NCT01007253|CompletedPhase 4Results
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Sponsor study identifier
interventional
21
1 country
1
Study Start
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2010
Actual (reported)Study Completion
August 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2011
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
November 3, 2009
Actual (reported)November 4, 2009
Actual (reported)April 2010
Actual (reported)August 2011
Actual (reported)July 17, 2013
Actual (reported)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]
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]
Each 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).
Each 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).
2 puffs of PL nasal spray (from GlaxoSmithKline) in each nostril once a day for 1 week
The University of Chicago
Chicago, Illinois, 60637, United States
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.
Robert M Naclerio, MD
University of Chicago
21 participants (actual enrollment reported by the registry).
First Submitted
November 3, 2009
First Posted
November 4, 2009
Study Start
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
Comparison of Seasonal Allergic Rhinitis Treatment With 2 Antihistamines Used in Combination With Intranasal Corticosteroid
Each 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).
Each 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).
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
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Primary Completion
April 2010
Actual (reported)Study Completion
August 2011
Actual (reported)Last Updated
July 17, 2013
Results First Posted
July 17, 2013
Record last verified: 2013-06
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