Recent Updates
Recently added Catalysts

Meptin Swinghaler

Phase 3

Asthma | Small molecule | Respiratory |Co-Diagnostics, Inc.|Last Updated: Aug 12, 2010

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedCONTROLLED
Total Trials1
Total Enrollment17
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01076322A Study to Evaluate the Efficacy and Safety of Meptin® Swinghaler® and Ventolin® MDI in Stable Asthma PatientsPHASE3 COMPLETED 17Mar 1, 2009Jun 1, 2010Aug 12, 20101 Taiwan
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
The change in Forced Expiratory Volume in 1 second (FEV1) value.
2 days
Secondary Endpoints
The change in sGaw
2 days
The changes in IOS parameters (R, X and RF)
2 days
The change in Peak Expiratory Flow Rate (PEFR)
2 days
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment-A sequenceEXPERIMENTALMeptin® Swinghaler / Ventolin® MDI
Treatment-B sequenceEXPERIMENTALVentolin® MDI / Meptin® Swinghaler
Interventions
NameTypeDescription
Meptin® SwinghalerDRUGMeptin® Swinghaler® * Ingredient: Procaterol HCL * Dosage form: 10g/puff * Dose(s): 10g * Dosing schedule: 20g (total 20g)
Ventolin® MDIDRUGVentolin® MDI * Ingredient: Salbutamol sulfate * Dosage form: 100g/puff * Dose(s): 100g * Dosing schedule: 200g (total 200g)
Unlock Study Design Details
Eligibility Criteria
Age Range16 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Male or females outpatients aged ≥ 16 years old with stable mild to moderate persistent asthma; Stability was assessed the patient remained in the same severity class (mild, moderate) and had no acute exacerbations by investigator judgment during the past 14 days; 2. Pulmonar...

Countries:Taiwan
Unlock Eligibility Criteria