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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00562120

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 II

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

Drug Information available for: Histamine Tritium Fexofenadine Fexofenadine hydrochloride Allegra-D

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 February 09, 2012