NCT00117832

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 8, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

September 5, 2013

Status Verified

September 1, 2013

Enrollment Period

1.2 years

First QC Date

June 30, 2005

Last Update Submit

September 4, 2013

Conditions

Keywords

allergic rhinitis

Outcome Measures

Primary Outcomes (1)

  • Amount of eye secretions collected on Schirmer strips following antigen challenge

Secondary Outcomes (1)

  • Amount of eye secretions collected on Schirmer strips following antigen challenge

Interventions

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • History of grass and/or ragweed allergic rhinitis.
  • Positive skin test to grass and/or ragweed antigen.
  • Positive response to screening nasal challenge.

You may not qualify if:

  • Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
  • Pregnant or lactating women.
  • Upper respiratory infection within 14 days of study start.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (39)

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    PMID: 14579656BACKGROUND
  • 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.

    PMID: 12866325BACKGROUND
  • 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.

    PMID: 12602669BACKGROUND
  • 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.

    PMID: 12086367BACKGROUND
  • 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.

    PMID: 12002729BACKGROUND
  • 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.

    PMID: 11350300BACKGROUND
  • 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.

    PMID: 10856142BACKGROUND
  • 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.

    PMID: 10848909BACKGROUND
  • 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.

    PMID: 10808172BACKGROUND
  • 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.

    PMID: 9927957BACKGROUND
  • 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.

    PMID: 10070173BACKGROUND
  • 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.

    PMID: 9292184BACKGROUND
  • 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.

    PMID: 8739863BACKGROUND
  • 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.

    PMID: 8607560BACKGROUND
  • 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.

    PMID: 7614525BACKGROUND
  • 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.

    PMID: 7889428BACKGROUND
  • 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.

    PMID: 8039024BACKGROUND
  • 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.

    PMID: 8179230BACKGROUND
  • 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.

    PMID: 8368459BACKGROUND
  • 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.

    PMID: 1685945BACKGROUND
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    PMID: 3087656BACKGROUND
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  • 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.

MeSH Terms

Conditions

Rhinitis, Allergic, SeasonalRhinitis, Allergic

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Robert M Naclerio, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 8, 2005

Study Start

March 1, 2005

Primary Completion

May 1, 2006

Study Completion

October 1, 2006

Last Updated

September 5, 2013

Record last verified: 2013-09

Locations