ISRCTN89345534
Completed
Not Applicable
Sublingual immunotherapy (SLIT) with grass pollen allergen for grass pollen induced rhinoconjunctivitis in childre
Artu Biologicals Europe B.V. (Netherlands)0 sites204 target enrollmentDecember 20, 2005
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Eye Diseases
- Sponsor
- Artu Biologicals Europe B.V. (Netherlands)
- Enrollment
- 204
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age; between 6 and 18 years.
- •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\. Moderate grass pollen allergy as retrospectively derived from allergy symptom scores during the previous grass pollen season. Therefore, the following 5 symptoms are evaluated for the previous season:
- •3\.1 Nasal blockage
- •3\.2 Sneezing
- •3\.3 Itching nose
- •3\.4 Watery running nose
- •3\.5 Itching eyes
- •The intention of each of these 5 symptoms is (subjectively) assessed by the patient according to a grading scale: 0 \= no complaints; 1 \= minor complaints; 2 \= moderate complaints; 3 \= serious complaints (maximal total value is 15\). At conclusion the retrospective total value should amount at least a value of 5\.
- •4\. Positive grass pollen specific IgE Rast test i.e. RAST score \= 2\+
Exclusion Criteria
- •1\. Clinical history of severe asthmatic symptoms requiring inhalant therapy with daily pulmonary steroids during at least 3 months a year
- •2\. Allergic sensitivity to epithelial, in case the domestic animal is present in the family home
- •3\. The intention to subject the patient to surgery of the nasal cavity in the course of the study
- •4\. Previous immunotherapy
- •5\. Contraindications to sublingual immunotherapy ie:
- •5\.1 Malignancies and serious disorders of the oral cavity
- •5\.2 History of status asthmaticus and anaphylactic shock
- •5\.3 Aggressively developing asthmatic symptoms
- •5\.4 Serious chronic inflammations, chronic disorders associated with fever, particularly of the bronchial tubes
- •5\.5 Irreversible, secondary changes in reactive organs (emphysema, bronchiectasis)
Outcomes
Primary Outcomes
Not specified
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