Efficacy and Safety of LAIS® Mites Sublingual Tablets (korLAIS)

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

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.

Study Overview

• Status: Unknown
• Conditions: Allergic Conditions
• Intervention / Treatment: Drug: LAIS®

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 Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: yun-kyoung kim, Nr; Phone Number: 82-31-219-4467; Email: forsake326@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Jung-Won Park
    • Contact: JUNG WON PARK, M.D.,ph.D; Phone Number: 82-2-2228-1966

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine
• Investigators: Principal Investigator: hae-sim park, professor, Department of Internal Medicine

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): July 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: October 20, 2014
• First Submitted That Met QC Criteria: October 27, 2014
• First Posted (Estimate): October 29, 2014

Study Record Updates

• Last Update Posted (Estimate): June 23, 2015
• Last Update Submitted That Met QC Criteria: June 21, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: MED-CT4-14-159