Efficacy and Safety of LAIS® Mites Sublingual Tablets

Allergic Conditions Clinical Trial

— korLAIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02277483
• Other study ID #: MED-CT4-14-159
• Status: Recruiting
• Phase: Phase 4
• First received: October 20, 2014
• Last updated: June 21, 2015
• Start date: October 2014
• Est. completion date: December 2016

Study information

• Verified date: June 2015
• Source: Ajou University School of Medicine
• Contact: yun-kyoung kim, Nr
• Phone: 82-31-219-4467
• Email: forsake326[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Conditions

Intervention

Drug:
• LAIS®
10 X 1,000 / twice a week

Locations

Country	Name	City	State
Korea, Republic of	Jung-Won Park	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total combined score (TCS)	TCS = rhinoconjunctivitis total symptom score (RTSS) and the total rescue medication score (RTMS)	up to 48 weeks	No
Secondary	sublingual immunotherapy	usage of the Total Rescue Medication Score (RTMS)	up to 48weeks	No