CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 21 enrolled
Drug / intervention
PL nasal spray +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01007253
NCT01007253Phase 4Completed

Effect of Veramyst and Olopatadine 0.2% Opthalmic Solution Alone and In Combination on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen.

University of Chicago·interventional·Posted Nov 4, 2009·Updated Jul 17, 2013

In Brief

A Phase 4 clinical trial evaluating PL nasal spray, fluticasone furoate (FF), and 2 other interventions for Seasonal Allergic Rhinitis. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsGlaxoSmithKline

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 4, 2009
Enrollment StartNov 1, 2009
Primary CompletionApr 1, 2010
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 16.7 years ago

Interventions

PL nasal spraydrug

2 puffs of PL nasal spray (from GlaxoSmithKline) in each nostril once a day for 1 week

fluticasone furoate (FF)drug

2 puffs of FF nasal spray in each nostril once a day for 1 week

PL eye dropsdrug

1 drop of placebo eye drops (lubricant eye drops with active ingredients 0.3% glycerin) in each eye once a day for 1 week

olopatadine (OLO)drug

1 drop of OLO eye drops in each eye once a day for 1 week