Patients suffering from allergic rhinoconjunctivitis MedDRA version: 14.1 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: LAIS Birch-Alder tablets
Pharmaceutical Form: Sublingual tablet
Other descriptive name: Chemically modified allergen extracts (monomeric allergoids) of tree pollen (Betula Pendula 50% an
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 birch and/or alder pollen-induced allergic rhinitis and/or allergic rhinoconjunctivitis with or without controlled seasonal allergic asthma ? Clinically relevant sensitization to birch and/or alder pollen. Patients with clinically relevant sensitization to other seasonal aero-allergens, for example ragweed, grass or rye may be included. However, patients with clinically relevant sensitization to perennial allergens like house dust mites, cats and dogs dander may not be included. ? Positive clinical history of birch and/or alder pollen induced allergic rhinitis, proven by o the majority of clinical symptoms appearing during the appropriate season for birch and alder pollen, and o positive skin prick test, and o positive response to conjunctival provocation testing (CPT) with one of the three solutions. The conjunctival allergen challenge will be conducted with solutions containing 100, 1,000 and 10,000 AU/ml tree allergens. ? Signed and dated patient’s Informed Consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 115 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: ? Simultaneous participation in other clinical trials ? Previous immunotherapy with tree allergens within the last 5 years ? Ongoing immunotherapy ? Patients being in any relationship or dependence 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 perennial allergic rhinitis ? Partly controlled or uncontrolled asthma ? Chronic asthma or emphysema, particularly with a FEV <70% of the predicted value ? Chronic asthma or emphysema, particularly with a PEF <70% of the individual optimum value ? 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 ? 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® Birch-Alder tablets will be assessed by the number of patients per treatment group with a change of the response threshold to induce a positive conjunctival provocation test (CPT), according to the evaluation defined by Riechelmann between the visits V1 and V4;Secondary Objective: Physical examinations and the description of the adverse events (frequency, intensity, severity and duration of adverse events) during the treatment with LAIS® Birch-Alder tablets;Primary end point(s): Number of patients per treatment group with a change of the response threshold to induce a positive conjunctival provocation test (CPT), according to the evaluation defined by Riechelmann between the visits V1 and V4.;Timepoint(s) of evaluation of this end point: Visit 1 and 4. | — |
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® Birch-Alder tablets.;Timepoint(s) of evaluation of this end point: Visits 1 - 4. | — |
Countries
Germany
Contacts
Public ContactCoordinating investigator
Institut für Med. Statistik, Informatik u. Epidemiologie
Outcome results
None listed