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Lactose

Phase 2

Acute Lung Injury | Small molecule | Other |United Therapeutics Corporation|Last Updated: Sep 13, 2022

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-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment33
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01659307The Effect of Aspirin on REducing iNflammation in Human in Vivo Model of Acute Lung InjuryPHASE2 COMPLETED 33Sep 1, 2012Sep 9, 2022Sep 13, 20221 United Kingdom
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Study Endpoints
Primary Endpoints
Bronchoalveolar lavage IL-8 concentration
6 hrs after LPS inhalation
Secondary Endpoints
Alveolar inflammatory response biomarkers
6 hrs after LPS inhalation
Plasma inflammatory response biomarkers
6 and 24 hrs after LPS inhalation
Alveolar epithelial and endothelial function and injury biomarkers
6 hrs after LPS inhalation
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Aspirin 75mgACTIVE_COMPARATORAspirin 75mg once daily for 7 days. Administered by mouth.
Aspirin 1200mgACTIVE_COMPARATORAsprin 600mg twice daily for 7 days. Administered by mouth.
Lactose powderPLACEBO_COMPARATORPlacebo for 7 days. Administered by mouth.
Interventions
NameTypeDescription
Aspirin 75mgDRUGSubjects randomised to aspirin 75mg will receive 1 container containing aspirin 75mg and 1 container containing placebo for the morning and 2 containers containing placebo for the evening. Subjects will take one capsule from each container in the morning and one capsule from each container in the evening.
Lactose powderDRUGSubjects randomised to placebo will receive 4 containers of placebo, 2 containers containing placebo for the morning and 2 containers containing placebo for the evening. Subjects will take one capsule from each container in the morning and one capsule from each container in the evening.
Aspirin 1200mgDRUGSubjects randomised to aspirin 600mg 12 hourly will receive 2 containers of aspirin 300mg each for the morning and 2 containers of aspirin 300mg each for the evening. Subjects will take one capsule from each container in the morning and one capsule from each container in the evening.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy subjects Exclusion Criteria: * Age \< 18 years * Pregnancy or breast feeding or woman of childbearing potential not using * adequate contraception. * Participation in a clinical trial of an investigational medicinal product within 30 days * Consent declined Aspirin o...

Countries:United Kingdom
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