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Completed

NCT Number: NCT01033396

The Effect Of PF-03654764 +/- Allegra On Symptoms Of Allergic Rhinitis

PF-03654764 should reduce the symptoms of allergic rhinitis. In this study patients will be exposed to pollen and their symptoms observed.

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site

Kingston, Ontario, K7L 2V7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female subjects 18-60 years allergic to ragweed pollen.
  • Subjects with appropriate symptom scores following exposure to ragweed in the environmental exposure unit.

Exclusion criteria

  • Subjects with significant diseases other than allergic rhinitis that may interfere with the safety or efficacy of PF-03654764.
  • Subjects with significant symptoms of allergic rhinitis within the 2 weeks prior to screening.

Treatment and study plan

PF-03654764

Drug

PF-03654764 single dose 5 mg

Allegra

Drug

Fexofenadine single dose 60 mg

Allegra-D

Drug

Fexofenadine 60 mg combined with pseudoephedrine 120 mg single dose

Placebo

Drug

Placebo single dose

Primary outcomes

  1. Congestion scores

    Time frame: 6 hours

  2. Other allergic rhinitis symptoms

    Time frame: 6 hours

Secondary outcomes

  1. Pharmacokinetics

    Time frame: 6 hours

  2. Blood pressure/pulse rate

    Time frame: 6 hours

  3. Adverse event reporting

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Randomized, Double Blind, Placebo Controlled, Four Way Crossover Study To Determine The Effects Of PF-03654764 +/- Allegra (Fexofenadine) On Symptoms Of Allergic Rhinitis In Subjects Exposed To Ragweed Pollen In An Environmental Exposure Unit.

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 16, 2009
Registry last updated
Aug 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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