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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.
 
ClinicalTrials.gov Identifier: NCT00755066
Recruitment Status : Completed
First Posted : September 18, 2008
Last Update Posted : September 26, 2008
Sponsor:
Collaborator:
Allergy Centre Vienna West
Information provided by:
Medical University of Vienna

Tracking Information
First Submitted Date  ICMJE September 17, 2008
First Posted Date  ICMJE September 18, 2008
Last Update Posted Date September 26, 2008
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2008)
Allergen specific IgE levels [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2008)
Allergen specific IgG 1-4, IgM, IgA levels [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Intranasal Corticosteroids on Systemic Allergen Specific IgE
Official Title  ICMJE The Effect of Intranasal Corticosteroid on the Immune Response Following Nasal Allergen Challenge in Patients Suffering From Seasonal Allergic Rhinitis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Seasonal Allergic Rhinitis
Intervention  ICMJE
  • Drug: Fluticasone propionate
    200 µg intranasal, 4 weeks, od.
  • Drug: Placebo
    Placebo intranasal spray
Study Arms  ICMJE
  • Experimental: F
    Fluticasone propionate 200 µg intranasal
    Intervention: Drug: Fluticasone propionate
  • Placebo Comparator: P
    Placebo intranasal spray
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 25, 2008)
48
Original Actual Enrollment  ICMJE
 (submitted: September 17, 2008)
58
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00755066
Other Study ID Numbers  ICMJE 2505
EudraCT 2005-004274-24
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Medical University of Vienna
Collaborators  ICMJE Allergy Centre Vienna West
Investigators  ICMJE
Principal Investigator: Friedrich Horak, MD Medical University of Vienna
PRS Account Medical University of Vienna
Verification Date September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP