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
About this trial
This is an interventional basic science trial for Seasonal Allergic Rhinitis
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
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
NCT ID
NCT00755066
First Posted
September 17, 2008
Last Updated
September 25, 2008
Sponsor
Medical University of Vienna
Collaborators
Allergy Centre Vienna West
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
derived
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Effect of Intranasal Corticosteroids on Systemic Allergen Specific IgE
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