Efficacy and Safety of LAIS® Mites Sublingual Tablets

Phase 4

• Conditions: Allergic Conditions
• Interventions: Drug: LAIS®

• Registration Number: NCT02277483
• Lead Sponsor: Ajou University School of Medicine

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-20
• Study First Submitted QC: 2014-10-27
• Study First Posted: 2014-10-29
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-21
• Last Update Posted: 2015-06-23
• Primary Completion: 2016-07
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. 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.

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

1. Simultaneous participation in other clinical trials
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
active treatment	LAIS®	LAIS® Mites Sublingual tablets + rescue medication

Primary Outcome Measures

Name	Time	Method
Total combined score (TCS)	up to 48 weeks	TCS = rhinoconjunctivitis total symptom score (RTSS) and the total rescue medication score (RTMS)

Secondary Outcome Measures

Name	Time	Method
sublingual immunotherapy	up to 48weeks	usage of the Total Rescue Medication Score (RTMS)

Trial Locations

Locations (1)

Jung-Won Park; 🇰🇷 Seoul, Korea, Republic of