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

Allergic Rhinitis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01033396
• Other study ID #: B0711005
• Status: Completed
• Phase: Phase 2
• First received: December 14, 2009
• Last updated: August 16, 2010
• Start date: January 2010
• Est. completion date: May 2010

Study information

• Verified date: August 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Authority
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

Intervention

Drug:
• PF-03654764
PF-03654764 single dose 5 mg
• Allegra
Fexofenadine single dose 60 mg
• PF-03654764
PF-03654764 single dose 5 mg
• Allegra-D
Fexofenadine 60 mg combined with pseudoephedrine 120 mg single dose
• Placebo
Placebo single dose

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Congestion scores		6 hours	No
Primary	Other allergic rhinitis symptoms		6 hours	No
Secondary	Pharmacokinetics		6 hours	No
Secondary	Blood pressure/pulse rate		6 hours	Yes
Secondary	Adverse event reporting		2 months	Yes

External Links

•   To obtain contact information for a study center near you, click here.