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Effects of Sublingual Immunotherapy on Grasspollen Allergy

This study has been completed.
Study NCT00150514.   Last updated on September 7, 2005.   Information provided by Radboud University

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Descriptive Information Fields
Brief Title  Effects of Sublingual Immunotherapy on Grasspollen Allergy
Official Title  A Placebo Controlled, Double-Blind, Randomised Study to Assess Efficacy of Sublingual Immunotherapy in Patients With Grass Pollen Allergy Through Assessment of Its Immunological Effects on the Mucosal Tissue of the Nose.
Brief Summary

The objective of the study is to document the objective immunological effects of SLIT on the nasal mucosa. Better understanding of these immunological pathways, in which this widely practised clinical therapy is likely to work, can only benefit the overall outcome of this, more patient friendly, therapy and it will demonstrate the effects of SLIT on the allergic reaction, with objective parameters, in the nasal tissues showing it to be a true etiological treatment of allergy.

Detailed Description

Double blind placebo controlled evaluation of the immunological effects (decrease of IgE specific cells and the decrease of Th2 mediator release, respectively increase of Th1 mediator release) of SLIT on the nasal mucosal tissue of adult humans with severe rhinocunjunctivitis due to grass pollen allergy.

Study Phase Phase IV
Study Type  Interventional
Study Design  Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Double blind placebo controlled evaluation of the immunological effects of SLIT on the nasal mucosal tissue of adult humans with sever
Secondary Outcome Measure  I. Correlating immunological effects to a retrospective subjective complaint reduction.
II. Rescue medication decrease through SLIT.
III. Determining the effects of SLIT on decongestion.
IV. Assessment of treatment compliance.
Condition  Hayfever
Intervention  Drug: Oralgen
Procedure: Nasal biopsy
Procedure: Nasal washing
Procedure: Peak nasal inspiratory flow
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  38
Start Date  January 2002
Completion Date December 2006
Eligibility Criteria 

Inclusion Criteria:

  1. Age 18 and older.
  2. Patients known in general practice with documented clinical history of grass pollen allergy with moderate disease intensity as retrospectively derived from the use of symptomatic allergy medication during the previous grass pollen season, i.e. regular use of cromoglycates as nasal spray and/or eye drops, and/or regular use of anti histamine tablets or sprays and/or limited use of local acting or systemically administered corticosteroids.
  3. Positive (ARTU) grass pollen specific skin prick test (despite negative RAST).

Exclusion Criteria:

  1. Clinical history of severe asthmatic symptoms requiring inhalant therapy with daily pulmonary steroids during at least 3 months a year.
  2. Symptomatic perennial allergic rhinitis. Meaning perennial allergy is allowed if the allergen is not present in patients' daily life (especially one month prior to provocation) and if they have no apparent symptoms of this perennial allergy.
  3. Other seasonal allergic rhinitis are not allowed unless it is asymptomatic during the period of provocation.
  4. The intention to subject the patient to surgery of the nasal cavity in the course of the study.
  5. Previous immunotherapy.
  6. Negative (ARTU) grass pollen specific skin prick test (despite positive RAST).
  7. Contraindications to sublingual immunotherapy, i.e.:

    • Malignancies and serious disorders of the oral cavity
    • History of status asthmaticus and anaphylactic shock
    • Aggressively developing asthmatic symptoms
    • Serious chronic inflammations, chronic disorders associated with fever, particularly of the bronchial tubes
    • Irreversible, secondary changes in reactive organs (emphysema, bronchiectasis)
    • Auto immune diseases and immunodeficiency
    • Concurrent therapy involving immunosuppressives
    • Systemic and collagen diseases
    • Tuberculosis of the lung and tuberculosis
    • Serious psychological disorders
    • Documented hypersensitivity to glycerol
    • Pregnancy
    • Serious cardiovascular disease
    • Usage of b -blockers
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  Netherlands
Administrative Information Fields
NCT ID  NCT00150514
Organization ID AB0103
Secondary IDs ††
Study Sponsor  Radboud University
Collaborators ††
Investigators 
Study Chair:     K Ingels, MD     Radboud University    
Information Provided By Radboud University
Verification Date November 2003
First Received Date  September 7, 2005
Last Updated Date September 7, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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