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PF-04191834

Phase 2

Asthma | Small molecule | Respiratory |Pfizer, Inc.|Last Updated: Feb 1, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Clinical trial landscape

PF-04191834 · 1 trial · 1 indication

Phase 2 1
NCT00723021PF-04191834 Single Dose Bronchodilatory Study In Asthma.Asthma
COMPLETED15 Analytics
PHASE2COMPLETED
PF-04191834 Single Dose Bronchodilatory Study In Asthma.
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Baseline, 12 hours (hrs) post-dose

The FEV1 is the maximal volume of air that can be forcefully exhaled in one second

Secondary Endpoints

Change From Baseline in Forced Vital Capacity (FVC)
Baseline, 12 hours (hrs) post-dose
Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75)
Baseline, 12 hours (hrs) post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PF-04191834 30mgEXPERIMENTAL -
PF-04191834 100mgEXPERIMENTAL -
PF-04191834 2000mgEXPERIMENTAL -
zileutonACTIVE_COMPARATOR -
placeboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PF-04191834DRUG30mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets.
zileutonDRUG1200mg, 2 x 600mg tablets, single dose + placebo oral dispersion, single dose.
PlaceboDRUG2 x placebo tablets + placebo oral dispersion, single dose.
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Persistent mild/moderate asthma for at least 6 months. * Reduced lung function * Reversible airway obstruction Exclusion Criteria: * Pregnant/nursing females. * Liver function tests greater than upper limit of normal (ULN)

Countries:United States
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Frequently asked questions about PF-04191834

What is PF-04191834 used for?

PF-04191834 is an investigational small molecule being developed for the treatment of asthma. It is a respiratory therapeutic that has been studied in a Phase 2 clinical trial. The drug is not approved and remains in clinical development.

Who makes PF-04191834?

PF-04191834 is being developed by Pfizer, Inc., which is publicly traded under the ticker symbol PFE on the New York Stock Exchange. The company conducted a Phase 2 clinical trial of the drug in patients with asthma.

What phase is PF-04191834 in?

PF-04191834 is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a single-dose bronchodilatory study in asthma. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is PF-04191834 in?

PF-04191834 has been studied in one completed Phase 2 clinical trial, identified as NCT00723021. This trial was a single-dose bronchodilatory study in asthma, conducted in the United States with 15 participants. The trial was randomized, double-blind, and placebo-controlled.

Is PF-04191834 FDA approved?

PF-04191834 is not FDA approved. It is an investigational drug that has completed a Phase 2 clinical trial for asthma. The drug is still in clinical development and has not been authorized for marketing or use by patients.