Sublingual immunotherapy (SLIT) with grass pollen allergen for grass pollen induced rhinoconjunctivitis in childre

Completed

Conditions: Rhinoconjunctivitis, Grass pollen allergy
Eye Diseases
Conjunctivitis

Registration Number: ISRCTN89345534

Lead Sponsor: Artu Biologicals Europe B.V. (Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 204

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)
5.6 Autoimmune diseases and immunodeficiency
5.7 Concurrent therapy involving immunosuppressives
5.8 Systemic and collagen diseases
5.9 Tuberculosis of the lung and tuberculosis
5.10 Serious psychological disorders
5.11 Documented hypersensitivity to glycerol
5.12 Pregnancy
5.13 Use of beta-blockers
6. Inability to communicate in the Dutch language
7. Exposure to any investigational drug within 30 days of enrolment