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FlutiForm 250/10

Phase 3

Asthma | Small molecule | Respiratory |Abbott Laboratories|Last Updated: Aug 27, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment438

FDA Designations

No designations recorded

Clinical trial landscape

FlutiForm 250/10 · 1 trial · 1 indication

Phase 3 1
NCT00649025A 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 AdultsAsthma
COMPLETED438 Analytics
PHASE3COMPLETED
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
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

To demonstrate the efficacy in terms of the Formoterol fumarate component of SKP FlutiForm HFA pMDI (250/10ug) compared to SKP Fluticasone HFA pMDI (250ug), on the change in FEV1 from morning pre-dose at Baseline (Week 0) to 2 hours post-dose at Week 12.
Week 0 and 12 visits

Secondary Endpoints

Demonstrate the efficacy of SKP FLUTIFORM HFA pMDI (250/10ug) compared to FLOVENT® Fluticasone pMDI (250ug) on the change in FEV1 from morning pre-dose at Baseline (Week 0) to 2 hours post-dose at Week 12.
Week 0 and 12 visits
Demonstrate the efficacy of SKP FLUTIFORM HFA pMDI (250/10ug) using other pulmonary function tests (PFTs), and clinical endpoints.
Whole duration of study
Assess the safety profile of SKP FLUTIFORM HFA pMDI (250/10ug twice daily) using incidence of adverse events, and changes in electrocardiograms, clinical laboratory tests and vital signs.
Whole duration of study
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALFlutiForm 250/10ug
2ACTIVE_COMPARATORSKP Fluticasone 250ug
3ACTIVE_COMPARATORFlovent Fluticasone HFA

Interventions

NameTypeDescription
FlutiForm 250/10DRUGSKP 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.
SKP-FluticasoneDRUGSKP Fluticasone 250 ug is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.
Flovent Fluticasone HFADRUGFlovent 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.
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites103

Main Inclusion Criteria: * ≥ Age 12 years at the Screening Visit. * History of asthma for 12 months prior to the Screening Visit. * Documented use of an inhaled corticosteroid for at least 4 weeks prior to the Screening Visit. * Steroid-requiring patient * patients must demonstrate (1) an FEV1 of 4...

Countries:United StatesArgentinaChileHungaryMexicoPeruPolandRomaniaSouth AfricaUkraine
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Frequently asked questions about FlutiForm 250/10

What is FlutiForm 250/10 used for?

FlutiForm 250/10 is an investigational small molecule being developed for the treatment of asthma. It is a combination product containing fluticasone and formoterol, intended for use in adolescents and adults with moderate to severe asthma. The drug is currently in Phase 3 clinical development.

What does FlutiForm 250/10 target?

FlutiForm 250/10 combines fluticasone, a corticosteroid, and formoterol, a long-acting beta-agonist. Fluticasone reduces airway inflammation, while formoterol relaxes bronchial smooth muscle to improve airflow. This dual mechanism addresses both the inflammatory and bronchoconstrictive components of asthma.

Who makes FlutiForm 250/10?

FlutiForm 250/10 is being developed by Abbott Laboratories, a company publicly traded under the ticker symbol ABT. The drug is currently in Phase 3 clinical development for the treatment of asthma.

What phase is FlutiForm 250/10 in?

FlutiForm 250/10 is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 clinical trial has been completed to evaluate its safety and efficacy in patients with moderate to severe asthma.

What clinical trials is FlutiForm 250/10 in?

FlutiForm 250/10 has one completed Phase 3 clinical trial, identified as NCT00649025. This randomized, double-blind, active-controlled study enrolled 438 participants with moderate to severe asthma across multiple countries, including the United States, Argentina, Chile, Hungary, Mexico, Peru, Poland, Romania, South Africa, and Ukraine.

Is FlutiForm 250/10 the same as fluticasone and formoterol combination?

Yes, FlutiForm 250/10 is a combination product containing fluticasone and formoterol. It is being developed as a fixed-dose combination for the treatment of asthma. The drug is currently in Phase 3 clinical development and is not yet approved.