Study With High Dose PURETHAL Mites in Allergic Rhinitis/Rhinoconjunctivitis Patients

Launched by HAL ALLERGY · Sep 8, 2009

Keywords

ClinConnect Summary

The tolerability and safety of three different initial treatment regimens PURETHAL mites in patients with allergic rhinitis / rhinoconjunctivitis induced by house dust mites will be evaluated and the optimal regimen to reach the maximum tolerated dose will be determined. The maximum intended dose is a 4-fold dosage compared to the currently used maintenance dose of PURETHAL Mites. The tolerability and safety of the injections will be examined by means of determining the early and late local and systemic reactions. In addition, short-term efficacy of this high dose PURETHAL mites will be det...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with perennial rhinitis or rhinoconjunctivitis, with or without mild asthma (FEV1 \> 70%) for at least 2 years. with allergic symptoms related to HDM
• • 2. Positive CPT test to HDM Der p, dose ≤10,000 AUeq/ml
• • 3. Positive SPT to HDM Der p or Der f (mean wheal diameter ≥ 3mm)
• • 4. Specific serum IgE-test (ssIgE \> 0.7 U/ml) for HDM
• • 5. Age ≥ 18 years
• • 6. Written informed consent given
• Exclusion Criteria:
• • 1. Patients with concomitant sensitization i.e. positive SPT (mean wheal diameter ≥ 3 mm) to other allergens than HDM should not be included if they have clinical symptoms at the time of inclusion, related to the other allergen
• • 2. Patients sensitized to pets should not be included if they live together with these pets or have clinical symptoms
• • 3. Immunotherapy (including sublingual) with HDM within the last 5 years
• • 4. Immunotherapy (including sublingual) during the study period
• • 5. Chronic asthma or emphysema, particularly with a FEV1 ≤ 70% of predicted value or use of inhalation corticosteroids
• • 6. Serious immuno-pathologic diseases or malignancies (including auto-immune diseases, tuberculosis)
• • 7. Symptomatic coronary heart diseases or severe (even under treatment) arterial hypertension
• • 8. Diseases with a contra-indication for the use of adrenaline
• • 9. Patients who are using other aluminium preparations, e.g. antacids
• • 10. Severe kidney disease
• • 11. Use of systemic steroids
• • 12. Treatment with systemic and local Beta-blockers or immunosuppressive drugs
• • 13. Active infection of the target organs (nose or eyes)
• • 14. Severe atopic dermatitis in case systemic immunosuppressive medication is used
• • 15. Participation in a clinical study with a new investigational drug within the last 3 months
• • 16. Pregnancy, lactation or inadequate contraceptive measures (adequate contraceptive measures will be the use of a contraceptive device or -pill)
• • 17. Alcohol- or drug abuse
• • 18. Lack of co-operation or severe psychological disorders
• • 19. Institutionalisation by official or judicial order