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

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ClinicalTrials.gov Identifier: NCT00791973
Recruitment Status : Completed
First Posted : November 17, 2008
Results First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Robert Naclerio, University of Chicago

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: fluticasone furoate Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen
Study Start Date : November 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : May 2010

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Veramyst, then Placebo
fluticasone furoate (Veramyst) nasal spray once daily for a week, then one week washout period followed by placebo nasal spray once daily for a week
 Drug: fluticasone furoate
2 puffs in each nostril once daily for 1 week
Other Name: Veramyst

Drug: Placebo
2 puffs in each nostril once daily for 1 week
Active Comparator: Placebo, then Veramyst
placebo nasal spray once daily for a week, then one week washout period followed by fluticasone furoate (veramyst) nasal spray once daily for a week
 Drug: fluticasone furoate
2 puffs in each nostril once daily for 1 week
Other Name: Veramyst

Drug: Placebo
2 puffs in each nostril once daily for 1 week


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791973


Locations
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United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
GlaxoSmithKline
Investigators
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Principal Investigator: Robert Naclerio, MD University of Chicago
More Information
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Responsible Party: Robert Naclerio, MD, University of Chicago
ClinicalTrials.gov Identifier: NCT00791973    
Other Study ID Numbers: 16367B (OC 3)
First Posted: November 17, 2008    Key Record Dates
Results First Posted: July 8, 2014
Last Update Posted: July 8, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
 Fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents