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Effect of Intranasal Corticosteroids on Systemic Allergen Specific IgE

Primary Purpose

Seasonal Allergic Rhinitis

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Fluticasone propionate
Placebo
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Seasonal Allergic Rhinitis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • male or female 18-50 years of age
  • moderate to severe allergic rhinitis to grass and/or birch pollen for at least two seasons according to history
  • sensitization to rPhl p 5 and rBet v 1 as demonstrated by UniCAP within a range from 3.0-80 kUA/l and a positive (wheal diameter >= 3 mm larger than the negative control and half of the histamine control) SPT with rPhl p 5 and rBet v 1 at 20 µg/ml
  • willingness to comply with the study protocol
  • written informed consent

Exclusion Criteria:

  • perennial allergic rhinitis
  • history of asthma necessitating treatment
  • FEV1 <70% of predicted value
  • abnormalities at auscultation of heart or lungs
  • history of anaphylaxis
  • severe atopic dermatitis
  • total serum IgE >2000 kU/l
  • previous or ongoing immunotherapy (subcutaneous or sublingual) to grass or birch pollen
  • nasal provocation testing during the previous six month
  • known allergy/intolerance to fluticasone propionate or loratadine
  • known allergy/intolerance to cellulose, polysorbate, phenylethyl alcohol, benzalkonium chloride
  • contraindications for the use of INCS:
  • acute or chronic infections of the upper respiratory tract
  • surgery of the nose during the previous year
  • hypersensitivity to components of the drug
  • contraindications for nasal provocation test
  • acute rhinosinusitis
  • acute allergic reaction of the immediate type at other organs
  • nasal polyposis or significant nasal anatomical deformities
  • vasomotor rhinitis
  • autoimmune disease, chronic or acute infectious disease, malignancy
  • severe psychological disorder
  • treatment with systemic or topical (intranasal, inhaled, external) corticosteroids from 3 month prior to the study
  • treatment with other immunosuppressant drugs from 6 month prior to the study
  • treatment with antihistamines or disodium cromoglycate from 2 weeks prior to the study
  • treatment with intranasal adrenergic drugs from 3 days prior to the study
  • treatment with systemic adrenergic drugs
  • treatment with psychopharmacological drugs from 2 weeks prior to the study
  • cardiovascular or pulmonary disease
  • contraindication for adrenaline
  • participation in any other clinical trial within the previous 3 month
  • pregnant, lactating or sexually active women with childbearing potential who are not using a medically accepted birth control method
  • a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude
  • known alcohol or drug addiction or abuse
  • unlikelihood to be able to complete the study

Sites / Locations

  • Allergy Centre Vienna West

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

F

P

Arm Description

Fluticasone propionate 200 µg intranasal

Placebo intranasal spray

Outcomes

Primary Outcome Measures

Allergen specific IgE levels

Secondary Outcome Measures

Allergen specific IgG 1-4, IgM, IgA levels

Full Information

First Posted
September 17, 2008
Last Updated
September 25, 2008
Sponsor
Medical University of Vienna
Collaborators
Allergy Centre Vienna West
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1. Study Identification

Unique Protocol Identification Number
NCT00755066
Brief Title
Effect of Intranasal Corticosteroids on Systemic Allergen Specific IgE
Official Title
The Effect of Intranasal Corticosteroid on the Immune Response Following Nasal Allergen Challenge in Patients Suffering From Seasonal Allergic Rhinitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Vienna
Collaborators
Allergy Centre Vienna West

4. Oversight

5. Study Description

Brief Summary
Evaluation of the effect of fluticasone propionate vs placebo applied as nasal spray on the increase of allergen-specific serum IgE levels following nasal exposure to recombinant allergens. Nasal sprays will be applied for four weeks starting two weeks before nasal provocation and serum IgE levels will be followed during eight weeks after nasal provocation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
F
Arm Type
Experimental
Arm Description
Fluticasone propionate 200 µg intranasal
Arm Title
P
Arm Type
Placebo Comparator
Arm Description
Placebo intranasal spray
Intervention Type
Drug
Intervention Name(s)
Fluticasone propionate
Intervention Description
200 µg intranasal, 4 weeks, od.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo intranasal spray
Primary Outcome Measure Information:
Title
Allergen specific IgE levels
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Allergen specific IgG 1-4, IgM, IgA levels
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: male or female 18-50 years of age moderate to severe allergic rhinitis to grass and/or birch pollen for at least two seasons according to history sensitization to rPhl p 5 and rBet v 1 as demonstrated by UniCAP within a range from 3.0-80 kUA/l and a positive (wheal diameter >= 3 mm larger than the negative control and half of the histamine control) SPT with rPhl p 5 and rBet v 1 at 20 µg/ml willingness to comply with the study protocol written informed consent Exclusion Criteria: perennial allergic rhinitis history of asthma necessitating treatment FEV1 <70% of predicted value abnormalities at auscultation of heart or lungs history of anaphylaxis severe atopic dermatitis total serum IgE >2000 kU/l previous or ongoing immunotherapy (subcutaneous or sublingual) to grass or birch pollen nasal provocation testing during the previous six month known allergy/intolerance to fluticasone propionate or loratadine known allergy/intolerance to cellulose, polysorbate, phenylethyl alcohol, benzalkonium chloride contraindications for the use of INCS: acute or chronic infections of the upper respiratory tract surgery of the nose during the previous year hypersensitivity to components of the drug contraindications for nasal provocation test acute rhinosinusitis acute allergic reaction of the immediate type at other organs nasal polyposis or significant nasal anatomical deformities vasomotor rhinitis autoimmune disease, chronic or acute infectious disease, malignancy severe psychological disorder treatment with systemic or topical (intranasal, inhaled, external) corticosteroids from 3 month prior to the study treatment with other immunosuppressant drugs from 6 month prior to the study treatment with antihistamines or disodium cromoglycate from 2 weeks prior to the study treatment with intranasal adrenergic drugs from 3 days prior to the study treatment with systemic adrenergic drugs treatment with psychopharmacological drugs from 2 weeks prior to the study cardiovascular or pulmonary disease contraindication for adrenaline participation in any other clinical trial within the previous 3 month pregnant, lactating or sexually active women with childbearing potential who are not using a medically accepted birth control method a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude known alcohol or drug addiction or abuse unlikelihood to be able to complete the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Friedrich Horak, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergy Centre Vienna West
City
Vienna
ZIP/Postal Code
1150
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
25705889
Citation
Egger C, Lupinek C, Ristl R, Lemell P, Horak F, Zieglmayer P, Spitzauer S, Valenta R, Niederberger V. Effects of nasal corticosteroids on boosts of systemic allergen-specific IgE production induced by nasal allergen exposure. PLoS One. 2015 Feb 23;10(2):e0114991. doi: 10.1371/journal.pone.0114991. eCollection 2015.
Results Reference
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Effect of Intranasal Corticosteroids on Systemic Allergen Specific IgE

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