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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UNKNOWN
PHASE4
45 participants
INTERVENTIONAL
2014-10-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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active treatment
LAIS® Mites Sublingual tablets + rescue medication
LAIS®
10 X 1,000 / twice a week
control
Rescue medication
No interventions assigned to this group
Interventions
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LAIS®
10 X 1,000 / twice a week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Clinically relevant sensitization to mites.
3. Positive clinical history of allergy due to house dust mite (HDM), proven by- The majority of perennial clinical symptoms appearing mostly related to indoor mites allergens
* Specific Immunoglobulin E reactivity to mites allergens (ImmunoCAP\>0.35 Ku/L)
* Positive skin prick test (wheal diameter\> 3mm, negative control \< 2mm)
4. Retrospective Total Symptom Score (RRTSS) referred to the previous winter season greater than or equal to 8
5. Compliance and ability of the patient to complete a diary card for self-evaluation of the symptoms and anti-symptomatic medication
6. Signed and dated patient's Informed Consent
Exclusion Criteria
2. Previous immunotherapy with mite allergens or cross reacting allergens within the last 5 years
3. Ongoing immunotherapy with any allergen
4. Patients being in any relationship or dependency with the sponsor and/or investigator
5. Other reasons contra-indicating an inclusion into the trial according to the investigator's estimation (e.g. poor compliance, inability of the patient to understand study documents and instructions)
6. Predominant seasonal allergic rhinitis
7. Patients with clinically relevant sensitization to seasonal aero-allergens occurring during the study period may not be included. Also patients with clinically relevant sensitization to perennial allergens like animal dander may not be included
8. Uncontrolled asthma
9. Chronic asthma or emphysema, particularly with a forced expiratory volume \<70% of the predicted value and /or \<70% of the individual optimum value
10. Infections of the oral cavity with severe symptoms
11. Patients with Galactose-intolerance, Lactase-deficiency, Glucose-Galactose-malabsorption
12. Active tuberculosis
13. Generally inflammatory as well as severe acute and chronic inflammatory diseases
14. Irreversible secondary disorders at the target organ (e.g. emphysema, bronchiectasis)
15. Immune deficiency (for example induced by immunosuppressive drugs)
16. Physician diagnosed diseases of the liver, spleen, nervous system, thyroidal gland as well rheumatic diseases, based on an autoimmune mechanism,
17. Malignancy
18. Alcohol abuse as well as drug and / or medication abuse
19. Patients treated with contra-indicated drugs
20. Contra-indication for adrenalin (for example, acute or chronic symptomatic coronary heart disease, severe hypertension, hyperthyroidism)
21. Completed or ongoing long-term treatment with tranquilizer or psycho active drugs
22. Completed or ongoing treatment with anti-Specific Immunoglobulin E-antibody
23. Uncontrolled asthma according to GINA guideline criteria
60 Years
ALL
No
Sponsors
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Ajou University School of Medicine
OTHER
Responsible Party
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Hae-Sim Park
professor, Department alleric internal medicine
Principal Investigators
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hae-sim park, professor
Role: PRINCIPAL_INVESTIGATOR
Department of internal medicine
Locations
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Jung-Won Park
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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JUNG WON PARK, M.D.,ph.D
Role: primary
Other Identifiers
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MED-CT4-14-159
Identifier Type: -
Identifier Source: org_study_id
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