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Short Acting Beta Agonist

Phase 3

Asthma | Small molecule | Respiratory |GSK plc|Last Updated: Apr 4, 2016

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
UNCONTROLLED
Total Trials1
Total Enrollment767
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02293265Cross-sectional Study for Identification and Description of Severe Asthma PatientsPHASE3 COMPLETED 767Dec 1, 2014May 1, 2015Apr 4, 201674 United States, Australia +4
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Study Endpoints
Primary Endpoints
Number of severe asthma patients eligible for one or more biologic treatments for asthma
Day 1

Biologic treatments for asthma will include mepolizumab (anti-Interleukin \[IL\] 5), omalizumab (anti-immunoglobulin E \[IgE\]), and reslizumab (anti-IL5).

Secondary Endpoints
Mean and median frequency of planned and unplanned asthma-related healthcare resource utilization in the prior 12 months
Day 1
Mean and median Charlson Comorbidity Index score
Day 1
Mean pre-bronchodilator forced expiratory volume in 1 sec (FEV1)/forced vital capacity (FVC) ratio
Day 1
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
Treatment Arms
ArmTypeDescription
Non-drug interventional groupOTHERAll enrolled participants will provide a blood sample, spirometry , and feedback on their severe asthma symptoms via questionnaires, and health related quality of life and burden of illness through response to self-administered questionnaires. No investigational product will be administered to participants.
Interventions
NameTypeDescription
Short Acting Beta Agonist (SABA)DRUGParticipants requiring a spirometry measurement will be administered a SABA in a metered dose inhaler (MDI) during the reversibility assessments
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites74

Inclusion Criteria: * At least 12 years of age at study visit. * Participants eligible for enrolment and entry into the study must meet the following definition of severe asthma, which is based on the definition of severe asthma described in the European Respiratory Society/ American Thoracic Socie...

Countries:United StatesAustraliaCanadaFranceGermanyUnited Kingdom
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