Intranasal Steroids and the Nasal Ocular Response

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Robert Naclerio, University of Chicago
ClinicalTrials.gov Identifier:
NCT00473915
First received: May 14, 2007
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

Eye symptoms of tearing, redness and itch frequently occur in patients with allergic rhinitis or hayfever. The purpose of this study is to learn whether placing allergen (the substance that causes allergies) in the nose several days in a row will cause an increase in eye symptoms and whether receiving a nasal steroid spray will prevent these eye symptoms.


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: fluticasone furoate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intranasal Steroids Prevent Antigen-Induced Hyperresponsiveness of the Nasal Ocular Response

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Change in ocular symptoms [ Time Frame: between days 1 and 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of eosinophils [ Time Frame: between days 1 and 3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: April 2007
Study Completion Date: February 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: fluticasone furoate
    corticosteroid nasal spray
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

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

Exclusion Criteria

  1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
  2. Pregnant or lactating women.
  3. Upper respiratory infection within 14 days of study start.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00473915

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
GlaxoSmithKline
Investigators
Principal Investigator: Robert m Naclerio, MD University of Chicago
  More Information

No publications provided by University of Chicago

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert Naclerio, Professor, University of Chicago
ClinicalTrials.gov Identifier: NCT00473915     History of Changes
Other Study ID Numbers: 15061B
Study First Received: May 14, 2007
Last Updated: May 30, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Fluticasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on August 01, 2014