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Effect of Intranasal Corticosteroids on Systemic Allergen Specific IgE

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00755066
Recruitment Status : Completed
First Posted : September 18, 2008
Last Update Posted : September 26, 2008
Allergy Centre Vienna West
Information provided by:
Medical University of Vienna

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.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: Fluticasone propionate Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Intranasal Corticosteroid on the Immune Response Following Nasal Allergen Challenge in Patients Suffering From Seasonal Allergic Rhinitis

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

Arm Intervention/treatment
Experimental: F
Fluticasone propionate 200 µg intranasal
Drug: Fluticasone propionate
200 µg intranasal, 4 weeks, od.

Placebo Comparator: P
Placebo intranasal spray
Drug: Placebo
Placebo intranasal spray

Primary Outcome Measures :
  1. Allergen specific IgE levels [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Allergen specific IgG 1-4, IgM, IgA levels [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00755066

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Allergy Centre Vienna West
Vienna, Austria, 1150
Sponsors and Collaborators
Medical University of Vienna
Allergy Centre Vienna West
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Principal Investigator: Friedrich Horak, MD Medical University of Vienna
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00755066    
Other Study ID Numbers: 2505
EudraCT 2005-004274-24
First Posted: September 18, 2008    Key Record Dates
Last Update Posted: September 26, 2008
Last Verified: September 2008
Additional relevant MeSH terms:
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Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents