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GW815SF Salmeterol/Fluticasone propionate

Phase 3

Bronchial Asthma | Small molecule | Respiratory |GSK plc|Last Updated: May 6, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00449046Clinical Assessment Of GW815SF Salmeterol/Fluticasone Propionate(HFA MDI) In Pediatric Patients With Bronchial Asthma -A Long Term (24-week) Study-PHASE3 COMPLETED 40 — — Mar 1, 2007Nov 1, 2007May 6, 20153 Japan
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Study Endpoints
Primary Endpoints
Most Frequent Adverse Events - On Therapy
Baseline to Week 24

Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead electrocardiogram (ECG), Oropharyngeal examination were included.

Serious Adverse Events (SAEs) - On Therapy
Baseline to Week 24

Number of participants considered by the investigator to be related to study medication. Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead ECG, Oropharyngeal examination were included. Frequency threshold of reported SAE's is 0%(100% reported)

Secondary Endpoints
Change From Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 1-24
Baseline and during Weeks 1-24
Change From Baseline in Percent Predicted Morning Peak Expiratory Flow (PEF) During Weeks 1-24
Baseline and during Weeks 1-24
Change From Baseline in Evening Peak Expiratory Flow (PEF) During Weeks 1-24
Baseline and during Weeks 1-24
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
GW815SF Salmeterol/Fluticasone propionate(HFA MDI)DRUG -
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Eligibility Criteria
Age Range5 Years — 14 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion criteria: * Inclusion Criteria for Entry in Run-in Period A pediatric patient already diagnosed as having bronchial asthma who meets all of the following criteria is eligible for the study: * Male or female patients aged ≥5 and ≤14 years. Enrolment of a female patient of childbearing po...

Countries:Japan
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