Effect of Intranasal Corticosteroids on Systemic Allergen Specific IgE

Medical University of Vienna

Status

Completed

Conditions

Seasonal Allergic Rhinitis

Treatments

Drug: Fluticasone propionate

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00755066

2505

EudraCT 2005-004274-24

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No 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