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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
University of Chicago
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Rhinitis, Allergic, Seasonal focused on measuring allergic rhinitis

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

First Posted
June 30, 2005
Last Updated
September 4, 2013
Sponsor
University of Chicago
Collaborators
GlaxoSmithKline
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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

Citations:
PubMed Identifier
15462688
Citation
Philip G, Nayak AS, Berger WE, Leynadier F, Vrijens F, Dass SB, Reiss TF. The effect of montelukast on rhinitis symptoms in patients with asthma and seasonal allergic rhinitis. Curr Med Res Opin. 2004 Oct;20(10):1549-58. doi: 10.1185/030079904x3348.
Results Reference
background
PubMed Identifier
12452206
Citation
Yanez A, Rodrigo GJ. Intranasal corticosteroids versus topical H1 receptor antagonists for the treatment of allergic rhinitis: a systematic review with meta-analysis. Ann Allergy Asthma Immunol. 2002 Nov;89(5):479-84. doi: 10.1016/S1081-1206(10)62085-6.
Results Reference
background
PubMed Identifier
15281472
Citation
Gray RD, Haggart K, Lee DK, Cull S, Lipworth BJ. Effects of butterbur treatment in intermittent allergic rhinitis: a placebo-controlled evaluation. Ann Allergy Asthma Immunol. 2004 Jul;93(1):56-60. doi: 10.1016/S1081-1206(10)61447-0.
Results Reference
background
PubMed Identifier
15160443
Citation
Hampel F Jr, Howland W 3rd, Van Bavel J, Ratner P. A randomized, double-blind, placebo-controlled study comparing the efficacy and safety of ebastine (20 mg and 10 mg) to loratadine 10 mg once daily in the treatment of seasonal allergic rhinitis. J Investig Allergol Clin Immunol. 2004;14(1):56-63.
Results Reference
background
PubMed Identifier
15237767
Citation
Shahar E, Hassoun G, Pollack S. Effect of vitamin E supplementation on the regular treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2004 Jun;92(6):654-8. doi: 10.1016/S1081-1206(10)61432-9.
Results Reference
background
PubMed Identifier
14616102
Citation
van Adelsberg J, Philip G, Pedinoff AJ, Meltzer EO, Ratner PH, Menten J, Reiss TF; Montelukast Fall Rhinitis Study Group. Montelukast improves symptoms of seasonal allergic rhinitis over a 4-week treatment period. Allergy. 2003 Dec;58(12):1268-76. doi: 10.1046/j.1398-9995.2003.00261.x. Erratum In: Allergy. 2004 Mar;59(3):357. Allergy. 2009 Nov;64(11):1697.
Results Reference
background
PubMed Identifier
14971719
Citation
Remberg P, Bjork L, Hedner T, Sterner O. Characteristics, clinical effect profile and tolerability of a nasal spray preparation of Artemisia abrotanum L. for allergic rhinitis. Phytomedicine. 2004 Jan;11(1):36-42. doi: 10.1078/0944-7113-00350.
Results Reference
background
PubMed Identifier
14579656
Citation
Kirchhoff CH, Kremer B, Haaf-von Below S, Kyrein HJ, Mosges R. Effects of dimethindene maleate nasal spray on the quality of life in seasonal allergic rhinitis. Rhinology. 2003 Sep;41(3):159-66.
Results Reference
background
PubMed Identifier
12866325
Citation
Lumry W, Hampel F, LaForce C, Kiechel F, el-Akkad T, Murray JJ. A comparison of once-daily triamcinolone acetonide aqueous and twice-daily beclomethasone dipropionate aqueous nasal sprays in the treatment of seasonal allergic rhinitis. Allergy Asthma Proc. 2003 May-Jun;24(3):203-10.
