Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Nov 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 13, 2008
CompletedFirst Posted
Study publicly available on registry
November 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedResults Posted
Study results publicly available
July 8, 2014
CompletedJuly 8, 2014
June 1, 2014
5 months
November 13, 2008
June 6, 2014
June 6, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Tryptase Level From Baseline to Post-antigen Challenge
Tryptase levels (mcg/L) were measured from nasal lavages
After one week of treatment wtih veramyst or placebo
Secondary Outcomes (1)
Total Eye Symptom Scores After Antigen Challenge
After one week of treatment wtih veramyst or placebo
Study Arms (2)
Veramyst, then Placebo
ACTIVE COMPARATORfluticasone 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, then Veramyst
ACTIVE COMPARATORplacebo nasal spray once daily for a week, then one week washout period followed by fluticasone furoate (veramyst) nasal spray once daily for a week
Interventions
2 puffs in each nostril once daily for 1 week
2 puffs in each nostril once daily for 1 week
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
- Pregnant or lactating women.
- Upper respiratory infection within 14 days of study start.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Chicagolead
- GlaxoSmithKlinecollaborator
Study Sites (1)
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Robert Naclerio
- Organization
- University of Chicago
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Naclerio, MD
University of Chicago
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
November 13, 2008
First Posted
November 17, 2008
Study Start
November 1, 2008
Primary Completion
April 1, 2009
Study Completion
May 1, 2010
Last Updated
July 8, 2014
Results First Posted
July 8, 2014
Record last verified: 2014-06