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FlutiForm 250

Phase 1

Asthma | Small molecule | Respiratory |Pacira BioSciences, Inc.|Trials Updated: Dec 1, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment160

FDA Designations

No designations recorded

FlutiForm 250 clinical trials

FlutiForm 250 · 1 trial · 1 indication

Phase 1 1
NCT00657774A Phase I Study in Asthma Patients Evaluating the Effect of Doses of FlutiForm™ on the Amount, if Any, of Cortisol Produced by the Adrenal GlandsAsthma
COMPLETED160 Analytics
PHASE1COMPLETED
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
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Investigate effect of SKP FlutiForm 250/10 ug HFA pMDI BID for 6 weeks, FlutiForm 100/10 ug HFA pMDI BID, 10 mg prednisone for 7 days, compared to Placebo on the hypothalamic-pituitary-adrenal (HPA) axis using measurement of 24-hours UFC
Baseline and Study days 42-43

Secondary Endpoints

To assess the safety profile of SKP FlutiForm HFA pMDI using incidence of adverse events (AEs) and changes in electrocardiograms (ECGs), vital signs and clinical laboratory tests.
From Baseline up to 2 weeks after last dosing
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALFlutiForm 250/10 ug
2EXPERIMENTALFlutiForm 100/10 ug
3ACTIVE_COMPARATOROral Prednisone 10 mg
4PLACEBO_COMPARATORPlacebo inhaler and/or placebo tablets

Interventions

NameTypeDescription
FlutiForm 250/10 ugDRUGSKP 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.
FlutiForm 100/10 ugDRUGSKP 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.
Oral Prednisone 10mgDRUG2 x 5 mg oral prednisone tablets, over encapsulated, once a day for one week.
PlaceboDRUG2 x 5 mg placebo tablets, over encapsulated, once a day for six weeks. SKP FlutiForm placebo HFA pMDI. Two actuations BID for six weeks.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Age 18-65 at the Screening Visit; * History of asthma for at least 6 months prior to Screening Visit * Well controlled asthma with rescue short acting beta agonist (albuterol) and or stable doses of other medications for at least 4 weeks prior to Screening Visit * Female subje...

Countries:United States
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Frequently asked questions about FlutiForm 250

What is FlutiForm 250 used for?

FlutiForm 250 is an investigational inhaled therapy being studied for the treatment of asthma. It is a small molecule product developed by Pacira BioSciences, Inc. and has been evaluated in a Phase 1 clinical trial in adult asthma patients. It is not approved for commercial use.

Who makes FlutiForm 250?

FlutiForm 250 is being developed by Pacira BioSciences, Inc., which trades on the Nasdaq under the ticker PCRX. The company sponsored the Phase 1 asthma study of the product.

What phase is FlutiForm 250 in?

FlutiForm 250 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The product remains investigational and has not been approved by the FDA for any indication.

What clinical trials is FlutiForm 250 in?

FlutiForm 250 has been studied in one completed Phase 1 trial, NCT00657774. That randomized, double-blind, placebo-controlled study enrolled 160 adults with asthma in the United States and evaluated the effect of FlutiForm doses on cortisol produced by the adrenal glands.