Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo, in Patients With Asthma

PHASE3CompletedINTERVENTIONAL
Enrollment

475

Participants

Timeline

Start Date

July 31, 2006

Primary Completion Date

April 30, 2008

Study Completion Date

April 30, 2008

Conditions
Asthma
Interventions
DRUG

Fluticasone propionate/formoterol fumarate 100/10

FlutiForm 100/10ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.

DRUG

Fluticasone propionate 100

Fluticasone 100ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.

DRUG

Formoterol fumarate 10

Formoterol 10ug is a HFA pMDI that delivers 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.

DRUG

Placebo

Placebo is a HFA pMDI that delivers placebo aerosol. Patients will take 2 actuations BID for 12 weeks.

Trial Locations (57)

15241

Research Site, Pittsburgh

18509

Research Site, Scranton

19115

Research Site, Philadelphia

20814

Research Site, Bethesda

27909

Research Center, Elizabeth City

Research Site, Elizabeth City

28801

Research Site, Asheville

30012

Research Site, Conyers

32308

Research Site, Tallahassee

Research Site, Lawrenceville

32610

Research Site, Gainesville

33176

Research Site, Miami

33180

Research Site, Aventura

33770

Research Center, Largo

34471

Research Site, Ocala

35128

Research Site, Pell City

43235

Research Site, Columbus

43617

Research Site, Toledo

46208

Research Site, Indianapolis

60073

Research Site, Round Lake Beach

73104

Research Site, Oklahoma City

73112

Research Site, Oklahoma City

73139

Research Site, Okalahoma City

75069

Research Site, McKinney

75246

Research Site, Dallas

77024

Research Site, Houston

78229

Research Site, San Antonio

78681

Research Site, Round Rock

78750

Research Site, Austin

79925

Research Site, El Paso

80112

Research Site, Centennial

Research Site, Englewood

80907

Research Site, Colorado Springs

85251

Research Site, Scottsdale

90048

Research Center, Los Angeles

90630

Research Site, Cypress

91345

Research Site, Mission Hills

92024

Research Site, Encinitas

92708

Research Site, Fountain Valley

97035

Research Site, Lake Oswego

97401

Research Site, Eugene

97504

Research Site, Medford

98225

Research Site, Bellingham

06708

Research Site, Waterbury

02301

Research Site, Brockton

08003

Research Site, Cherry Hill

08732

Research Site, Forked River

L1S 2J5

Research Site, Ajax

P3A 1Y8

Research Site, Greater Sudbury

P3A1Y8

Research Site, Greater Sudbury

L5B 1N1

Research Site, Mississauga

K1Y 4G2

Research Site, Ottawa

N7V 1X4

Research Site, Point Edward

M5S 2A5

Research Site, Toronto

M6H 3M2

Research Site, Toronto

G6W 5M6

Research Site, Saint Romuald

A1B 4S8

Research Site, St. John's

All Listed Sponsors
lead

SkyePharma AG

INDUSTRY

NCT00393991 - Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo, in Patients With Asthma | Biotech Hunter | Biotech Hunter