A Study to Test a New Decongestant in Patients With Allergic Rhinitis Following a Nasal Allergen Challenge
An H3 receptor antagonist should reduce the congestion associated with allergic rhinitis. A nasal allergen challenge will be given to patients to induce rhinitis symptoms and acoustic rhinometry will be used to measure the congestion.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double Blind, Double Dummy, Placebo Controlled, Four Way Crossover Study To Determine The Effects Of An H3 Receptor Antagonist (PF-03654746) On Congestion Following A Nasal Allergen Challenge In Subjects With Seasonal Allergic Rhinitis.|
- Acoustic rhinometry measurements pre and post dose following nasal allergen challenge at each of 4 study visits [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- Symptom scores pre and post dose following nasal allergen challenge at each of 4 study visits [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- Blood sample for pharmacokinetics post dose at each of 4 study visits [ Time Frame: 2 months ] [ Designated as safety issue: No ]
|Study Start Date:||December 2007|
|Study Completion Date:||August 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo||
A single oral dose of Placebo is dosed during the study in order to ascertain the effect of placebo on measures and in order to maintain the blind of the other drugs.
|Active Comparator: Allegra||
A single oral dose of Allegra is dosed to subjects in combination with PF-03654746.
|Active Comparator: Allegra-D||
A single oral dose of Allegra-D is dosed to subjects as an active comparator.
A single oral dose of PF-03654746 is the investigational drug being studied.