Results Reference
background
PubMed Identifier
12602669
Citation
van Adelsberg J, Philip G, LaForce CF, Weinstein SF, Menten J, Malice MP, Reiss TF; Montelukast Spring Rhinitis Investigator Group. Randomized controlled trial evaluating the clinical benefit of montelukast for treating spring seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2003 Feb;90(2):214-22. doi: 10.1016/S1081-1206(10)62144-8.
Results Reference
background
PubMed Identifier
12086367
Citation
Nayak AS, Philip G, Lu S, Malice MP, Reiss TF; Montelukast Fall Rhinitis Investigator Group. Efficacy and tolerability of montelukast alone or in combination with loratadine in seasonal allergic rhinitis: a multicenter, randomized, double-blind, placebo-controlled trial performed in the fall. Ann Allergy Asthma Immunol. 2002 Jun;88(6):592-600. doi: 10.1016/S1081-1206(10)61891-1.
Results Reference
background
PubMed Identifier
12002729
Citation
Wilson AM, Orr LC, Coutie WJ, Sims EJ, Lipworth BJ. A comparison of once daily fexofenadine versus the combination of montelukast plus loratadine on domiciliary nasal peak flow and symptoms in seasonal allergic rhinitis. Clin Exp Allergy. 2002 Jan;32(1):126-32. doi: 10.1046/j.0022-0477.2001.01252.x.
Results Reference
background
PubMed Identifier
11350300
Citation
Kilpelainen M, Terho EO, Helenius H, Koskenvuo M. Validation of a new questionnaire on asthma, allergic rhinitis, and conjunctivitis in young adults. Allergy. 2001 May;56(5):377-84. doi: 10.1034/j.1398-9995.2001.056005377.x.
Results Reference
background
PubMed Identifier
10856142
Citation
Ratner PH, Lim JC, Georges GC. Comparison of once-daily ebastine 20 mg, ebastine 10 mg, loratadine 10 mg, and placebo in the treatment of seasonal allergic rhinitis. The Ebastine Study Group. J Allergy Clin Immunol. 2000 Jun;105(6 Pt 1):1101-7. doi: 10.1067/mai.2000.105525.
Results Reference
background
PubMed Identifier
10848909
Citation
Van Cauwenberge P, Juniper EF. Comparison of the efficacy, safety and quality of life provided by fexofenadine hydrochloride 120 mg, loratadine 10 mg and placebo administered once daily for the treatment of seasonal allergic rhinitis. Clin Exp Allergy. 2000 Jun;30(6):891-9. doi: 10.1046/j.1365-2222.2000.00914.x.
Results Reference
background
PubMed Identifier
10808172
Citation
Meltzer EO, Malmstrom K, Lu S, Prenner BM, Wei LX, Weinstein SF, Wolfe JD, Reiss TF. Concomitant montelukast and loratadine as treatment for seasonal allergic rhinitis: a randomized, placebo-controlled clinical trial. J Allergy Clin Immunol. 2000 May;105(5):917-22. doi: 10.1067/mai.2000.106040.
Results Reference
background
PubMed Identifier
9927957
Citation
Hadley JA. Evaluation and management of allergic rhinitis. Med Clin North Am. 1999 Jan;83(1):13-25. doi: 10.1016/s0025-7125(05)70084-5.
Results Reference
background
PubMed Identifier
10070173
Citation
Yang WH, Dolovich J, Drouin MA, Keith P, Haddon J, Jennings B. Comparison of budesonide Turbuhaler with budesonide aqua in the treatment of seasonal allergic rhinitis. Rhinocort Study Group. Can Respir J. 1998 Nov-Dec;5(6):455-60. doi: 10.1155/1998/639710.
Results Reference
background
PubMed Identifier
9292184
Citation
Stern MA, Dahl R, Nielsen LP, Pedersen B, Schrewelius C. A comparison of aqueous suspensions of budesonide nasal spray (128 micrograms and 256 micrograms once daily) and fluticasone propionate nasal spray (200 micrograms once daily) in the treatment of adult patients with seasonal allergic rhinitis. Am J Rhinol. 1997 Jul-Aug;11(4):323-30. doi: 10.2500/105065897781446658.
