Patients suffering from allergic rhinoconjunctivitis MedDRA version: 16.1 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 100000004853
Conditions
Interventions
Product Name: Lais Mites Sublingual Tablets
Product Code: Lais Mites Sublingual Tablets
Pharmaceutical Form: Sublingual tablet
INN or Proposed INN: Lais Mites Sublingual Tablets
Other descriptive name
Sponsors
Lofarma S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ¨ Female or male patients aged 18–75 years with a history of at least two years of house dust mite (HDM) induced allergic rhinitis and/or allergic rhinoconjunctivitis with or without controlled asthma upon exposure to house dust mite [From the Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2012. Available from: http://www.ginasthma.org] ¨ Clinically relevant sensitization to mites. Patients with clinically relevant sensitization to seasonal aero-allergens occurring during the study period, for example grass or rye may not be included. Also patients with clinically relevant sensitization to perennial allergens like animal dander may not be included ¨ Positive clinical history of allergy due to house dust mite (HDM), proven by o The majority of perennial clinical symptoms appearing mostly related to indoor mites allergens o Specific IgE reactivity to mites allergens (CAP –radioallergosorbent test (CAP-RAST) = 2 o Positive skin prick test (wheal diameter > 3mm, negative control =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
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) ¨ Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection ¨ Predominant seasonal allergic rhinitis ¨ Partly controlled or uncontrolled asthma ¨ Chronic asthma or emphysema, particularly with a FEV <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, bronchoectasis) ¨ 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, ¨ Malignancy ¨ Alcohol abuse as well as drug and / or medication abuse ¨ Patients treated with contra-indicated drugs ¨ Contra-indication for adrenalin (for example, acute or chronic symptomatic coronary heart disease, severe hypertension, hyperthyroidism) ¨ Completed or ongoing long-term treatment with tranquilizer or psycho active drugs ¨ Completed or ongoing treatment with anti-IgE-antibody
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The efficacy of sublingual immunotherapy with the allergoid LAIS® Mites Sublingual tablets will be assessed by the mean improvement in the allergic severity S between baseline and visit V4, comparing the five treatment groups. Allergic severity S is rated by means of the severity stage integer values 0 = ci = 4. Here i is a number of an attempt (titration stage), made to reach a positive allergic reaction within the Conjunctival Provocation Test (CPT). CPT is considered positive if the response is stage 2 or higher. The maximum number of attempts (N) is restricted with the titration solutions available. If the severity stage is reached to be ci= 2, the CPT is considered as positive, the test is stopped for the current visit and N is the number of steps to reach a positive result (1, 2, 3). The titrated conjunctival allergen challenge will be conducted with solutions containing 100, 1,000 and 10,000 SQ-E/ml mite allergens.;Secondary Objective: · Physical examinations and the description of the adverse events (frequency, intensity, severity and duration of adverse events) during the treatment with LAIS® Mites Sublingual tablets · Documentation of the safety of the treatment with LAIS® Mites Sublingual tablets. · The changes of the threshold allergen concentration for a positive response within CPT will be compared for each of the five treatment groups. There will be three categories to detect the change in response threshold: Improved: A higher allergen concentration is required to induce a positive CPT response. Unchanged: The allergen concentration for a positive CPT is unchanged. Worse: A lower allergen concentration induces a positive CPT response. · Assessment of redness of the eye in CPT rated by a central observer;Primary end point(s): The efficacy of sublingual immunotherapy with the allergoid LAIS® Mites Sublingual tablets will be assessed by the mean improvement in the allergic severity S between baseline and visit V4, comparing the five tre | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): · Physical examinations and the description of the adverse events (frequency, intensity, severity and duration of adverse events) during the treatment with LAIS® Mites Sublingual tablets · Documentation of the safety of the treatment with LAIS® Mites Sublingual tablets. · The changes of the threshold allergen concentration for a positive response within CPT will be compared for each of the five treatment groups. There will be three categories to detect the change in response threshold: Improved: A higher allergen concentration is required to induce a positive CPT response. Unchanged: The allergen concentration for a positive CPT is unchanged. Worse: A lower allergen concentration induces a positive CPT response. · Assessment of redness of the eye in CPT rated by a central observer;Timepoint(s) of evaluation of this end point: Visit 0, Visit 1, Visit 2, Visit 3, and Visit 4 | — |
Countries
Germany
Contacts
Public ContactCoordinating Investigator
Institut für Med. Statistik, Informatik u. Epidemiologie
Outcome results
None listed