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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01033396
First received: December 14, 2009
Last updated: August 16, 2010
Last verified: August 2010
  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 2

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:


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:
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 April 14, 2014