Results Reference
background
PubMed Identifier
8739863
Citation
Simola M, Boss I, Holopainen E, Malmberg H, Ruoppi P, Seppa J, Siivonen L, Suonpaa J, Piepponen T. Astemizole in combination with pseudoephedrine in the treatment of seasonal allergic rhinitis. Rhinology. 1996 Mar;34(1):21-3.
Results Reference
background
PubMed Identifier
8607560
Citation
Pedersen B, Dahl R, Richards DH, Jacques LA, Larsen BB, Pichler W, Nykanen KN. Once daily fluticasone propionate aqueous nasal spray controls symptoms of most patients with seasonal allergic rhinitis. Allergy. 1995 Oct;50(10):794-9. doi: 10.1111/j.1398-9995.1995.tb05051.x.
Results Reference
background
PubMed Identifier
7614525
Citation
Settipane G, Korenblat PE, Winder J, Lumry W, Murphree J, Alderfer VB, Simpson B, Smith JA. Triamcinolone acetonide Aqueous nasal spray in patients with seasonal ragweed allergic rhinitis: a placebo-controlled, double-blind study. Clin Ther. 1995 Mar-Apr;17(2):252-63. doi: 10.1016/0149-2918(95)80023-9.
Results Reference
background
PubMed Identifier
7889428
Citation
Darnell R, Pecoud A, Richards DH. A double-blind comparison of fluticasone propionate aqueous nasal spray, terfenadine tablets and placebo in the treatment of patients with seasonal allergic rhinitis to grass pollen. Clin Exp Allergy. 1994 Dec;24(12):1144-50. doi: 10.1111/j.1365-2222.1994.tb03320.x.
Results Reference
background
PubMed Identifier
8039024
Citation
Loth S, Bende M. Effect of nasal anaesthesia on lacrimal function after nasal allergen challenge. Clin Exp Allergy. 1994 Apr;24(4):375-6. doi: 10.1111/j.1365-2222.1994.tb00249.x.
Results Reference
background
PubMed Identifier
8179230
Citation
Dolovich J, O'Connor M, Stepner N, Smith A, Sharma RK. Double-blind comparison of intranasal fluticasone propionate, 200 micrograms, once daily with 200 micrograms twice daily in the treatment of patients with severe seasonal allergic rhinitis to ragweed. Ann Allergy. 1994 May;72(5):435-40.
Results Reference
background
PubMed Identifier
8368459
Citation
Bousquet J, Chanal I, Alquie MC, Charpin D, Didier A, Germouty J, Greillier P, Ickovic MH, Maria Y, Montane F, et al. Prevention of pollen rhinitis symptoms: comparison of fluticasone propionate aqueous nasal spray and disodium cromoglycate aqueous nasal spray. A multicenter, double-blind, double-dummy, parallel-group study. Allergy. 1993 Jul;48(5):327-33. doi: 10.1111/j.1398-9995.1993.tb02401.x.
Results Reference
background
PubMed Identifier
1685945
Citation
Frolund L. Efficacy of an oral antihistamine, loratadine, as compared with a nasal steroid spray, beclomethasone dipropionate, in seasonal allergic rhinitis. Clin Otolaryngol Allied Sci. 1991 Dec;16(6):527-31. doi: 10.1111/j.1365-2273.1991.tb00965.x.
Results Reference
background
PubMed Identifier
2212409
Citation
Juniper EF, Guyatt GH, O'Byrne PM, Viveiros M. Aqueous beclomethasone diproprionate nasal spray: regular versus "as required" use in the treatment of seasonal allergic rhinitis. J Allergy Clin Immunol. 1990 Sep;86(3 Pt 1):380-6. doi: 10.1016/s0091-6749(05)80101-0.
