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QAT370

Phase 1

Chronic Obstructive Pulmonary Disease | Small molecule | Other |Novartis AG|Last Updated: Dec 19, 2020

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment22
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00532350Safety and Tolerability QAT370 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary DiseasePHASE1 COMPLETED 22Jul 1, 2007Jan 1, 2008Dec 19, 20203 Germany
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Study Endpoints
Primary Endpoints
Forced expiratory volume in 1 second
Days 1 and 7
Secondary Endpoints
Forced expiratory volume in 1 second and corresponding parameters for inspiratory capacity.
Days 1 and 7
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALQAT370
2PLACEBO_COMPARATORPlacebo
3ACTIVE_COMPARATORTiotropium
Interventions
NameTypeDescription
QAT370DRUG -
PlaceboDRUG -
TiotropiumDRUG -
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Eligibility Criteria
Age Range40 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Patients between 40 and 80 years of age with controlled COPD. * Women must be surgically sterilized or postmenopausal. Additional birth control and post-menopausal information will be available at time of enrollment. * Body mass index (BMI) must be within the range of 18 to 32...

Countries:Germany
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