A Study to Test a New Decongestant in Patients With Allergic Rhinitis Following a Nasal Allergen Challenge

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.”

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.

Intervention(s) in this Clinical Trial

• Drug: 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.
• Drug: Allegra
  • A single oral dose of Allegra is dosed to subjects in combination with PF-03654746.
• Drug: Allegra-D
  • A single oral dose of Allegra-D is dosed to subjects as an active comparator.
• Drug: PF-03654746
  • A single oral dose of PF-03654746 is the investigational drug being studied.

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Placebo
• Active Comparator: Allegra
• Active Comparator: Allegra-D
• Experimental: PF-03654746

Primary Measures

• Acoustic rhinometry measurements pre and post dose following nasal allergen challenge at each of 4 study visits
  • Time Frame: 2 months
    Safety Issue?: No

Secondary Measures

• Symptom scores pre and post dose following nasal allergen challenge at each of 4 study visits
  • Time Frame: 2 months
    Safety Issue?: No
• Blood sample for pharmacokinetics post dose at each of 4 study visits
  • Time Frame: 2 months
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 19 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00562120

Study ID Number: A8801003

ClinicalTrials.gov Identifier: NCT00562120

Health Authority: United States: Food and Drug Administration

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