Patients suffering from allergic rhinoconjunctivitis MedDRA version: 17.1 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 100000004853
Conditions
Interventions
Product Name: LAIS Birch-Alder tablets
Product Code: LAIS Birch-Alder tablets
Pharmaceutical Form: Sublingual tablet
INN or Proposed INN: LAIS Birch-Alder tablets
Other descriptive name: Chemically mo
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 tree pollen induced allergic rhinitis and/or allergic rhinoconjunctivitis with or without seasonal controlled allergic asthma [From the Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2012. Available from: http://www.ginasthma.org] •Clinical sensitization to tree pollen. Patients with sensitization to perennial allergens like mites, cats and dogs may be included, in the case that these sensitizations are not clinically relevant during the evaluation season •Positive clinical history of tree pollen, proven by: -the majority of clinical symptoms appearing during the appropriate season for tree, -specific IgE reactivity to tree pollen CAP-radioallergoabsorbent test (CAP-RAST) = 2 (0.70 kU/L) -positive screening Skin Prick Test (wheal diameter > 3 mm, negative control =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: •Simultaneous participation in other clinical trials •Previous immunotherapy with birch-alder allergens or cross-reacting allergens within the last 5 years •Ongoing immunotherapy for any allergen •Patients being in any relationship or dependency with the sponsor and/or investigator •Other reasons contraindicating 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 (see Annex XX.3) •Predominant perennial allergic rhinitis •Partly controlled or uncontrolled asthma •Chronic asthma or emphysema, particularly with a FEV <70% of the predicted value and/or PEF <70% of the individual optimum value •Infections of the oral cavity with severe symptoms •Patients with Galactose-intolerance, Lactase-deficiency, Glucose-Galactose-malabsorption •Patients with nasal abnormalities and/or polyps •Active tuberculosis •Generally inflammatory as well severe acute and chronic inflammatory diseases •Immune deficiency (for example induced by immunosuppressive drugs) •Auto-immune disorders •Physician diagnosed diseases of the liver, spleen, nervous system, thyroidal gland as well as rheumatic diseases, based on an autoimmune mechanism •Malignancy •Alcohol abuse as well as drug and/or medication 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 •Patients treated with contra-indicated drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the efficacy of sublingual immunotherapy with the allergoid LAIS® Birch-Alder tablets by the Total Combined Score (TCS) taking in account the Rhinoconjuncticitis Total Symptom Score (RTSS) of the six rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes and the Total Rescue Medication Score (TRMS) for the peak of the birch pollen season. ;Secondary Objective: o TCS: a) for the birch pollen season of 30 days and b) for the entire tree pollen season of 60 days o Six individual symptom scores: a) for the peak birch pollen season of 14 days, b) for the birch pollen season of 30 days and c) for the entire tree pollen season of 60 days o RTSS: a) for the peak birch pollen season of 14 days, b) for the birch pollen season of 30 days and c) for the entire tree pollen season of 60 days o TRMS: a) for the peak birch pollen season of 14 days, b) for the birch pollen season of 30 days and c) for the entire tree pollen season of 60 days o Asthma rescue medication for the tree pollen season of 60 days o The mean improvement in the allergic severity S between baseline and visit V5 o The changes of the threshold allergen concentration for a positive response within conjunctival provocation test (CPT) o The “well days” o Birch pollen specific IgG4 o A global evaluation o Quality of Life o The rhinitis symptom control • Safety of the treatment ;Primary end point(s): The primary objective is to assess the efficacy of sublingual immunotherapy with the allergoid LAIS® Birch-Alder tablets by the Total Combined Score (TCS) taking in account the Rhinoconjuncticitis Total Symptom Score (RTSS) of the six rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes and the Total Rescue Medication Score (TRMS) for the peak of the birch pollen season.;Timepoint(s) of evaluation of this end point: 14 days of highest birch pol | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To assess the efficacy of a sublingual immunotherapy with the allergoid LAIS® Birch-Alder tablets related to o The Total Combined Score (TCS): a) for the birch pollen season of 30 days and b) for the entire tree pollen season of 60 days (March to April) o Six individual symptom scores of the Rhinoconjunctivitis Total Symptom Score (RTSS): a) for the peak birch pollen season of 14 days, b) for the birch pollen season of 30 days and c) for the entire tree pollen season of 60 days (March to April) o The Rhinoconjunctivitis Total Symptom Score (RTSS): a) for the peak birch pollen season of 14 days, b) for the birch pollen season of 30 days and c) for the entire tree pollen season of 60 days (March to April) o The Total Rescue Medication Score (TRMS): a) for the peak birch pollen season of 14 days, b) for the birch pollen season of 30 days and c) for the entire tree pollen season of 60 days (March to April), o The use of asthma rescue medication for the tree pollen season of 60 days (March to April) o The mean improvement in the allergic severity S between baseline and visit V5 within the conjunctival provocation test will be compared for both treatment groups. o The changes of the threshold allergen concentration for a positive response within conjunctival provocation test (CPT) will be compared for both treatment groups, according to the evaluation defined by Riechelmann H et al (2003) between baseline and visit V5. o The “well days”, being defined as days of the entire tree pollen season with a maximum symptom score of 2 and no rescue medication use according to Dahl (2006) and Durham (2006) o Assessment of birch pollen specific IgG4 o A global evaluation carried out by the patient for the total tree pollen season o To evaluate the Quality of Life by the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) o The rhinitis symptom control will be compared by RCAT between both treatment groups at the end of the tree pollen season • To docu | — |
Countries
Germany
Contacts
Public ContactCoordinating investigator
Institut für Med. Statistik, Informatik u. Epidemiologie
Outcome results
None listed