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Dose 1 BD

Phase 2

Asthma | Small molecule | Respiratory |GSK plc|Last Updated: Jan 30, 2017

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
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment75
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00980200Efficacy and Safety Study in Subjects With AsthmaPHASE2 COMPLETED 75Sep 1, 2009Jan 1, 2010Jan 30, 20179 United States
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Study Endpoints
Primary Endpoints
Change From Baseline in Trough (Pre-bronchodilator and Pre-dose) FEV1 on Day 7 of the Treatment Period
Baseline and Day 7 of the treatment period (up to Study Day 63)

Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the mean of the FEV1 values obtained at the last two scheduled time points at the Day 7 clinic visit (i.e., 11 and 12 hours after the morning dose, or 23 and 24 hours after the evening dose). Change from Baseline was calculated as the Day 7 value minus the Baseline value. Analysis was performed using a mixed model analysis of covariance (ANCOVA) with fixed effects of treatment, period, sex, and age. Participants is fitted as a random effect, and the period Baseline measurement is included as part of a bivariate response. The model for the period Baseline value is not affected by treatment group.

Secondary Endpoints
Change From Baseline in Weighted Mean 24-hour FEV1 on Day 7 of the Treatment Period
Baseline and Day 7 of the treatment period (up to Study Day 63)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
C/E/A/B/DEXPERIMENTALGW642444 Dose 2 QD/GW642444 Dose 4 QD/placebo/GW642444 Dose 1 BD/GW642444 Dose 3 QD
D/C/E/A/BEXPERIMENTALGW642444 Dose 3 QD/GW642444 Dose 2 QD/GW642444 Dose 4 QD/placebo/GW642444 Dose 1 BD
A/B/C/D/EEXPERIMENTALplacebo/GW642444 Dose 1 BD/GW642444 Dose 2 QD/GW642444 Dose 3 QD/GW642444 Dose 4 QD
B/A/D/E/CEXPERIMENTALGW642444 Dose 1 BD/placebo/GW642444 Dose 3 QD/GW642444 Dose 4 QD/GW642444 Dose 2 QD
E/D/B/C/AEXPERIMENTALGW642444 Dose 4 QD/GW642444 Dose 3 QD/GW642444 Dose 1 BD/GW642444 Dose 2 QD/placebo
Interventions
NameTypeDescription
Dose 4 QDDRUGQD once daily
Dose 3 QDDRUGQD once daily
placeboDRUGplacebo
Dose 2 QDDRUGQD once daily
Dose 1 BDDRUGBD twice daily
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Outpatient * ≥18 years of age at Visit 1 * Male or Eligible Female * Diagnosis of asthma at least 12 weeks prior to Visit 1 * Disease reversibility * Current anti-asthma therapy * Appropriately signed and dated informed consent has been obtained * Able to comply with all the s...

Countries:United States
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