Efficacy and Safety of sublingual immunotherapy with Allergoid LAIS Birch tablets for patients with tree pollen-induced allergic rhinoconjunctivitis with or without mild controlled asthma

Phase 1

• Conditions: 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 Level: LLT Classification code 10066093 Term: Birch pollen allergy System Organ Class: 100000004870; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2018-002596-18-IT
• Lead Sponsor: OFARMA S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-17
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 110

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 < 2 mm),
5) Compliance and ability of the patient to complete a patient’s diary for self-evaluation of the symptoms, antisymptomatic medication and treatment compliance
6) Signed and dated patient´s Informed Consent

Special criteria for patients with co-sensitizations: for all patients with co-sensitizations all of the following inclusion criteria must be fulfilled:
1) Patients do not suffer from typical symptoms against co-seasonally prevalent allergens
2) Specific CAP-RAST results to co-seasonally prevalent allergens less than the CAP-RAST result to tree pollen (the difference has to be = 1), the patients with co-seasonally prevalent allergens against animal dander must not be exposed to the specific allergen
3) The result of the Skin Prick Test against co-seasonally prevalent allergens must be less than the result of the Skin Prick Test against birch / alder allergens

Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 102
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified