The Effect Of PF-03654764 +/- Allegra On Symptoms Of Allergic Rhinitis
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.
1 other identifier
interventional
64
1 country
1
Brief Summary
PF-03654764 should reduce the symptoms of allergic rhinitis. In this study patients will be exposed to pollen and their symptoms observed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2009
CompletedFirst Posted
Study publicly available on registry
December 16, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedAugust 17, 2010
August 1, 2010
4 months
December 14, 2009
August 16, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Congestion scores
6 hours
Other allergic rhinitis symptoms
6 hours
Secondary Outcomes (3)
Pharmacokinetics
6 hours
Blood pressure/pulse rate
6 hours
Adverse event reporting
2 months
Study Arms (4)
PF-03654764 + Allegra
EXPERIMENTALPF-03654764
EXPERIMENTALAllegra-D
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Kingston, Ontario, K7L 2V7, Canada
Related Publications (1)
North ML, Walker TJ, Steacy LM, Hobsbawn BG, Allan RJ, Hackman F, Sun X, Day AG, Ellis AK. Add-on histamine receptor-3 antagonist for allergic rhinitis: a double blind randomized crossover trial using the environmental exposure unit. Allergy Asthma Clin Immunol. 2014 Jul 3;10(1):33. doi: 10.1186/1710-1492-10-33. eCollection 2014.
PMID: 25024716DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 14, 2009
First Posted
December 16, 2009
Study Start
January 1, 2010
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
August 17, 2010
Record last verified: 2010-08