Effect of Intranasal Corticosteroids on Systemic Allergen Specific IgE

This study has been completed.
Sponsor:
Collaborator:
Allergy Centre Vienna West
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00755066
First received: September 17, 2008
Last updated: September 25, 2008
Last verified: September 2008
  Purpose

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 Intervention
Seasonal Allergic Rhinitis
Drug: Fluticasone propionate
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 NLM:


Further study details as provided by Medical University of Vienna:

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

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

Enrollment: 48
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755066

Locations
Austria
Allergy Centre Vienna West
Vienna, Austria, 1150
Sponsors and Collaborators
Medical University of Vienna
Allergy Centre Vienna West
Investigators
Principal Investigator: Friedrich Horak, MD Medical University of Vienna
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00755066     History of Changes
Other Study ID Numbers: 2505, EudraCT 2005-004274-24
Study First Received: September 17, 2008
Last Updated: September 25, 2008
Health Authority: Austria: Federal Ministry for Health and Women

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Fluticasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on August 20, 2014