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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Allergic Rhinitis

Treatments: Drug: Allegra-D; Drug: Allegra; Drug: Placebo; Drug: PF-03654764

Study type: Interventional

Funder types: Industry

Identifiers

NCT01033396

B0711005

Details and patient eligibility

About

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

Enrollment: 64 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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64 participants in 4 patient groups, including a placebo group

PF-03654764 + Allegra

Experimental group

Treatment:

Drug: PF-03654764

Drug: Allegra

Drug: PF-03654764

PF-03654764

Experimental group

Treatment:

Drug: PF-03654764

Drug: PF-03654764

Allegra-D

Active Comparator group

Treatment:

Drug: Allegra-D

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo