UnknownPhase 4

Efficacy and Safety of LAIS® Mites Sublingual Tablets

South Korea45 participantsStarted 2014-10

Plain-language 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.

Who can participate

Age range60 Years

SexALL

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Inclusion criteria

✓. 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
✓. 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

Exclusion criteria

✕. 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
✕. 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)
✕. 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

What they're measuring

Total combined score (TCS)

Timeframe: up to 48 weeks

Trial details

NCT IDNCT02277483

SponsorAjou University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-07

Contact for this trial

yun-kyoung kim, Nr

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

View on ClinicalTrials.gov More Allergic Conditions trials