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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Rhinitis, Allergic, Perennial
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Fexofenadine
Anti-Allergic Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014