Effect of Veramyst and Olopatadine 0.2% Opthalmic Solution on Allergy Symptoms
1 other identifier
interventional
21
1 country
1
Brief Summary
People who have hayfever or allergic rhinitis often complain about eye symptoms associated with their nasal symptoms. How people with hayfever develop eye symptoms is not clear. The purpose of this study is to better understand the generation of eye symptoms in patients with allergic rhinitis. We have previously shown that placing the substance that subjects are allergic to in their nose causes both nose and eye symptoms. This can be explain by a parasympathetic neurogenic reflex from the nose to the eye. Such a reflex would readily explain the tearing and watery eye symptoms, but does not explain the itch. In this study, we are going to address one possible explanation for the itch; does an axonal neurogenic reflex stimulate mast cells in the eye to release histamine, which then causes the itch? We will do this by placing an antihistamine drop in the eye and challenge the nose with allergen. We will also attempt to demonstrate that mast activation isn't effected by blocking the initiating of the reflex with a nasal steroid, as done in our previous study, and showing that the addition of an antihistamine does not add to the reduction of symptoms.
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 2009
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, 2009
CompletedFirst Submitted
Initial submission to the registry
November 3, 2009
CompletedFirst Posted
Study publicly available on registry
November 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
July 17, 2013
CompletedJuly 17, 2013
June 1, 2013
5 months
November 3, 2009
March 26, 2013
June 12, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Total Eye Symptoms Score Difference
After treatment, each participant was subjected to a diluent (control) challenge in one eye and was asked to rate 2 eye symptoms (watery and itchy) according to the following scale: 0=none, 1=mild, 2=moderate, 3=severe. The participant was then exposed to 3 doses of an antigen challenge and was asked to similarly rate severity of watery and itchy eye symptoms after each dose. Diluent challenge scores were subtracted from the scores recorded after each dose. This process was repeated in the other eye. The outcome is the total of the score differences (i.e. score after each dose subtracted by diluent challenge score) summed across doses, symptoms (watery and itchy), and eyes (left and right). Thus, each participant's total score is an integer value ranging from -36 to 36.
50 minutes [duration of 3 nasal challenges and 2 washout periods]
Secondary Outcomes (5)
Total Nasal Symptoms Score Difference
50 minutes [duration of 3 nasal challenges and 2 washout periods]
Total Number of Sneezes
50 minutes [duration of 3 nasal challenges and 2 washout periods]
Change in Histamine Level (Across Nasal Challenges)
50 minutes [duration of 3 nasal challenges and 2 washout periods]
Change in Tryptase Level (Across Nasal Challenges)
50 minutes [duration of 3 nasal challenges and 2 washout periods]
Total Number of Eosinophils
50 minutes [duration of 3 nasal challenges and 2 washout periods]
Study Arms (4)
FF/PL, PL/OLO, FF/OLO, PL/PL
OTHEREach subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order: * fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL) * PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO), * FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO), and * placebo (PL) nasal spray and PL eye drops (PL/PL).
PL/OLO, FF/OLO, PL/PL, FF/PL
OTHEREach subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order: * PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO), * FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO), * placebo (PL) nasal spray and PL eye drops (PL/PL), and * fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL).
FF/OLO, PL/PL, FF/PL, PL/OLO
OTHEREach subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order: * FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO), * placebo (PL) nasal spray and PL eye drops (PL/PL), * fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL), and * PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO).
PL/PL, FF/PL, PL/OLO, FF/OLO
OTHEREach subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order: * placebo (PL) nasal spray and PL eye drops (PL/PL), * fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL), * PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO), and * FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO).
Interventions
2 puffs of PL nasal spray (from GlaxoSmithKline) in each nostril once a day for 1 week
2 puffs of FF nasal spray in each nostril once a day for 1 week
1 drop of placebo eye drops (lubricant eye drops with active ingredients 0.3% glycerin) in each eye once a day for 1 week
1 drop of OLO eye drops in each eye once a day 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.
- forced expiratory volume at one second (FEV1) \<80% of predicted at screening for subjects with history of mild asthma.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Chicagolead
- GlaxoSmithKlinecollaborator
Study Sites (1)
The University of Chicago
Chicago, Illinois, 60637, United States
Related Publications (1)
Baroody FM, Logothetis H, Vishwanath S, Bashir M, Detineo M, Naclerio RM. Effect of intranasal fluticasone furoate and intraocular olopatadine on nasal and ocular allergen-induced symptoms. Am J Rhinol Allergy. 2013 Jan;27(1):48-53. doi: 10.2500/ajra.2013.27.3841.
PMID: 23406601RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Robert M. Naclerio, MD
- Organization
- The University of Chicago
Study Officials
- PRINCIPAL INVESTIGATOR
Robert M Naclerio, MD
University of Chicago
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
November 3, 2009
First Posted
November 4, 2009
Study Start
November 1, 2009
Primary Completion
April 1, 2010
Study Completion
August 1, 2011
Last Updated
July 17, 2013
Results First Posted
July 17, 2013
Record last verified: 2013-06