A Phase I Study in Asthma Patients Evaluating the Effect of Doses of FlutiForm™ on the Amount, if Any, of Cortisol Produced by the Adrenal Glands

PHASE1CompletedINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

April 30, 2008

Primary Completion Date

September 30, 2008

Study Completion Date

September 30, 2008

Conditions
Asthma
Interventions
DRUG

FlutiForm 250/10 ug

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 6 weeks.

DRUG

FlutiForm 100/10 ug

SKP 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 6 weeks.

DRUG

Oral Prednisone 10mg

2 x 5 mg oral prednisone tablets, over encapsulated, once a day for one week.

DRUG

Placebo

2 x 5 mg placebo tablets, over encapsulated, once a day for six weeks. SKP FlutiForm placebo HFA pMDI. Two actuations BID for six weeks.

Trial Locations (19)

21122

Investigational Site, Pasadena

29303

Investigational site, Spartanburg

32720

Investigational site, DeLand

68154

Investigational site, Omaha

78130

Investigational site, New Braunfels

78229

Investigational site, San Antonio

79902

Investigational site, El Paso

80112

Investigational site, Centennial

80206

Investigational site, Denver

80401

Investigational site, Lakewood

80907

Investigational site, Colorado Springs

85006

Investigational site, Phoenix

90806

Investigational site, Long Beach

92120

Investigational site, San Diego

92801

Investigational site, Anaheim

97035

Investigational Site, Lake Oswego

97213

Investigational site, Portland

02747

Investigational site, North Dartmouth

08558

Investigational site, Skillman

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Abbott

INDUSTRY

lead

SkyePharma AG

INDUSTRY

NCT00657774 - A Phase I Study in Asthma Patients Evaluating the Effect of Doses of FlutiForm™ on the Amount, if Any, of Cortisol Produced by the Adrenal Glands | Biotech Hunter | Biotech Hunter