New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo in Patients With Moderate to Severe Asthma

PHASE3CompletedINTERVENTIONAL
Enrollment

557

Participants

Timeline

Start Date

June 30, 2006

Primary Completion Date

April 30, 2008

Study Completion Date

April 30, 2008

Conditions
Asthma
Interventions
DRUG

Fluticasone propionate/Formoterol fumarate 250/10

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

Placebo

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

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 250

Fluticasone 250 is a HFA pMDI that delivers 125ug 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.

Trial Locations (63)

11570

Research Site, Rockville Centre

19013

Research Center, Upland

21236

Research Site, Baltimore

23225

Research Site, Richmond

29607

Research Site, Greenville

29621

Research Center, Anderson

30012

Research Center, Congers

31406

Research Site, Savannah

32174

Research Site, Ormond Beach

32405

Research Center, Panama City

32503

Research Site, Pensacola

32605

Research Center, Gainesville

33013

Research Site, Hialeah

33613

Research Site, Tampa

35128

Research Center, Pell City

40215

Research Site, Louisville

53209

Research Site, Milwaukee

55402

Research Center, Minneapolis

Research Site, Minneapolis

55441

Research Site, Plymouth

59718

Research Site, Bozeman

60073

Research Site, Round Lake Beach

63141

Research Site, St Louis

68130

Research Site, Omaha

72205

Research Site, Little Rock

Research Site, San Antonio

72401

Research Site, Jonesboro

73139

Research Site, Oklahoma City

75231

Research Site, Dallas

76104

Research Center, Fort Worth

78229

Research Site, San Antonio

78750

Research Site, Austin

79902

Research Site, El Paso

85050

Research Center, Phoenix

Research Site, Phoenix

85306

Research Site, Glendale

85712

Research Site, Tucson

89123

Research Site, Las Vegas

90025

Research Site, Los Angeles

90048

Research Center, Los Angeles

Research Site, Los Angeles

90806

Research Site, Long Beach

91505

Research Site, Burbank

91754

Research Site, Monterey Park

92120

Research Site, San Diego

92123

Research Site, San Diego

92691

Research Site, Mission Viejo

93551

Research Site, Palmdale

93720

Research Site, Fresno

95128

Research Site, San Jose

95819

Research Site, Sacramento

97213

Research Center, Portland

97504

Research Site, Medford

97520

Research Site, Ashland

98405

Research Site, Tacoma

02747

Research Site, North Dartmouth

02780

Research Site, Taunton

08724

Research Site, Brick

08054

Research Site, Mount Laurel

08558

Research Site, Skillman

07001

Research Site, Tinton Falls

02865

Research Site, Lincoln

00733

Research Center, Ponce

All Listed Sponsors
lead

SkyePharma AG

INDUSTRY

NCT00393952 - New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo in Patients With Moderate to Severe Asthma | Biotech Hunter | Biotech Hunter