site 32255, Berlin

10787

Teva Investigational Site 32256, Berlin

12043

Teva Investigational Site 32244, Neukölln

12687

Teva Investigational Site 32257, Berlin

15562

Teva Investigational Site 32241, Rudersdorf

18101

Teva Investigational Site 80036, Afula

20100

Teva Investigational Site 40003, Turku

20142

Teva Investigational Site 30056, Milan

20354

Teva Investigational Site 32249, Hamburg

22927

Teva Investigational Site 32259, Großhansdorf

23858

Teva Investigational Site 32250, Reinfeld

27711

Teva Investigational Site 54068, Neratovice

28006

Teva Investigational Site 31058, Madrid

28500

Teva Investigational Site 40002, Pori

28922

Teva Investigational Site 31051, Alcorcón

29609

Teva Investigational Site 35088, Brest

31008

Teva Investigational Site 31056, Pamplona

31096

Teva Investigational Site 80035, Haifa

33521

Teva Investigational Site 40001, Tampere

35122

Teva Investigational Site 30054, Padua

35340

Teva Investigational Site 35089, La Bouëxière

40100

Teva Investigational Site 40005, Jyväskylä

41013

Teva Investigational Site 31055, Seville

44200

Teva Investigational Site 35090, Nantes

44281

Teva Investigational Site 80040, Kfar Saba

45879

Teva Investigational Site 32254, Gelsenkirchen

48013

Teva Investigational Site 31053, Bilbao

49100

Teva Investigational Site 80039, Petah Tikva

49610

Teva Investigational Site 35092, Mûrs-Erigné

56124

Teva Investigational Site 30055, Cisanello Pisa

60318

Teva Investigational Site 32251, Frankfurt am Main

60389

Teva Investigational Site 32253, Frankfurt am Main

63071

Teva Investigational Site 32258, Offenbach

63263

Teva Investigational Site 32240, Neu-Isenburg

66000

Teva Investigational Site 35091, Perpignan

69317

Teva Investigational Site 35093, Lyon

69469

Teva Investigational Site 32247, Weinheim

70300

Teva Investigational Site 80041, Ẕerifin

76100

Teva Investigational Site 80038, Rehovot

125367

Teva Investigational Site 50177, Moscow

150003

Teva Investigational Site 50174, Yaroslavl

188640

Teva Investigational Site 50170, Vsevolozhsk

193231

Teva Investigational Site 50178, Saint Petersburg

194354

Teva Investigational Site 50175, Saint Petersburg

197022

Teva Investigational Site 50171, Saint Petersburg

410028

Teva Investigational Site 50172, Saratov

420015

Teva Investigational Site 50179, Kazan'

634050

Teva Investigational Site 50173, Tomsk

5262160

Teva Investigational Site 80037, Ramat Gan

602 00

Teva Investigational Site 54056, Brno

500 05

Teva Investigational Site 54061, Hradec Králové

709 00

Teva Investigational Site 54063, Ostrava - Marianske Hory

301 00

Teva Investigational Site 54065, Pilsen

142 00

Teva Investigational Site 54067, Prague

186 00

Teva Investigational Site 54058, Prague

337 22

Teva Investigational Site 54064, Rokycany

386 01

Teva Investigational Site 54059, Strakonice

00290

Teva Investigational Site 40004, Helsinki

03050

Teva Investigational Site 32252, Cottbus

1815 JD

Teva Investigational Site 38048, Alkmaar

8901 BR

Teva Investigational Site 38049, Leeuwarden

15-276

Teva Investigational Site 53114, Bialystok

15-430

Teva Investigational Site 53110, Bialystok

80-433

Teva Investigational Site 53117, Gdansk

80-847

Teva Investigational Site 53106, Gdansk

31-011

Teva Investigational Site 53109, Krakow

31-023

Teva Investigational Site 53111, Krakow

31-159

Teva Investigational Site 53100, Krakow

90-153

Teva Investigational Site 53107, Lodz

20-093

Teva Investigational Site 53102, Lublin

60-214

Teva Investigational Site 53116, Poznan

81-741

Teva Investigational Site 53119, Sopot

47-100

Teva Investigational Site 53103, Strzelce Opolskie

71-124

Teva Investigational Site 53104, Szczecin

33-100

Teva Investigational Site 53105, Tarnów

51-343

Teva Investigational Site 53120, Wroclaw

53-201

Teva Investigational Site 53099, Wroclaw

53-301

Teva Investigational Site 53115, Wroclaw

41-800

Teva Investigational Site 53113, Zabrze

95-100

Teva Investigational Site 53101, Zgierz

08916

Teva Investigational Site 31054, Badalona

08036

Teva Investigational Site 31052, Barcelona

08041

Teva Investigational Site 31057, Barcelona

01004

Teva Investigational Site 31061, Vitoria-Gasteiz

413 45

Teva Investigational Site 42014, Gothenburg

222 41

Teva Investigational Site 42011, Lund

141 86

Teva Investigational Site 42012, Stockholm

S40 4AA

Teva Investigational Site 34024, Chesterfield

CV6 4DD

Teva Investigational Site 34026, Coventry

DD1 4HJ

Teva Investigational Site 34022, Dundee

TN40 1JJ

Teva Investigational Site 34027, East Sussex

FY4 3AD

Teva Investigational Site 34029, Lancashire

EC1M 6BQ

Teva Investigational Site 34028, London

All Listed Sponsors
lead

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

NCT01803555 - Efficacy and Safety Evaluation of Budesonide/Formoterol SPIROMAX® Inhalation Powder Versus SYMBICORT® TURBOHALER® | Biotech Hunter | Biotech Hunter