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

Phase 2

Completed

• Conditions: Allergic Rhinitis
• Interventions: Drug: PF-03654764; Drug: Placebo; Drug: Allegra-D; Drug: Allegra

• Registration Number: NCT01033396
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-14
• Study First Submitted QC: 2009-12-15
• Study First Posted: 2009-12-16
• Study Start: 2010-01
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-16
• Last Update Posted: 2010-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PF-03654764	PF-03654764	-
Placebo	Placebo	-
PF-03654764 + Allegra	Allegra	-
Allegra-D	Allegra-D	-
PF-03654764 + Allegra	PF-03654764	-

Primary Outcome Measures

Name	Time	Method
Congestion scores	6 hours
Other allergic rhinitis symptoms	6 hours

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics	6 hours
Blood pressure/pulse rate	6 hours
Adverse event reporting	2 months

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇦 Kingston, Ontario, Canada