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Combination DSCG and Reproterol

Phase 2

Asthma, Exercise-Induced | Small molecule | Respiratory |Viatris Inc.|Last Updated: Feb 7, 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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment62
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00777348To Assess the Protective Effect of the Fixed Drug Combination of Disodium Cromoglycate Plus ReproterolPHASE2 COMPLETED 62Nov 1, 2007Oct 1, 2008Feb 7, 20227 Germany
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Study Endpoints
Primary Endpoints
Primary objective: to demonstrate superiority of the protective effect of the fixed combination of disodium cromoglycate (DSCG) plus reproterol in comparison to the single component reproterol in adults suffering from exercise induced asthma (EIA).
5, 10, 15, 30 and 60 minutes after drug application
Secondary Endpoints
Secondary objectives: to demonstrate superiority of the protective effect of DSCG plus reproterol in comparison to the single component DSCG; to demonstrate superiority of the protective effect of each single component in comparison to placebo.
5, 10, 15, 30 and 60 minutes after drug application
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALDSCG + Reproterol
2ACTIVE_COMPARATORDSCG
3ACTIVE_COMPARATORReproterol
4PLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
Combination DSCG and ReproterolDRUG1:
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Female and male subjects aged 18 - 65 years * Exercise induced asthma with reversible airway obstruction: twice proven EIA defined as maximum decrease in FEV1 against the baseline value of at least 20% (first test results can be obtained during the last 12 months) * Baseline F...

Countries:Germany
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