Efficacy and Safety of LAIS® Mites Sublingual Tablets

NCT02277483 | Unknown Phase 4 DMC

• 1 other identifier: MED-CT4-14-159
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Conditions

Outcome Measures

Primary Outcomes (1)

• Total combined score (TCS)

  TCS = rhinoconjunctivitis total symptom score (RTSS) and the total rescue medication score (RTMS)

  up to 48 weeks

Secondary Outcomes (1)

• sublingual immunotherapy

  up to 48weeks

Study Arms (2)

active treatment

ACTIVE COMPARATOR

LAIS® Mites Sublingual tablets + rescue medication

Drug: LAIS®

control

NO INTERVENTION

Rescue medication

Interventions

LAIS® DRUG

10 X 1,000 / twice a week

Also known as: active treatment

active treatment

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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,

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Jung-Won Park

Seoul, South Korea

RECRUITING

Study Officials

• hae-sim park, professor

  Department of internal medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yun-kyoung kim, Nr

CONTACT

82-31-219-4467; forsake326@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor, Department alleric internal medicine

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: October 29, 2014
• Study Start: October 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 23, 2015

Record last verified: 2015-06

Locations

KR (1)