Efficacy and Safety of LAIS® Mites Sublingual Tablets

Study Overview
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Brief Summary
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Evaluation of the efficacy and safety of SLIT with LAIS® Mites Sublingual tablets compared to standard drug treatment in patients aged over 60 years suffering from house dust mite (HDM) induced allergic rhino-conjunctivitis with/without asthma.

Detailed Description
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The Total combined score (TCS), taking into account the rhinoconjunctivitis total symptom score (RTSS) and the total rescue medication score (RTMS), in the maximum expected mites exposition period (V4-V5) For the RTSS and the RTMS, the daily values as determined by the patients in their diary card are collected during the observation period over 30 days. Then, the mean daily scores during that period are calculated for both parameters.

Official Title
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Efficacy and Safety of LAIS® Mites Sublingual Tablets in Patients Aged Over 60 Years Suffering From House Dust Mite-induced Allergic Rhino-conjunctivitis With/Without Asthma

Conditions
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Allergic Conditions

Intervention / Treatment
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* Drug: LAIS®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female or male patients aged 60 years or more with a history of at least two years of house dust mite (HDM) induced allergic rhinitis and/or allergic rhinoconjunctivitis with or without mild to moderate controlled asthma upon exposure to house dust mite [From the Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2007. Clinically relevant sensitization to mites. 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) Retrospective Total Symptom Score (RRTSS) referred to the previous winter season greater than or equal to 8 Compliance and ability of the patient to complete a diary card for self-evaluation of the symptoms and anti-symptomatic medication Signed and dated patient's Informed Consent Exclusion Criteria: Simultaneous participation in other clinical trials Previous immunotherapy with mite allergens or cross reacting allergens within the last 5 years Ongoing immunotherapy with any allergen Patients being in any relationship or dependency with the sponsor and/or investigator 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) Predominant seasonal allergic rhinitis 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 Uncontrolled asthma Chronic asthma or emphysema, particularly with a forced expiratory volume <70% of the predicted value and /or <70% of the individual optimum value Infections of the oral cavity with severe symptoms Patients with Galactose-intolerance, Lactase-deficiency, Glucose-Galactose-malabsorption Active tuberculosis Generally inflammatory as well as severe acute and chronic inflammatory diseases Irreversible secondary disorders at the target organ (e.g. emphysema, bronchiectasis) Immune deficiency (for example induced by immunosuppressive drugs) Physician diagnosed diseases of the liver, spleen, nervous system, thyroidal gland as well rheumatic diseases, based on an autoimmune mechanism, Malignancy Alcohol abuse as well as drug and / or medication abuse Patients treated with contra-indicated drugs Contra-indication for adrenalin (for example, acute or chronic symptomatic coronary heart disease, severe hypertension, hyperthyroidism) Completed or ongoing long-term treatment with tranquilizer or psycho active drugs Completed or ongoing treatment with anti-Specific Immunoglobulin E-antibody Uncontrolled asthma according to GINA guideline criteria

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: active treatment<br>LAIS® Mites Sublingual tablets + rescue medication | Drug: LAIS®<br>* 10 X 1,000 / twice a week<br>* Other names: active treatment;|
| No Intervention: control<br>Rescue medication | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total combined score (TCS) | TCS = rhinoconjunctivitis total symptom score (RTSS) and the total rescue medication score (RTMS) | up to 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sublingual immunotherapy | usage of the Total Rescue Medication Score (RTMS) | up to 48weeks |