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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00562120
First received: November 19, 2007
Last updated: November 12, 2010
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Allergic Rhinitis
 Drug: Placebo
Drug: Allegra
Drug: Allegra-D
Drug: PF-03654746
 Phase 2

Study Type: Interventional
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.

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 19
Study Start Date: December 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo 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.
Active Comparator: Allegra Drug: Allegra
A single oral dose of Allegra is dosed to subjects in combination with PF-03654746.
Active Comparator: Allegra-D Drug: Allegra-D
A single oral dose of Allegra-D is dosed to subjects as an active comparator.
Experimental: PF-03654746 Drug: PF-03654746
A single oral dose of PF-03654746 is the investigational drug being studied.

  Eligibility

Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00562120

Locations
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00562120     History of Changes
Other Study ID Numbers: A8801003
Study First Received: November 19, 2007
Last Updated: November 12, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Fexofenadine
 Histamine H3 Antagonists
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013