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FP

Phase 3

Asthma | Small molecule | Respiratory |GSK plc|Trials Updated: Nov 25, 2016

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment1,053

FDA Designations

No designations recorded

FP clinical trials

FP · 2 trials · 1 indication

Phase 3 1Phase 2 1
NCT00920959Advair Pediatric Once-DailyAsthma
COMPLETED908 Analytics
PHASE3COMPLETED
Advair Pediatric Once-Daily
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline at endpoint in daily PM PEF
12 weeks
Trough (AM pre-dose and pre-rescue bronchodilator) FEV1
at the end of the 6 week treatment period.

Secondary Endpoints

Various pulmonary function endpoints
12 weeks
• Daily trough (AM pre-dose and pre-rescue bronchodilator) AM PEF
averaged over the last 3 weeks of the 6 week treatment period.
• Daily PM PEF
averaged over the last 3 weeks of the 6 week treatment period.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Fluticasone propionate/salmeterol combinationEXPERIMENTALstudy drug
Fluticasone propionateEXPERIMENTALstudy drug
PlaceboEXPERIMENTALplacebo
FP/SAL 250/50mcg BID plus GSK2190915 300mg QD (AM)EXPERIMENTALFP/SAL 250/50mcg BID plus GSK2190915 300mg QD (AM)
FP/SAL 250/50mcg BID plus montelukast 10mg QD (PM)ACTIVE_COMPARATORFP/SAL 250/50mcg BID plus montelukast 10mg QD (PM)
FP/SAL 250/50mcg BID plus placebo BIDPLACEBO_COMPARATORP/SAL 250/50mcg BID plus placebo BID

Interventions

NameTypeDescription
FP 100mcgDRUGOnce-daily dosing
FSC 100/50mcgDRUGOnce-daily dosing
PlaceboDRUGOnce-daily dosing
FP/SAL 250/50mcg BIDDRUGFP/SAL 250/50mcg BID
GSK2190915 200mg QD (AM)DRUGGSK2190915 200mg QD (AM)
GSK2190915 100mg QD (AM)DRUGGSK2190915 100mg QD (AM)
Montelukast 10mg QD (PM)DRUGMontelukast 10mg QD (PM)
Placebo tablets (2) (AM)DRUGPlacebo tablets (2) (AM)
Placebo capsule (PM)DRUGPlacebo capsule (PM)
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Eligibility Criteria

Age Range4 Years to 11 Years
SexALL
Healthy VolunteersNo
Study Sites149

Inclusion Criteria: * Out-patients * Asthma diagnosis * Reversibility * Short-acting beta-agonist or asthma controlled medication use Exclusion Criteria: * Life-threatening asthma * Specified asthma medications * Chickenpox * Drug allergy * Respiratory infections * Tobacco use * Clinical laborato...

Countries:United StatesArgentinaChilePeruPuerto RicoBulgariaPolandUkraine
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Frequently asked questions about FP

What is FP used for?

FP is used for the treatment of asthma. It is a small molecule therapy in the respiratory therapeutic area. The clinical program for FP includes studies in patients with asthma, evaluating its use in combination with an inhaled corticosteroid and long acting beta agonist.

Who is developing FP?

FP is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical trials evaluating FP in asthma.

What phase is FP in?

FP is in Phase 3 clinical development for asthma. The program includes a completed Phase 3 trial and a completed Phase 2 trial. FP is investigational and has not been approved by the FDA for any indication.

What clinical trials is FP in?

FP has been studied in two completed clinical trials. NCT00920959 was a Phase 3 trial titled Advair Pediatric Once-Daily, which enrolled 908 participants with asthma. NCT01248975 was a Phase 2 trial evaluating the addition of GSK2190915 to mid-dose inhaled corticosteroid and long acting beta agonist combination treatment, enrolling 145 participants.