Tree pollen-induced allergic rhinoconjunctivitis MedDRA version: 20.0 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 100000004853 MedDRA version: 20.0 Level: LLT Classification code 10036019 Term: Pollen allergy System Organ Class: 100000004870 MedDRA version: 20.1
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: Allergenic extract (monomeric allergoid) from birch pollen
Current Sponsor code: Lais birch
Concentrati
Sponsors
LOFARMA S.P.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 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 mild seasonal controlled allergic asthma 2) Moderate/Severe Rhinoconjunctivitis defined according to ARIA guidelines (Brozek JL et al., 2016) and Retrospective Symptoms Score >12, as sum of the score (0-3) for each of the six nasal and conjuntival symptoms referred to the previous trees pollen season (range 0-18) 3) 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 4) Positive clinical history of tree pollen, proven by: - the majority of clinical symptoms appearing during the appropriate season for tree, - specific IgE reactivity for Bet v1 (immuneCAP) = 2 . (If IgE specific are performed before the inclusion in the study, at the moment of clinical diagnosis in the year 2018, can be used as screening data) - 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 8
Exclusion criteria
Exclusion criteria: 1) Simultaneous participation in other clinical trials; 2) Clinically relevant hypersensitivity to any of the excipients used in LAIS Birch sublingual tablets or in placebo tablets (lactose monohydrate, cellulose microcrystalline, silica colloidal anhydrous and magnesium stearate); 3) Previous immunotherapy with tree allergens or cross-reacting allergens within the last 5 years; 4) Ongoing immunotherapy with any allergen; 5) Patients being in any relationship or dependency with the sponsor and/or investigator; 6) 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); 7) Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection; 8) Patients for which the antiallergic or antiasthmatic treatment with the following drugs is contraindicated: local Levocabastine (eye), Loratadine (oral), Beclomethasone (nasal), Prednisone (oral) 9) Predominant perennial allergic rhinitis; 10) Diagnosis of choanal atresia, chronic rhinosinusitis with nasal polyps, septal perforation, severe septal deviation, atrophic rhinitis, adenoids obstructing nasal ventilation; 11) Asthma requiring treatment other than short-acting inhaled ß2-agonists and low-dose inhaled corticosteroids and/or severe asthma or history of uncontrolled/partly controlled asthma; 12) Chronic asthma or emphysema, particularly with a FEV <70% of the predicted value and/or PEF <70% of the individual optimum value; 13) Severe oral inflammation or oral wounds at randomization; 14) Patients with Galactose-intolerance, Lactase-deficiency, Glucose-Galactose-malabsorption; 15) Clinically relevant nasal polyps, history of surgery either of paranasal sinus or of nasal turbinates, and/or elective maxillofacial surgery within 6 months before planned treatment start (randomization); 16) Active tuberculosis; 17) Generally inflammatory as well severe acute and chronic inflammatory diseases; 18) Any clinically relevant chronic disease (e.g. cystic fibrosis, emphysema, malignancy, malabsorption or malnutrition, renal or hepatic abnormality, chronic infections, or any other diseases that, in the opinion of the investigator, would interfere with the trial evaluations or the safety of the subjects); 19) Immune deficiency (for example induced by immunosuppressive drugs); 20) Systemic disease affecting the immune system (e.g., insulin dependent diabetes, severe active autoimmune disease, immune complex disease or immune deficiency disease); 21) Physician diagnosed diseases of the liver, spleen, nervous system, thyroidal gland as well as rheumatic diseases, based on an autoimmune mechanism; 22) Malignancy; 23) Alcohol abuse as well as drug and/or medication abuse; 24) Contra-indication for adrenalin (for example, acute or chronic symptomatic coronary heart disease, severe hypertension, hyperthyroidism); 25) History of anaphylaxis grade 3 or 4 according to Ring et al.; 26) History of recurrent (defined as at
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the efficacy and safety of tablet-based SLIT with the monomeric allergoid LAIS Birch tablets compared to placebo in patients with tree pollen-induced allergic rhinoconjunctivitis with or without mild asthma.;Secondary Objective: to evaluate the efficacy and safety of tablet-based SLIT with the monomeric allergoid LAIS Birch tablets compared to placebo in patients with tree pollen-induced allergic rhinoconjunctivitis with or without mild asthma.; Primary end point(s): Assessment of the efficacy of the sublingual immunotherapy with the allergoid LAIS Birch tablets on a “Total Combined Score (TCS)” for the 14-days peak of the birch pollen season taking into account: • a “Rhinoconjunctivitis Total Symptom Score (RTSS)”, of the six rhinoconjunctivitis symptoms sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes. And • a “Total Rescue Medication Score (TRMS)”, taking into account the use of oral antihistamines, Levocabastine eye drops and nasal corticosteroids, oral corticosteroids ;Timepoint(s) of evaluation of this end point: 14-days peak of the birch pollen season | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) To assess the efficacy of a sublingual immunotherapy with the allergoid LAIS Birch tablets related to the Total Combined Score (TCS) 2) The Rhinoconjunctivitis Total Symptom Score (RTSS) 3) Rhinoconjunctivitis Total Symptom Score (RTSS) 4) The “well days”, being defined as days of the entire tree pollen season with a maximum symptom score of 2 and no rescue medication 5) Six individual symptom scores of the Rhinoconjunctivitis Total Symptom Score (RTSS) 6) A global evaluation carried out by the patient for the total tree pollen season, to evaluate the Treatment Satisfaction 7) To document the safety of the treatment by the physical examinations, the description of the adverse events (frequency, intensity, severity and duration of adverse events) and the safety laboratory data during the treatment with LAIS Birch tablets ; Timepoint(s) of evaluation of this end point: 1) a) for the birch pollen season of 30 days and b) for the entire tree pollen season of 60 days (March to April) 2) 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) 3) 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) 4) Entire tree pollen season 5) 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) 6) Total tree pollen season 7) 6 months | — |
Countries
Italy
Contacts
Public ContactCRO
CD Pharma Group Srl
Outcome results
None listed