Back to resultsEffect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen
Primary Purpose
Allergic Rhinitis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
fluticasone furoate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis
Eligibility Criteria
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.
Sites / Locations
- University of Chicago Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Veramyst, then Placebo
Placebo, then Veramyst
Arm Description
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
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
Outcomes
Primary Outcome Measures
Change in Tryptase Level From Baseline to Post-antigen Challenge
Tryptase levels (mcg/L) were measured from nasal lavages
Secondary Outcome Measures
Total Eye Symptom Scores After Antigen Challenge
Watery and itchy eye symptoms will be scored based on the following scale: 0=no symptoms, 1= mild, 2= moderate, 3= severe
Full Information
NCT ID
NCT00791973
First Posted
November 13, 2008
Last Updated
June 6, 2014
Sponsor
University of Chicago
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00791973
Brief Title
Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen
Official Title
Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chicago
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Veramyst, then Placebo
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo, then Veramyst
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
fluticasone furoate
Other Intervention Name(s)
Veramyst
Intervention Description
2 puffs in each nostril once daily for 1 week
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 puffs in each nostril once daily for 1 week
Primary Outcome Measure Information:
Title
Change in Tryptase Level From Baseline to Post-antigen Challenge
Description
Tryptase levels (mcg/L) were measured from nasal lavages
Time Frame
After one week of treatment wtih veramyst or placebo
Secondary Outcome Measure Information:
Title
Total Eye Symptom Scores After Antigen Challenge
Description
Watery and itchy eye symptoms will be scored based on the following scale: 0=no symptoms, 1= mild, 2= moderate, 3= severe
Time Frame
After one week of treatment wtih veramyst or placebo
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Naclerio, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen
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