Effect of Intranasal Corticosteroids on Systemic Allergen Specific IgE
NCT ID: NCT00755066
Last Updated: 2008-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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F
Fluticasone propionate 200 µg intranasal
Fluticasone propionate
200 µg intranasal, 4 weeks, od.
P
Placebo intranasal spray
Placebo
Placebo intranasal spray
Interventions
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Fluticasone propionate
200 µg intranasal, 4 weeks, od.
Placebo
Placebo intranasal spray
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
ALL
No
Sponsors
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Allergy Centre Vienna West
OTHER
Medical University of Vienna
OTHER
Principal Investigators
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Friedrich Horak, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Locations
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Allergy Centre Vienna West
Vienna, , Austria
Countries
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References
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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.
Other Identifiers
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EudraCT 2005-004274-24
Identifier Type: -
Identifier Source: secondary_id
2505
Identifier Type: -
Identifier Source: org_study_id