A Study to Test a New Decongestant in Patients With Allergic Rhinitis Following a Nasal Allergen Challenge
Information source: Pfizer
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allergic Rhinitis
Intervention: Placebo (Drug); Allegra (Drug); Allegra-D (Drug); PF-03654746 (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Summary
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.
Clinical Details
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.
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Pharmacodynamics Study
Primary outcome: Acoustic rhinometry measurements pre and post dose following nasal allergen challenge at each of 4 study visits
Secondary outcome: Symptom scores pre and post dose following nasal allergen challenge at each of 4 study visitsBlood sample for pharmacokinetics post dose at each of 4 study visits
Eligibility
Minimum age: 19 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female subjects 19-55 years with allergic rhinitis requiring treatment within
the previous 2 years.
- Subjects that respond to a ragweed nasal allergen challenge at screening.
Exclusion Criteria:
- History of asthma or FEV1 < 80% predicted.
- Significant concomitant disease or medications.
- Symptoms of allergic rhinitis within 2 weeks prior to screening.
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Pfizer Investigational Site, Omaha, Nebraska 68131, United States; Recruiting
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: December 2007
Ending date: August 2008
Last updated: July 7, 2008
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