SUBLIVAC FIX Mite Mixture Dose Tolerability Study

Launched by HAL ALLERGY · Jan 23, 2015

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed informed consent
• • 2. Male or female patients, age ≥ 18 ≤ 60 years
• • 3. Patients with allergic rhinitis or rhinoconjunctivitis induced by HDM for at least 1 year, with or without concomitant at least partly controlled asthma
• • 4. Patients with a history of concomitant asthma should have a FEV1 \> 70% (of predicted value) at inclusion. Patients without a history of asthma should have a FEV1 \> 70% or a PEF \> 80% (of predicted value)
• • 5. Positive SPT to HDM D. pter or D. far (mean wheal diameter ≥ 3 mm compared to negative control; negative control should be negative; histamine control should be positive (mean wheal diameter ≥ 3 mm) at screening
• • 6. Allergen specific serum IgE (ssIgE) level in serum for HDM D. pter or D. far (\> 0.7 U/ml), assessed at screening
• Exclusion Criteria:
• • 1. Patients with concomitant sensitization i.e. positive SPT (mean wheal diameter ≥ 3 mm compared to negative control; negative control should be negative; histamine control should be positive (mean wheal diameter ≥ 3 mm) who are expected to have clinically relevant symptoms during the treatment period
• • 2. Patients sensitized and symptomatic to pets who are regularly exposed to pets
• • 3. Completed allergen-specific immunotherapy (SCIT or SLIT) with HDM within the last 5 years
• • 4. Completed unsuccessful allergen-specific immunotherapy (SCIT or SLIT) within the last 5 years
• • 5. Allergen-specific immunotherapy (SCIT or SLIT) with other allergens than HDM during the study period
• • 6. Any other vaccination one week before start of treatment and during the up-dosing phase
• • 7. Any anti-IgE therapy within the last 6 months prior to inclusion and during study
• • 8. Active inflammatory disease in the mouth (e.g periodontitis, oral mucosal lichen planus)
• • 9. Known hypersensitivity to any of the excipients (i.e. Disodium phosphate dihydrate, Sodium dihydrogen phosphate dihydrate, Aminocaproic acid, Glycerol, Peppermint oil, Caramel Colorant) of SLIT solution
• • 10. Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs
• • 11. Active malignancies or any malignant disease in the last 5 years
• • 12. A chronic or acute disease that in the opinion of the investigator might place the patient at an additional risk, including but not limited to the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine disorders, clinically significant renal or hepatic diseases, or haematological disorders
• • 13. Diseases with a contra-indication for the use of adrenaline (e.g. hyperthyroidism, glaucoma)
• • 14. Use of systemic corticosteroids 4 weeks before start treatment
• • 15. Treatment with systemic or local beta-blockers
• • 16. Clinically significant chronic sinusitis or ocular infection
• • 17. Participation in a clinical study with a new investigational drug within the last 3 months or a biological within the last 6 months prior to the study or during the study
• • 18. Pregnancy, lactation or inadequate contraceptive measures (acceptable forms of birth control include Intrauterine devices or hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or long-acting injections) or condom combined with a diaphragm including spermicidal cream). Also acceptable for women is surgical sterilization (removal of the uterus or ovaries or tubal ligation ("tied tubes")), if they are postmenopausal (12 consecutive months without a period) for at least 2 years, or having no sexual relationship with a man.
• • 19. Alcohol, drug, or medication abuse within the past year and during the study
• • 20. Any lack of co-operation or compliance
• • 21. Severe psychiatric, psychological, or neurological disorders
• • 22. Patients who are employees of the department or study site; 1st grade relatives, partners of the investigator, or patients who are dependent on the sponsor
• • 23. Any physical or mental condition that precludes administration of allergen-specific immunotherapy, compliance or participation in a trial
• • 24. Patients who are placed in an institution due to governmental or judicial directive