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OpenTrials
Completed

NCT Number: NCT00791973

Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen

The purpose of this study is to help us to a better understanding of how nose and eye symptoms are related in patients with allergies.

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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–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Males and females between 18 and 45 years of age.
  • History of grass and/or ragweed allergic rhinitis.
  • Positive skin test to grass and/or ragweed antigen.
  • Positive response to screening nasal challenge.

Exclusion criteria

  • Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
  • Pregnant or lactating women.
  • Upper respiratory infection within 14 days of study start.

Treatment and study plan

Fluticasone Furoate

Drug

2 puffs in each nostril once daily for 1 week

Other names: Veramyst

Placebo

Drug

2 puffs in each nostril once daily for 1 week

Primary outcomes

  1. Change in Tryptase Level From Baseline to Post-antigen Challenge

    Time frame: After one week of treatment wtih veramyst or placebo

    Tryptase levels (mcg/L) were measured from nasal lavages

Secondary outcomes

  1. Total Eye Symptom Scores After Antigen Challenge

    Time frame: After one week of treatment wtih veramyst or placebo

    Watery and itchy eye symptoms will be scored based on the following scale: 0=no symptoms, 1= mild, 2= moderate, 3= severe

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • GlaxoSmithKline

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Nov 17, 2008
Registry last updated
Jul 8, 2014

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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