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SKP FlutiForm HFA pMDI

Phase 3

Asthma | Small molecule | Respiratory |Abbott Laboratories|Last Updated: Jun 23, 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment280

FDA Designations

No designations recorded

Clinical trial landscape

SKP FlutiForm HFA pMDI · 1 trial · 1 indication

Phase 3 1
NCT00747318A Phase 3, Multicenter, Open-label Continuation Study in Moderate to Severe Asthmatic Subjects Who Completed FlutiForm HFA pMDI Study SKY2028-3-005Asthma
COMPLETED280 Analytics
PHASE3COMPLETED
A Phase 3, Multicenter, Open-label Continuation Study in Moderate to Severe Asthmatic Subjects Who Completed FlutiForm HFA pMDI Study SKY2028-3-005
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

To assess the long-term safety and efficacy of FlutiForm HFA pMDI 250/10 mcg bid in adolescents and adults with moderate to severe asthma who have completed the study SKY2028-3-005
week 60
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -

Interventions

NameTypeDescription
SKP FlutiForm HFA pMDIDRUGEach subject will receive SKP FlutiForm HFA pMDI 250/10 microgram twice daily for 60 weeks (two actuations of SKP FlutiForm HFA pMDI 125/5 microgram/actuation) for a total daily dose of 500 microgram fluticasone propionate and 20 microgram formoterol fumarate.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites39

Inclusion Criteria: * 1\. Documented use of an inhaled corticosteroid for at least 4 weeks prior to the Day 1 (Baseline) visit and at a dose not greater than 500 mcg/day fluticasone propionate inhalation (or equivalent dose for other inhaled corticosteroids). Subjects who enroll in this study SKY20...

Countries:United StatesMexicoPeruRomaniaUkraine
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Frequently asked questions about SKP FlutiForm HFA pMDI

What is SKP FlutiForm HFA pMDI used for?

SKP FlutiForm HFA pMDI is an investigational small molecule being developed for the treatment of asthma. It is a pressurized metered-dose inhaler formulation studied in patients with moderate to severe asthma. As of the available data, it is in Phase 3 clinical development and is not yet approved by regulatory authorities.

Who makes SKP FlutiForm HFA pMDI?

SKP FlutiForm HFA pMDI 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 asthma, and it remains investigational, meaning it has not yet received regulatory approval.

What phase is SKP FlutiForm HFA pMDI in?

SKP FlutiForm HFA pMDI is in Phase 3 clinical development. It is being studied as a treatment for asthma in a completed Phase 3 trial. The drug is investigational and has not been approved by the FDA or other regulatory agencies.

What clinical trials is SKP FlutiForm HFA pMDI in?

SKP FlutiForm HFA pMDI has one completed Phase 3 clinical trial registered under NCT00747318. This open-label continuation study enrolled 280 participants with moderate to severe asthma across the United States, Mexico, Peru, Romania, and Ukraine. The trial was not randomized or double-blinded and did not use a control group.

Is SKP FlutiForm HFA pMDI the same as FlutiForm HFA pMDI?

SKP FlutiForm HFA pMDI is the drug name used in the clinical trial record, and the trial title refers to it as FlutiForm HFA pMDI. The drug is being developed by Abbott Laboratories for asthma and is currently in Phase 3 clinical development.