Recent Updates
Recently added Catalysts

PF-00610355

Phase 2

Pulmonary Disease, Chronic Obstructive | Small molecule | Other |Pfizer, Inc.|Last Updated: Feb 6, 2019

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment425
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00808288A Study To Investigate The Safety, Toleration And Efficacy of PF00610355 In Chronic Obstructive Pulmonary Disease (COPD) Patients.PHASE2 COMPLETED 405Mar 1, 2010Dec 1, 2010Feb 6, 201975 United States, Argentina +10
NCT00783406Safety, Toleration and Efficacy of Single Inhaled Doses of PF-00610355 in Chronic Obstructive Pulmonary (COPD) Patients.PHASE2 COMPLETED 20Oct 1, 2008Mar 1, 2009Nov 1, 20102 Germany
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Change from baseline in trough FEV1
6 week
To characterize the single dose pharmacokinetics of inhaled PF-00610355 in COPD patients.
up to 8 days post dose
To evaluate the safety & toleration of single inhaled doses of PF-00610355 in COPD patients
up to 24 hours post dose
Secondary Endpoints
Maximal and mean changes from baseline in heart rate, QTc and plasma potassium
each visit
Change from baseline in peak FEV1
0-6 hours /6 weeks
Change from baseline in trough and peak FEV6, FVC and IC
6 weeks
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PF-00610355EXPERIMENTAL -
PF- 00610355EXPERIMENTAL -
PF - 00610355EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
SalmeterolACTIVE_COMPARATOR -
PF -00610355EXPERIMENTAL -
Interventions
NameTypeDescription
PF-00610355DRUGoral, inhaled, dry powder, 600ug, OD
PF - 00610355DRUGoral, inhaled, dry powder, 300ug, OD
PF- 00610355DRUGoral, inhaled, dry powder, 100ug, OD
PlaceboDRUGoral, inhaled, dry powder, placebo, OD
SalmeterolDRUGsalmeterol, 50ug, BID
Unlock Study Design Details
Eligibility Criteria
Age Range40 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites75

Inclusion Criteria: * Post-bronchodilator FEV1/FVC ratio \<0.7 and a post-bronchodilator FEV1 of 50-80%. * Diagnosis of moderate COPD for a minimum of 6 months. * Stable disease for at least 1 month prior to screening Exclusion Criteria: * More than 2 exacerbations of COPD requiring treatment wit...

Countries:United StatesArgentinaBulgariaCroatiaCzechiaGermanyHungaryPolandSlovakiaSouth AfricaSpainTurkey (Türkiye)
Unlock Eligibility Criteria