Ignite Creation Date:
2024-05-05 @ 10:00 PM
Last Modification Date:
2024-10-26 @ 10:12 AM
Study NCT ID:
NCT01007253
Status:
COMPLETED
Last Update Posted:
2013-07-17
First Post:
2009-11-03
Brief Title:
Effect of Veramyst and Olopatadine 02 Opthalmic Solution on Allergy Symptoms
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Effect of Veramyst and Olopatadine 02 Opthalmic Solution Alone and In Combination on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 isnt 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
Detailed Description:
We performed a randomized double-blind double-dummy placebo-controlled four-way crossover study in 21 subjects with seasonal allergic rhinitis studied out of season Healthy patients between 18 and 50 years of age came to the Nasal Physiology Laboratory at The University of Chicago for screening where they completed an allergy questionnaire and underwent skin puncture testing for confirmation of allergy to grass or ragweed Female subjects were given pregnancy tests Patients who were eligible then underwent a screening nasal challenge with either grass or ragweed allergen depending on their skin test results and history The study was approved by the Institutional Review Board at The University of Chicago and all of the patients gave written informed consent before entry
After a 2-week washout period after the screening challenge 21 subjects who had positive screening challenge returned to the Nasal Physiology Laboratory where they were randomized to receive 1 week of one of four treatments
placebo PL nasal spray and PL eye drops PLPL
PL nasal spray and olopatadine OLO 02 ophthalmic solution PLOLO
fluticasone furoate FF also known as Veramyst nasal spray and PL eye drops FFPL and
FF nasal spray and olopatadine OLO 02 ophthalmic solution FFOLO
Specifically the PL eye drops used were lubricant eye drops with active ingredients of 03 glycerin and 10 propylene glycol and the PL nasal spray was provided by GlaxoSmithKline Treatment with OLO consisted of 1 drop of 02 OLO in each eye daily and treatment of FF consisted of 2 puffs in each nostril daily giving a total of 110 micrograms delivered in each nostril After a week of each of the treatments the subjects returned to the Nasal Physiology Laboratory to undergo a nasal challenge The subjects then returned the next day while still receiving treatment for another nasal challenge to augment the nasal ocular reflex Next the patients had a 2-week washout period and then switched over to the next randomized treatment arm This sequence was repeated until subjects completed all four arms of the trial
After a 2-week washout period after the screening challenge 21 subjects who had positive screening challenge returned to the Nasal Physiology Laboratory where they were randomized to receive 1 week of one of four treatments
placebo PL nasal spray and PL eye drops PLPL
PL nasal spray and olopatadine OLO 02 ophthalmic solution PLOLO
fluticasone furoate FF also known as Veramyst nasal spray and PL eye drops FFPL and
FF nasal spray and olopatadine OLO 02 ophthalmic solution FFOLO
Specifically the PL eye drops used were lubricant eye drops with active ingredients of 03 glycerin and 10 propylene glycol and the PL nasal spray was provided by GlaxoSmithKline Treatment with OLO consisted of 1 drop of 02 OLO in each eye daily and treatment of FF consisted of 2 puffs in each nostril daily giving a total of 110 micrograms delivered in each nostril After a week of each of the treatments the subjects returned to the Nasal Physiology Laboratory to undergo a nasal challenge The subjects then returned the next day while still receiving treatment for another nasal challenge to augment the nasal ocular reflex Next the patients had a 2-week washout period and then switched over to the next randomized treatment arm This sequence was repeated until subjects completed all four arms of the trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None