Status:
COMPLETED
Effects of Sublingual Immunotherapy on Grasspollen Allergy
Lead Sponsor:
Radboud University Medical Center
Conditions:
Hayfever
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
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...
Eligibility Criteria
Inclusion
- Age 18 and older.
- 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.
- Positive (ARTU) grass pollen specific skin prick test (despite negative RAST).
Exclusion
- Clinical history of severe asthmatic symptoms requiring inhalant therapy with daily pulmonary steroids during at least 3 months a year.
- 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.
- Other seasonal allergic rhinitis are not allowed unless it is asymptomatic during the period of provocation.
- The intention to subject the patient to surgery of the nasal cavity in the course of the study.
- Previous immunotherapy.
- Negative (ARTU) grass pollen specific skin prick test (despite positive RAST).
- 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
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00150514
Start Date
January 1 2002
End Date
December 1 2006
Last Update
September 8 2005
Active Locations (1)
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1
Radboud university hospital
Nijmegen, Gelderland, Netherlands, 6500