A Study Comparing the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm™) With Fluticasone or Flovent to Treat Moderate to Severe Asthma in Adolescents and Adults

PHASE3CompletedINTERVENTIONAL
Enrollment

438

Participants

Timeline

Start Date

March 31, 2008

Primary Completion Date

October 31, 2008

Study Completion Date

October 31, 2008

Conditions
Asthma
Interventions
DRUG

FlutiForm 250/10

SKP FlutiForm 250/10ug is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.

DRUG

SKP-Fluticasone

SKP Fluticasone 250 ug is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.

DRUG

Flovent Fluticasone HFA

Flovent 250 ug HFA is a pMDI that delivers after priming 125ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.

Trial Locations (103)

13

Investigational Site, Lima

27

Investigational Site, Lima

29

Investigational Site, Lima

31

Investigational Site, Lima

32

Investigational Site, Lima

33

Investigational Site, Lima

1035

Investigational Site, Caba

1122

Investigational Site, Budapest

1525

Investigational Site, Budapest

2000

Investigational Site, Santa Fe

3526

Investigational Site, Miskolc

3529

Investigational Site, Miskolc

4000

Investigational Site, San Miguel de Tucumán

4126

Investigational Site, Durban

6772

Investigational Site, Deszk

7130

Investigational Site, Somerset West

7505

Investigational Site, Tygerberg

7530

Investigational Site, Cape Town

7621

Investigational Site, Pécs

7700

Investigational Site, Cape Town

9301

Investigational Site, Bloemfontein

14050

Investigational Site, Mexico City

21029

Investigational Site, Vinnytsia

23229

Investigational site, Richmond

27909

Investigational site, Elizabeth City

31238

Investigational Site, Chihuahua City

34677

Investigational Site, Oldsmar

39670

Investigational Site, Guerrero

41017

Investigational site, Crestview Hills

44100

Investigational Site, Jalisco

44313

Investigational Site, Akron

45200

Investigational Site, Jalisco

45227

Investigational site, Cincinnati

46208

Investigational Site, Indianapolis

49017

Investigational Site, Dnipropetrovsk

49026

Investigational Site, Dnipropetrovsk

49101

Investigational Site, Dnipropetrovsk

53227

Investigational Site, West Allis

58249

Investigational Site, Michoacán

61035

Investigational Site, Kharkiv

64460

Investigational Site, Nuevo León

69063

Investigational Site, Zaporizhzhya

69118

Investigational Site, Zaporizhzhya

70006

Investigational Site, Metarie

72190

Investigational Site, Puebla City

78750

Investigational Site, Austin

79010

Investigational Site, Lviv

79925

Investigational site, El Paso

83000

Investigational Site, Luis Encinas S/N

83017

Investigational Site, Donetsk

83099

Investigational Site, Donetsk

85251

Investigational site, Scottsdale

85282

Investigational Site, Tempe

86100

Investigational Site, Tabasco

90806

Investigational site, Long Beach

92024

Investigational Site, Encinitas

92869

Investigational site, Orange

97213

Investigational Site, Portland

200515

Investigational Site, Craiova

500326

Investigational Site, Brasov

9000002

Investigational Site, Palazu Mare

02747

Investigational site, North Dartmouth

02481

Investigational Site, Wellesley Hills

02914

Investigational Site, East Providence

02906

Investigational site, Providence

B8000JRB

Investigational Site, Bahía Blanca

B1704ESN

Investigational Site, Buenos Aires

C1122AAK

Investigational Site, Buenos Aires

Investigational Site, Caba

C1426ABO

Investigational Site, Buenos Aires

C1121ABE

Investigational Site, Caba

C1405BCH

Investigational Site, Caba

C1425AUA

Investigational Site, Caba

C1437HPA

Investigational Site, Caba

B6500BWQ

Investigational Site, Provincia de Buenos Aires

A4400ERH

Investigational Site, Salta

S2000JKR

Investigational Site, Santa Fe

Unknown

Investigational Site, Concepción

Investigational Site, Rancagua

Investigational Site, Santiago

Investigational Site, San Bernardino

Investigational Site, Cusco

Investigational Site, Jesus Maria

Investigational Site, Lima Cercado

Investigational Site, Lodz

Investigational Site, Rzeszów

Investigational Site, Timișoara

06700

Investigational Site, Mexico City

01

Investigational Site, Lima

80-847

Investigational Site, Gdansk

30-901

Investigational Site, Krakow

50-434

Investigational Site, Wroclaw

010457

Investigational Site, Bucharest

011172

Investigational Site, Bucharest

021381

Investigational Site, Bucharest

030303

Investigational Site, Bucharest

050042

Investigational Site, Bucharest

050554

Investigational Site, Bucharest

0157

Investigational Site, Pretoria

0181

Investigational Site, Pretoria

02125

Investigational Site, Kiev

02232

Investigational Site, Kiev

03680

Investigational Site, Kiev

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Abbott

INDUSTRY

collaborator

MDS Pharma Services

INDUSTRY

lead

SkyePharma AG

INDUSTRY

NCT00649025 - A Study Comparing the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm™) With Fluticasone or Flovent to Treat Moderate to Severe Asthma in Adolescents and Adults | Biotech Hunter | Biotech Hunter