Nasal Ocular Reflexes Contribute to Eye Symptoms
Primary Purpose
Rhinitis, Allergic, Seasonal
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Azelastine nasal spray
Sponsored by
About this trial
This is an interventional diagnostic trial for Rhinitis, Allergic, Seasonal focused on measuring allergic rhinitis
Eligibility Criteria
Inclusion Criteria: History of grass and/or ragweed allergic rhinitis. Positive skin test to grass and/or ragweed antigen. Positive response to screening nasal challenge. Exclusion Criteria: Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease. Pregnant or lactating women. Upper respiratory infection within 14 days of study start.
Sites / Locations
- University of Chicago
Outcomes
Primary Outcome Measures
Amount of eye secretions collected on Schirmer strips following antigen challenge
Secondary Outcome Measures
Amount of eye secretions collected on Schirmer strips following antigen challenge
Full Information
NCT ID
NCT00117832
First Posted
June 30, 2005
Last Updated
September 4, 2013
Sponsor
University of Chicago
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00117832
Brief Title
Nasal Ocular Reflexes Contribute to Eye Symptoms
Official Title
Nasal Ocular Reflexes Contribute to Eye Symptoms in Patients With Allergic Rhinitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
October 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Eye symptoms of tearing, redness and itching frequently occur in patients with allergic rhinitis or hayfever. The purpose of this trial is to study whether placing an allergen (a substance that causes allergies) directly in your nose can cause you to have eye symptoms as well as nasal symptoms.
Detailed Description
Symptoms of conjunctivitis (tearing, redness and itching) frequently occur in patients with allergic rhinitis. The pathophysiology underlying these symptoms remains to be elucidated. The symptoms probably arise via a combination of mechanisms including direct contact of natural pollen with the conjunctiva and reflex mechanisms originating in the nose.
Pollen exposure can result from direct hand transfer of pollen to the conjunctiva or, conceivably, from the forceful blowing of air, containing nasal secretions with antigen, up the nasolacrimal duct. The latter mechanism would be considered extremely unlikely because of the location of the nasolacrimal duct under the inferior turbinate (the duct's location is in an area with little pollen exposure) and the considerable force of air needed to cause reverse flow in the duct. The latter would also be true for topically applied intranasal drugs reaching the conjunctiva via the nasolacrimal duct, whereas the administration of medications to the conjunctiva frequently results in these medications reaching the nose via the nasolacrimal duct.
In support of direct contact of pollen as a source of ocular symptoms in patients with allergic rhinitis is the observation that pollen can be washed out of the conjunctiva on windy days, although the amount is 10 fold less than the amount of pollen recovered simultaneously from the nose. Additionally, beginning with Noon in the early 1900s, and subsequently shown by others, direct conjunctival challenges induce ocular symptoms. Thus, direct contact is a plausible explanation, but its relative contribution to eye symptoms in allergic rhinitis is unknown. Since topical intranasal steroids are known to reduce eye symptoms and the chance of them reaching the eye by systemic absorption or directly when administered intranasally are very slim, the investigators would postulate that direct allergen contact at the conjunctiva is a small contributor to the overall ocular symptom complex.
Reflex mechanisms within the nose have been shown to occur universally in response to nasal challenge with antigen. Nasal challenge with antigen induces a reflex in the contralateral nasal cavity, known as the nasonasal reflex. This reflex can also be initiated by nasal challenge with cold, dry air and histamine. The contralateral response to antigen, cold dry air and histamine is blocked by topical anticholinergic agents applied to the contralateral side, suggesting that the efferent limb is parasympathetically mediated. Histamine is only released on the side of challenge with antigen but oral H1 antihistamines reduce the contralateral response to unilateral nasal allergen challenge, suggesting that histamine contributes to the initiation of the reflex. The eye is richly innervated by parasympathetic nerves which enter the eye after running in conjunction with the parasympathetic input to the nasal cavity. The investigators, therefore, hypothesize that the conjunctiva will respond to nasal allergen in a manner similar to the contralateral nasal cavity.
Purpose: The investigators will study whether antigen-induced nasal reflexes cause eye symptoms. The investigators suspect that reflexes occur between the nose and the eye, and contribute substantially to eye symptoms in allergic patients during the allergy season. The investigators propose to demonstrate that nasal challenge with antigen leads to increased lacrimation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Seasonal
Keywords
allergic rhinitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Azelastine nasal spray
Primary Outcome Measure Information:
Title
Amount of eye secretions collected on Schirmer strips following antigen challenge
Secondary Outcome Measure Information:
Title
Amount of eye secretions collected on Schirmer strips following antigen challenge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
History of grass and/or ragweed allergic rhinitis.
Positive skin test to grass and/or ragweed antigen.
Positive response to screening nasal challenge.
Exclusion Criteria:
Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
Pregnant or lactating women.
Upper respiratory infection within 14 days of study start.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert M Naclerio, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
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Nasal Ocular Reflexes Contribute to Eye Symptoms
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