Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
81 participants
INTERVENTIONAL
2015-05-31
2015-11-30
Brief Summary
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According to the European Medicines Agency Guideline on the clinical development of products for specific IT for the treatment of allergic diseases, products should be tested at different dosages to provide preliminary data on safety and tolerability with regard to the maximum tolerated dose and suitable dose escalation scheme. This trial is designed to investigate the tolerability and safety of different dosages of SUBLIVAC FIX Mite mixture.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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Placebo
once daily sublingual administration for 1 month
Placebo
Study medication will be taken sublingually once a day. Patients will start with one drop and increase the dose by one drop each consecutive day until the maintenance dose (5 drops/day) is reached. Drops should be kept under the tongue for 2-3 minutes before swallowing. After reaching the maintenance dose patients will be treated up to 1 month.
SUBLIVAC FIX Mite mixture 10,000 AU/mL
once daily sublingual administration for 1 month
SUBLIVAC FIX Mite mixture
Study medication will be taken sublingually once a day. Patients will start with one drop and increase the dose by one drop each consecutive day until the maintenance dose (5 drops/day) is reached. Drops should be kept under the tongue for 2-3 minutes before swallowing. After reaching the maintenance dose patients will be treated up to 1 month.
SUBLIVAC FIX Mite mixture 25,000 AU/mL
once daily sublingual administration for 1 month
SUBLIVAC FIX Mite mixture
Study medication will be taken sublingually once a day. Patients will start with one drop and increase the dose by one drop each consecutive day until the maintenance dose (5 drops/day) is reached. Drops should be kept under the tongue for 2-3 minutes before swallowing. After reaching the maintenance dose patients will be treated up to 1 month.
SUBLIVAC FIX Mite mixture 50,000 AU/mL
once daily sublingual administration for 1 month
SUBLIVAC FIX Mite mixture
Study medication will be taken sublingually once a day. Patients will start with one drop and increase the dose by one drop each consecutive day until the maintenance dose (5 drops/day) is reached. Drops should be kept under the tongue for 2-3 minutes before swallowing. After reaching the maintenance dose patients will be treated up to 1 month.
SUBLIVAC FIX Mite mixture 100,000 AU/mL
once daily sublingual administration for 1 month
SUBLIVAC FIX Mite mixture
Study medication will be taken sublingually once a day. Patients will start with one drop and increase the dose by one drop each consecutive day until the maintenance dose (5 drops/day) is reached. Drops should be kept under the tongue for 2-3 minutes before swallowing. After reaching the maintenance dose patients will be treated up to 1 month.
Interventions
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SUBLIVAC FIX Mite mixture
Study medication will be taken sublingually once a day. Patients will start with one drop and increase the dose by one drop each consecutive day until the maintenance dose (5 drops/day) is reached. Drops should be kept under the tongue for 2-3 minutes before swallowing. After reaching the maintenance dose patients will be treated up to 1 month.
Placebo
Study medication will be taken sublingually once a day. Patients will start with one drop and increase the dose by one drop each consecutive day until the maintenance dose (5 drops/day) is reached. Drops should be kept under the tongue for 2-3 minutes before swallowing. After reaching the maintenance dose patients will be treated up to 1 month.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
60 Years
ALL
No
Sponsors
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HAL Allergy
INDUSTRY
Responsible Party
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Principal Investigators
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Margitta Worm, Prof.Dr.med.
Role: STUDY_CHAIR
Allergie-Centrum-Charité
Locations
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Charite Universitatsmedizin Berlin, Allergiezentrum
Berlin, , Germany
Praxis Dr.med.Elke Hippke
Berlin, , Germany
HNO-Heilkunde Praxis
Chemnitz, , Germany
HNO und Allergologie Praxis
Dresden, , Germany
HNO-Praxis Dr. Uta Thieme
Duisburg, , Germany
Universitatsklinikum Dusseldorf, Department Dermatology
Düsseldorf, , Germany
HNO Praxis Gottingen
Göttingen, , Germany
HNO Praxis am Neckar
Heidelberg, , Germany
HNO Gemeinschaftspraxis
Heidelberg, , Germany
Dr.med. Ulrich Neumann Praxis
Wolmirstedt, , Germany
Countries
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Other Identifiers
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SM/0044
Identifier Type: -
Identifier Source: org_study_id