Results Reference
background
PubMed Identifier
2143361
Citation
Frolund L, Etholm B, Irander K, Johannessen TA, Odkvist L, Ohlander B, Weeke B. A multicentre study of loratadine, clemastine and placebo in patients with perennial allergic rhinitis. Allergy. 1990 May;45(4):254-61. doi: 10.1111/j.1398-9995.1990.tb00493.x.
Results Reference
background
PubMed Identifier
2883715
Citation
Johansen LV, Bjerrum P, Illum P. Treatment of seasonal allergic rhinitis--a double blind, group comparative study of terfenadine and dexchlorpheniramine. Rhinology. 1987 Mar;25(1):35-40.
Results Reference
background
PubMed Identifier
3551670
Citation
Borum P, Gronborg H, Mygind N. Seasonal allergic rhinitis and depot injection of a corticosteroid. Evaluation of the efficacy of medication early and late in the season based on detailed symptom recording. Allergy. 1987 Jan;42(1):26-32. doi: 10.1111/j.1398-9995.1987.tb02183.x.
Results Reference
background
PubMed Identifier
3087656
Citation
Wood SF. Oral antihistamine or nasal steroid in hay fever: a double-blind double-dummy comparative study of once daily oral astemizole vs twice daily nasal beclomethasone dipropionate. Clin Allergy. 1986 May;16(3):195-201. doi: 10.1111/j.1365-2222.1986.tb00766.x.
Results Reference
background
PubMed Identifier
3711553
Citation
Orgel HA, Meltzer EO, Kemp JP, Welch MJ. Clinical, rhinomanometric, and cytologic evaluation of seasonal allergic rhinitis treated with beclomethasone dipropionate as aqueous nasal spray or pressurized aerosol. J Allergy Clin Immunol. 1986 Jun;77(6):858-64. doi: 10.1016/0091-6749(86)90384-2.
Results Reference
background
PubMed Identifier
3082694
Citation
Backhouse CI, Finnamore VP, Gosden CW. Treatment of seasonal allergic rhinitis with flunisolide and terfenadine. J Int Med Res. 1986;14(1):35-41.
Results Reference
background
PubMed Identifier
2863090
Citation
Beswick KB, Kenyon GS, Cherry JR. A comparative study of beclomethasone dipropionate aqueous nasal spray with terfenadine tablets in seasonal allergic rhinitis. Curr Med Res Opin. 1985;9(8):560-7. doi: 10.1185/03007998509109635.
Results Reference
background
PubMed Identifier
365920
Citation
Schaaf L, Hendeles L, Weinberger M. Suppression of seasonal allergic rhinitis symptoms with daily hydroxyzine. J Allergy Clin Immunol. 1979 Feb;63(2):129-33. doi: 10.1016/0091-6749(79)90203-3.
Results Reference
background
PubMed Identifier
782679
Citation
Cockcroft DW, MacCormack DW, Newhouse MT, Hargreave FE. Beclomethasone dipropionate aerosol in allergic rhinitis. Can Med Assoc J. 1976 Sep 18;115(6):523-6.
Results Reference
background
PubMed Identifier
1106108
Citation
Lofkvist T, Svensson G. An open assessment of becotide (beclomethasone dipropionate) nasal spray in seasonal allergic rhinitis. Acta Allergol. 1975 Oct;30(4):227-38. doi: 10.1111/j.1398-9995.1975.tb01345.x.
Results Reference
background
PubMed Identifier
18426137
Citation
Baroody FM, Foster KA, Markaryan A, deTineo M, Naclerio RM. Nasal ocular reflexes and eye symptoms in patients with allergic rhinitis. Ann Allergy Asthma Immunol. 2008 Mar;100(3):194-9. doi: 10.1016/S1081-1206(10)60442-5.
Results Reference
derived

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Nasal Ocular Reflexes Contribute to Eye Symptoms

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