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

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ClinicalTrials.gov Identifier: NCT02277483
Recruitment Status : Unknown
Verified June 2015 by Hae-Sim Park, Ajou University School of Medicine.
Recruitment status was:  Recruiting
First Posted : October 29, 2014
Last Update Posted : June 23, 2015
Sponsor:
Information provided by (Responsible Party):
Hae-Sim Park, Ajou University School of Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Allergic Conditions Drug: LAIS® Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2014
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: active treatment
LAIS® Mites Sublingual tablets + rescue medication
 Drug: LAIS®
10 X 1,000 / twice a week
Other Name: active treatment
No Intervention: control
Rescue medication


Outcome Measures
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Primary Outcome Measures :
  1. Total combined score (TCS) [ Time Frame: up to 48 weeks ]
    TCS = rhinoconjunctivitis total symptom score (RTSS) and the total rescue medication score (RTMS)


Secondary Outcome Measures :
  1. sublingual immunotherapy [ Time Frame: up to 48weeks ]
    usage of the Total Rescue Medication Score (RTMS)


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277483


Contacts
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Contact: yun-kyoung kim, Nr 82-31-219-4467 forsake326@gmail.com

Locations
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Korea, Republic of
Jung-Won Park Recruiting
Seoul, Korea, Republic of
Contact: JUNG WON PARK, M.D.,ph.D    82-2-2228-1966      
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
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Principal Investigator: hae-sim park, professor Department of internal medicine
More Information
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Responsible Party: Hae-Sim Park, professor, Department alleric internal medicine, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT02277483    
Other Study ID Numbers: MED-CT4-14-159
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: June 2015