The Effect Of PF-03654764 +/- Allegra On Symptoms Of Allergic Rhinitis

A Randomized, Double Blind, Placebo Controlled, Four Way Crossover Study To Determine The Effects Of PF-03654764 +/- Allegra (Fexofenadine) On Symptoms Of Allergic Rhinitis In Subjects Exposed To Ragweed Pollen In An Environmental Exposure Unit.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01033396

Enrollment

Registered

2009-12-16

Start date

2010-01-31

Completion date

2010-05-31

Last updated

2010-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

Keywords

Allergic rhinitis Environmental exposure unit

Brief summary

PF-03654764 should reduce the symptoms of allergic rhinitis. In this study patients will be exposed to pollen and their symptoms observed.

Interventions

DRUGPF-03654764

PF-03654764 single dose 5 mg

DRUGAllegra

Fexofenadine single dose 60 mg

DRUGAllegra-D

Fexofenadine 60 mg combined with pseudoephedrine 120 mg single dose

DRUGPlacebo

Placebo single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Male or female subjects 18-60 years allergic to ragweed pollen. * Subjects with appropriate symptom scores following exposure to ragweed in the environmental exposure unit.

Exclusion criteria

* Subjects with significant diseases other than allergic rhinitis that may interfere with the safety or efficacy of PF-03654764. * Subjects with significant symptoms of allergic rhinitis within the 2 weeks prior to screening.

Design outcomes

Primary

Measure	Time frame
Congestion scores	6 hours
Other allergic rhinitis symptoms	6 hours

Secondary

Measure	Time frame
Pharmacokinetics	6 hours
Blood pressure/pulse rate	6 hours
Adverse event reporting	2 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026