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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT01033396

Purpose

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

Condition	Intervention	Phase
Allergic Rhinitis	Drug: PF-03654764 Drug: Allegra Drug: Allegra-D Drug: Placebo	Phase II

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

Resource links provided by NLM:

Drug Information available for: Fexofenadine Fexofenadine hydrochloride Allegra-D

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Congestion scores [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Other allergic rhinitis symptoms [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacokinetics [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Blood pressure/pulse rate [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
Adverse event reporting [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Enrollment:	64
Study Start Date:	January 2010
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: PF-03654764 + Allegra	Drug: PF-03654764 PF-03654764 single dose 5 mg Drug: Allegra Fexofenadine single dose 60 mg
Experimental: PF-03654764	Drug: PF-03654764 PF-03654764 single dose 5 mg
Active Comparator: Allegra-D	Drug: Allegra-D Fexofenadine 60 mg combined with pseudoephedrine 120 mg single dose
Placebo Comparator: Placebo	Drug: Placebo Placebo single dose

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01033396

Locations

Canada, Ontario
Pfizer Investigational Site
Kingston, Ontario, Canada, K7L 2V7

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT01033396 History of Changes
Other Study ID Numbers:	B0711005
Study First Received:	December 14, 2009
Last Updated:	August 16, 2010
Health Authority:	Canada: Health Authority

Keywords provided by Pfizer:

Allergic rhinitis Environmental exposure unit

Additional relevant MeSH terms:

Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Fexofenadine
Anti-Allergic Agents
Therapeutic Uses

Pharmacologic Actions
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012